Jobs That Crossed My Desk Through June 2, 2013 Complimentary Service of Audreysnetwork.com

June 2, 2013

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org.

*************************************************************************** Apply on company website Senior Chemist Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== Our client is looking for a Senior Chemist with solid laboratory experience from the pharmaceutical industry. Specifically, we are looking for someone who is able to handle the following responsibilities... 1) Perform a variety of analyses related to departmental functions 2) Operate lab equipment according to specifications and accurately reports results of work 3) Utilize advanced knowledge and training in method development, validation/verification 4) Utilize hands-on and theoretical knowledge of various analytical instruments for quality control tests 5) Involve in industry related activities to better the company's position in the industry 6) Apply skills to develop a series of more complex procedures or experiment or perform technical tasks requiring a significant degree of competence, knowledge, skill and training 7) Utilize knowledge of a wide variety of chemistry tests, analyses or experimental techniques using standard lab equipment 8) Create, co-ordinate and maintain work schedules, projects, instruments, facilities, and documentation while exercising independent judgment

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9) Prepare simple quotations or proposals 10) Comply with cGMP, GLP and laboratory safety practices 11) Special projects as assigned Qualifications and Desired Skills ====================== 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply) 2) Appropriate full-time work experience is mandatory (no students or fresh graduates please) 3) Recent experience in the pharmaceutical industry is strongly preferred 4) Preference will be given to people who have recent experience in research and development This could be an once-in-a-lifetime opportunity for the right person who is looking to make a positive career change. If you think this could be you, please apply! More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/R-AND-D-Science-California-Biotechnology-Jobs-Careers-102568 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time).

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Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:May 29, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:1111481102568 Job ID:5870790 __________________________________________________________ Regulatory Affairs Manager Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: resumes@sterlinglifesciences.com (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== Our client is a leading medical device company and is currently seeking an accomplished Regulatory Affairs Manager to join the team. Here is an overview of the role: 1) Develop regulatory pathways, which can ensure successful regulatory submissions 2) Provide a summary of needed elements for a clear strategy of submission 3) Maintain up-to-date knowledge of laws, regulations and policies enforced by the federal and state governments 4) Co-ordinate and supervise the development of regulatory strategies for investigation, new or modified products 5) Provide support for the regulatory department to ensure efficient and compliant business processes and environment 6) Establish and maintain regulatory information systems 7) Prepare and manage timely regulatory submissions as needed 8) Communicate regulatory information to multiple departments and ensure that information is interpreted correctly 9) Assist with preparing periodic safety reviews 10) Manage documentation efforts to ensure compliance with domestic and international regulations and standards Qualifications and Desired Skills ====================== 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply) 2) Appropriate full-time work experience is mandatory (no students or fresh graduates please) 3) Recent experience in the medical device industry is strongly preferred 4) Preference will be given to people have recent experience in regulatory affairs management Our client is seeking an enthusiastic individual who can bring added value and a new approach

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to their business. If you believe this is a challenge you can be successful at, please apply ASAP. More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-92345 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthcare, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific, Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility Company Description Sterling-Hoffman is a retained executive search firm that represents venture capital firms and their portfolio companies in matters of high impact talent acquisition, focused on Biotechnology, Medical Device, Pharmaceuticals, and High Tech (Software/Web companies). You can view more of our job postings at: http://goo.gl/uTzVl We respect your privacy. Your resume will *never* be shared without your permission. If you want to know the status of your application, send a PRIVATE message to our CEO (Angel Mehta) on Twitter: www.twitter.com/sterlinghoffman Tip: Make sure you mention the job title and location you applied to when asking for a status update. He will respond to you privately within 48 hours (most of the time). Remember: to apply for this position, click the ‘Apply’ button on Linkedin and complete the form. If you have trouble uploading your resume, email your resume to: resumes@sterlinglifesciences.com Additional Information Posted:May 27, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:111146192345 Job ID:5844237 **************************************************************

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Apply on company website To apply: Visit http://tinyurl.com/k83he4u or www.BMRN.com Sr. Supervisor/Manager, Contract Manufacturing BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY This role provides day-to-day oversight for small molecule drug substance contract manufacturing activities. Responsibilities include project management; implementation and tracking of Electronic Business Systems inputs and cGMP change control tracking; coordination with contractors and BioMarin Manufacturing, Quality, and Regulatory Affairs personnel and programs. Position may interact with contractors’ development and process chemists to assess and improve current processes. The position may serve as BioMarin’s person-in-the-plant for both critical and routine production activities. RESPONSIBILITIES • Monitor current contract manufacturing operations associated with both marketed and clinical-phase small molecule products and suggest improvements. Create justifications for change: cost-of-goods, product quality; streamlined procedures. • Establish and monitor project timelines, develop success criteria; maintain tight coordination with drug product production schedules and ensure continued supply of drug substance to those operations. Provide and monitor production data for budget cycles • Work with Contract Manufacturing management and contractors to identify process improvements, coordinate transfer and implementation of those changes, and monitor ongoing improvements at large scale to ensure success. • Communicate and coordinate BMRN evaluation of process changes, change requests, deviations, and OOS findings. Coordinate with BMRN and contractor QA groups to ensure timely evaluation and approval of master and executed batch records. • In coordination with contractors and BMRN Drug Product manufacturing personnel, manage product inventory and shipping events to maintain drug substance supply for further manufacturing operations. • Coordinate with contractor and BMRN quality and regulatory personnel to support regulatory submissions to implement new procedures. • Other duties as assigned, including participation in contractor GMP audits and providing assistance to BMRN drug product manufacturing efforts when needed. To apply: Visit http://tinyurl.com/k83he4u or www.BMRN.com Desired Skills & Experience EDUCATION BS in a scientific field, preferably Chemistry or Chemical Engineering with a focus on organic chemistry (Supervisor level) or MS/PhD/work experience (higher levels). Working knowledge of organic chemistry at both the research level and in large-scale GMP production. Working knowledge of pharmaceutical regulatory requirements appropriate to level and solid cGMP skills required. Able to read and understand patents and contracts; facile understanding and use of English required. German and French language skills greatly desired. EXPERIENCE A minimum of 2-4 years of related experience is required (Sr. Supervisor); for consideration as Manager, at least two years associated with large-scale chemical manufacturing. Late stage pharmaceutical development experience a plus. Familiarity and/or working with Oracle EBS format and Trackwise documentation systems are desirable but not required. To apply: Visit http://tinyurl.com/k83he4u or www.BMRN.com Company Description At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious

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diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them. Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us. EEO/M/F/D/V Additional Information Posted:May 31, 2013 Type:Full-time Experience:Mid-Senior level Functions:Manufacturing Industries:Biotechnology Job ID:5906058 _____________________________________________________ Manager/Sr. Manager, Technical Services To apply: Visit http://tinyurl.com/l523ero or www.BMRN.com BioMarin - Novato, CA (San Francisco Bay Area) Job Description SUMMARY The Manager will oversee and provide technical guidance on troubleshooting technical issues, develop and implement new manufacturing processes at CMO sites, and lead the development of a combination product (PFS) as well as any new dosage forms. RESPONSIBILITIES

Lead the design control process for combination products by defining technical specifications, generating design control related documentation, and manage design reviews.

Assist department managers with technical assessments and new process development. Act as a project manager for technical projects to be implemented at CMO sites. Interface/coordinate with Formulations and Quality on product/process development.

To apply: Visit http://tinyurl.com/l523ero or www.BMRN.com Desired Skills & Experience EDUCATION Bachelor’s Degree in Engineering preferred along with Project Management training. Experience in combination products/devices preferred. Thorough knowledge of medical device regulations required. EXPERIENCE

Minimum 10 years experience in pharma, biotech, or device environments with experience in new product development.

Technical leadership/commercial launch of multiple products/devices preferred. Must have experience leading diverse teams in product development projects

To apply: Visit http://tinyurl.com/l523ero or www.BMRN.com Company Description At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We

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hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them. Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us. EEO/M/F/D/V Additional Information Posted:May 31, 2013 Type:Full-time Experience:Mid-Senior level Functions:Manufacturing Industries:Biotechnology Job ID:5905877 ********************************************************** Apply on company website Director, Regional Marketing Affymetrix, Inc. - Santa Clara, California (San Francisco Bay Area) Job Description Marketing Director, IMG This position will lead the Affymetrix' International Marketing efforts in Latin America, Asia Pacific, Eastern Europe, MENA region, China and Japan. The marketing director will be responsible for inspiring training and motivating a relatively new Marketing Groupm including 4 direct reports, 3 Regional Marketing Managers and a Marcoms Manager. The IMG Marketing Director will oversee the marketing programs and tactical marketing activities across all Affymetrix Business Units including eBioscience and Panomics. The group lead by the marketing director will be responsible for designing and implementing demand generation programs, training the sales team and channel partners, technology evangelism, tactical marketing activities, support of key accounts, KOL development and localization of marketing materials. The successful candidate will be required to interface with cross functional teams including, Sales, Distributors, Business Units and Other Regional Marketing Managers. Therefore excellent communication skills are a key requirement for the role including a strong command of English. The role will also require building the Affymetrix brand presence across IMG, having a vision of new applied markets that Affymetrix can enter, scope out new product opportunities for the local markets and directing and motivating the team to execute these to fruition. The role will be based in Santa Clara or within the region it supports and will require 50% travel internationally. Key job functions include: Leading the marketing team - Train and manage the team to inspire optimal performance through excellent people management and team development skills, including recruitment and hiring, performance management, team building, annual goal setting and career development Build marketing operations - Since this is a newly formed marketing group, the marketing director will be required to build processes and SOPs which work well with the marketing services group in Santa Clara. In addition to this, build a structure for accurate regionalization of materials. Budget Management Manage and prioritize the IMG Ad and Promo budget Visionary for new markets - Set and execute a clear strategy for new and applied markets for Affymetrix IMG , including but not exclusively , AgBIo, TCM, Nutrigenomics, Fitness and lifestyle and other clinical products for the local market.

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New Marketing Initiatives - Add new marketing capabilities as required, including telemarketing, e commerce and marketing 2,0. Training Responsible for training all the sales teams of our direct and indirect channels in IMG. Sales training will be on the products, applications and customers in addition to the new challenger sales initiative. Customer Facing Marketing Material Task with creating and localizing customer facing selling tools, eg slide decks and brochures designed to empower the sales team and distributors to sell the portfolio effectively Create and Execute Tactical Plan to ensure that revenue goals are met This will include campaigns, value propositions, sales tools as well as monitoring of competitor activities and creating defense plans and tools and responses to counteract these. Customer and Field Feedback Monitor and gather market dynamics on competitor activities, emerging applications, customers needs, and providing feedback to the product marketing team for new product development, pricing and positioning recommendation Local Market Opportunities Identifying revenue generating opportunities that may be unique to China, through new products, new markets and new applications. Key Competencies:

Excellent commercial skills, being able to balance both customer and company expectations

Proven ability to design and execute highly effective marketing campaigns and programs

Strong cross-functional execution experience. Takes initiative without being coached. Excellent planning and scheduling skills. Knowledge of key accounts and key clinical researchers. Min BSc in the life sciences Min 7 Years Marketing or Sales Experience within the life sciences industry Strong communication skills, written, verbal and in Public speaking Strong computer literacy skills Travel min 50% of the time

Additional Duties and Responsibilities:

Builds marketing program strategies and campaigns Partners cross-functionally on definition and execution of the marketing program Develops and drives outbound, demand-generating, customer-facing marketing

programs to key market segments Collaborates cross-functionally to ensure consistent positioning and messaging to target

customers Measures program success through tracking and metrics and impact to the business Assists in providing customer feedback for the development of market requirements Prioritizes projects and resources based on business strategies Selects, develops, and evaluates personnel Leader of company operations, policies, and procedures Leads and works effectively with cross-functional teams Additional duties/responsibilities according to business needs

Requirements: Required Preferred

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Education: Bachelor's Master's Yrs of related experience: 7-10 years managerial 8-10 years managerial Competencies: (skills, knowledge, abilities) Interpersonal skills, Results or Goals oriented, Technical/Professional capability, Credibility, Influencing, Change Leader Program Project Management Licenses/Certificates: None None Travel Requirements: >25% >25% Working Conditions: Office and Field Environment Office and Field Environment Level of Autonomy and Complexity:

Ensures meeting of operational objectives; contributes to development and execution of strategic company policies and objectives; finalizes decisions on administrative/operational matters

Works on problems that require deep understanding of company; contributes to development of evaluation criteria and techniques for projects; ensures budgets/schedules meet corporate requirements

Directs activities of managers in broad functional area; has control over goals, budget, staffing, planning, etc; recommends and institutes changes to practices

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Errors in judgment or failure to accomplish goals will have threatening impact on overall success of company

ABOUT AFFYMETRIX Affymetrix (AFFX) is a pioneer in creating breakthrough tools that are driving the genomic revolution. Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and biotechnology companies, as well as leading academic, government, and nonprofit research institutes. The vision, innovation, and devotion of Affymetrix employees help us empower scientists around the world to alleviate human suffering. It is not just the sheer power of our technology that inspires us; it is the potential for it to help people. Our employees create a highly energized, team-oriented work environment. We are an employer committed to supporting the aspirations and achievements of our employees and offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values of daring, passionate and platinum. •••Affymetrix is an affirmative action/equal opportunity employer. We do not discriminate based on race, gender, veteran status, disability or other protected status. Our commitment to a diverse workforce is demonstrated through all aspects of our hiring and employment practices. Additional Information Posted:May 14, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Biotechnology Employer Job ID:9682 Job ID:5721480 *********************************************************************** Apply on company website—Posted by Nina Osmon Sr. Director Marketing - KI Franchise Onyx Pharmaceuticals- South San Franciso (San Francisco Bay Area) Job Description Sr. Director of Marketing for the KI Franchise is responsible for leading the KI Franchise US marketing team, with ultimate accountability for achieving or exceeding assigned sales goals and commercial margin. Essential/Primary Duties, Functions and Responsibilities:

Leads KI Franchise U.S. Marketing team Ensures team is motivated, and functioning and performing at or above expectation Accountable for highly successful industry leading performance of assigned brands Defines/establishes brands KPIs, and holds self and team accountable for achieving

goals Lead the development of co-promotion strategic plans in collaboration with Alliance

Partner. Assures that Onyx’s vision is reflected in the plan. Oversees development and execution of tactical plan Supports and provides input into lifecycle planning for KI franchise, LRP, and annual

planning cycle deliverables for the franchise Partners closely with sales management to ensure pull through and execution of brand

plan Drive to consensus with Alliance Partner on plan, budget and forecasts. Develop and implement strategic marketing plans. Align medical education and

promotional activities to achieve corporate objectives for products and services. Develop both short- and long-range strategies for assigned products

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Explore and evaluate new strategic concepts opening up new opportunities. Utilize and plan for needed market research that informs and influences product

strategy to meet changing market and competitive conditions. Ensures product communications are coordinated, support marketing plan objectives

and meet organizational expenditure requirements in conjunction with the leadership team

Understands and utilizes competitive intelligence Reports on function’s progress against corporate goals to senior management team. Establish and maintain productive working relationships with Onyx commercial partners

and with internal partners in global business analytics, global product strategy, medical affairs, clinical development and commercial finance.

Regularly interacts with KOLs to establish and cultivate relationships. Other duties as defined

Desired Skills & Experience Requirements Work Experience:

10+ years Industry experience 7+ years Marketing experience 5+ years Management experience 5+ years Oncology experience Sales experience Global Marketing/Lifecycle Management experience preferred

Management of Staff: Experience leading and developing teams including people managers will be required

Functional/Technical Knowledge & Skills: Motivational leadership style Strong business, commercial and clinical acumen Strategic thinking with the ability to formulate, develop and execute comprehensive

plans Strong influence & negotiating abilities Effective communication skills Excellent organizational and analytical skills Innovation and problem solving skills

Customer & Industry Knowledge: Demonstrates knowledge of disease states, Onyx products and competitive

environment Deep knowledge and understanding of markets where KI franchise products play a role Knowledge of pharmaceutical industry, relevant regulations and laws Knowledge of the business of oncology

Education/Training: Bachelors Degree required MBA or other Master’s degree strongly recommended Scientific background a plus

Other Requirements: Highly motivated, ability to be effective in a rapidly changing, small company

environment Competencies

Functional competencies in product strategy & commercialization Behavioral competencies in working with teams, collaboration in an unstructured,

rapidly growing environment Strategic agility and leadership Building and leading teams Market development

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Collaboration Innovation Results orientation/process excellence

Company Description Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com. Additional Information Posted:May 6, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Pharmaceuticals Job ID:5627344 ************************************************************************ http://www.linkedin.com/jobs?viewJob=&jobId=5732667&trk=jobs_seeking_view_job&goback=%2Evjs_5643461_*2_*2_*2_false_*2_*2%2Evjs_5611144_*2_*2_*2_false_*2_*2 Posted by Susanne Buelna , Sr.Human Resources Manager at Nitto Denko & Co-Owner Green Jungle, Inc. Vice President, Clinical Development Nitto Denko Technical- Greater San Diego Area Job Description Nitto Denko Technical Corporation VP, Clinical Development Summary & Scope of Position: Lead the Clinical Research Group and supervise personnel, including activities related to clinical operations, clinical research programs and medical affairs. Provide medical expertise related to Nitto Denko Technical Corporation (NDT) products and development programs. Interact with external organizations (e.g., medical, scientific, business and government groups) on behalf of NDT. Primary Responsibilities: · Interact with NDT management to define and develop clinical strategies consistent with business objectives and regulatory requirements. · Direct activities related to phase 1-4 clinical trials (e.g., protocol development, design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, and study analysis and reporting). · Ensure CRMA adherence to national and international regulations and standards (GCP, MDD, ICH). · Oversight of adherence to protocols and regulatory requirements, assuring safety of study subjects. · Review adverse events, monitor safety and prepare analysis and regulatory submission.

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· Participate in the review and editing of regulatory submissions and quality documentation. · Interact with Marketing and Global Scientific Affairs for strategic positioning and support of clinical trials and needed medical data. · Interact with Regulatory Affairs for positioning regulatory strategy. · Cultivate and maintain key relationships with outside business partners, scientific and clinical advisors, and therapeutic thought-leaders. · Oversee operational activities and CRMA personnel including clinical research, drug safety and biostatistics. · Manage and participate in human resources/organizational development activities including; recruitment of key CRMA personnel, performance management, employee development and training. · Ensure budgets and schedules are met. · Participate in scientific publications and presentations; and review of publications to insure consistency with corporate objectives. · Provide clinical trials result data in medical journals and present results at conferences and symposiums. · Ensure quality system compliance as it relates to area of responsibility. · Perform other related duties as required. Desired Skills & Experience Qualifications/Requirements: · MS degree: Working knowledge in the areas of Hepatology, GI, Oncology, Internal Medicine and Infectious disease. Would prefer but not required for our candidate to have liposome and SiRNA experience. · Minimum of 15 years clinical trial experience; includes 6-8 years management background. · Demonstrated significant, successful ability to conduct clinical development in an industry setting. · Thorough understanding of regulatory requirements. · Strong negotiation skills to influence policy making bodies both internally and externally. · Ability to integrate clinical expertise with NDT business objectives; strong sense of Company with ability to translate corporate goals into project plan. · Recognized as an effective leader; strong leadership, management and mentoring skills; team oriented. · Ability to effectively communicate (encompasses verbal, written, interpersonal, listening); ability to communicate across multiple disciplines successfully (internally and externally). Company Description Nitto Denko Technical Corporation (NDT) was established in Oceanside, California in October 2000 as an independent centre of excellence for research and development into new growth engines for its parent company, Nitto Denko Corporation (www.nitto.com), based in Osaka, Japan. NDT focuses on cutting edge technologies that will provide practical solutions for leading industry sectors such as Pharmaceutical, Biotechnology, Optronics and others into the next decade and beyond. Our long term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make NDT a vibrant and exciting center of new ideas and brilliant technologies. Additional Information Posted:May 15, 2013 Type:Full-time Experience:Executive Functions:Other Industries:Biotechnology Job ID:5732667 ***********************************************************************

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http://www.linkedin.com/jobs?viewJob=&jobId=5611144&trk=jobs_seeking_view_job&goback=%2Evjs_5643461_*2_*2_*2_false_*2_*2 Vice President, Clinical Affairs ArmaGen- Greater Los Angeles Area Job Description Description: Vice President, Clinical Affairs Vice President, Clinical Affairs Job Purpose: Provide leadership in the design and execution of the clinical studies in the support of the corporate strategy Vice President, Clinical Affairs Job Duties: The Vice President, Clinical Affairs is a key position. She/he will lead the planning, development, implementation, execution and interpretations of the Company's Phase 1 and randomized controlled clinical trials (“RCT’s”) in support of the launch of new proprietary products. Handle all operational tasks for the clinical development of new drug candidates Serve as the primary interface for all of the company’s clinical development programs with regulatory agencies She/he will manage the Clinical Advisory Board to assure innovative design of the clinical studies. She/he will coordinate with the scientific staff, academic partners and Key Opinion Leaders (“KOL’s”), and senior management to ensure RCT strategies are aligned with corporate strategies. She/he will work collaboratively with research and development and regulatory affairs teams to develop strategies for the regulatory approval of clinical development candidates. Desired Skills & Experience Requirements 1) MD/Ph. D 2) 6+ years of experience in designing clinical trials 3) Pharmaceutical/biotech industry experience 4) Sound experience in clinical operations 5) Knowledge of and experience in regulatory affairs 6) Orphan drug development experience preferred Company Description www.armagen.com Additional Information Posted:May 3, 2013 Type:Full-time Experience:Not Applicable Functions:Other Industries:Biotechnology Job ID:5611144 ********************************************************************* http://www.linkedin.com/profile/view?id=9159873&authType=name&authToken=c-iQ&goback=%2Evjs_5643461_*2_*2_*2_false_*2_*2&trk=job_view Posted by Dan Boersma Clinical Research Recruiter at Valesta Senior Manager Clinical Affairs, Diagnostics Valesta Clinical Research Solutions- San Francisco Bay Area Job Description

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Senior Manager, Clinical Affairs, Diagnostics San Francisco Bay area Growing San Francisco Bay area diagnostics company has an immediate need to hire a full time Sr. Manager, Clinical Affairs. The Sr. Manager, Clinical Affairs will be responsible for leading clinical affairs, clinical trial study and evaluation and assisting in regulatory affairs. The position requires expertise working with FDA pre-marketing approval applications. Responsibilities Include:

Assist in the development, management and execution of clinical affairs related activities and assure compliance with domestic and international regulatory guidelines.

Lead communications with KOL physicians. Prepare clinical study protocols and plan, monitor and evaluate clinical studies.

Desired Skills & Experience Position Requires:

Master’s Degree (MD or PhD preferred) and strong diagnostics, molecular diagnostics and/or in vitro diagnostics clinical affairs experience.

Must have proven experience in statistics for problem solving. Must have strong knowledge in monitoring of clinical studies and Good Clinical Practice

(GCP). Travel requirement is up to 50% and includes both domestic and international travel.

Company Description Valesta Clinical Research Solutions (Valesta) is a leading provider of skilled clinical research professionals at all career levels for project-based, contract-to-hire, and direct hire opportunities. Our dedicated Account Executives thoroughly understand the industries they serve and offer resourcing solutions in specialized areas, such as clinical data, clinical monitoring, medical writing, biometrics, and regulatory affairs. In 2011, Valesta joined forces with the clinical research division of On Assignment forming a partnership that strengthened our ability to offer comprehensive resourcing services to our clients for both their domestic and international locations. Valesta offices are located in Mechelen and Wavre, Belgium; Madrid and Barcelona, Spain; and Den Bosch, Netherlands; with five branch offices in the United States, including California, Connecticut, Pennsylvania, North Carolina, and Illinois. Valesta Clinical Research SolutionsAdditional Information Posted:May 21, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Biotechnology Job ID:5643461 ******************************************************************** Posted by Vijay Ubhayaker, Principal Recruiter at Model N http://www.linkedin.com/jobs?viewJob=&jobId=5761806&trk=rj_em&ut=2zKSRHDACfrRM1 Director Product Marketing - Pharma Model N - San Francisco Bay Area Job Description Director, Product Marketing – Life Sciences Industry (Biotech, Pharma, Medical Devices) Model N, the leader in Revenue Management solutions, drives improved pricing, margin, and revenue performance through a powerful combination of best practices, highly configurable software applications, comprehensive services, and actionable analytics across the complete functional spectrum of pricing, contracting, rebating, sales, and marketing. Model N leverages its deep industry expertise to support the unique business needs of Life Sciences and Technology manufacturers in more than 50 countries. Global customers include: Boston

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Scientific, Bristol-Myers Squibb, Dell, Johnson & Johnson, Merck, Marvell, Maxim, Nokia, Novartis, Novo Nordisk, ON Semiconductor, STMicroelectronics, and Watson Pharmaceuticals. Summary: The Director of Product Marketing is responsible for product marketing for one of our top industries. In this position, you will work with the solutions group and product management to keep on top of relevant changes in our solutions and/or the industry you cover. You will translate your insights into new messaging and content that you’ll promote your content through events, campaigns, our own websites, and via social media. You’ll monitor the impact of these efforts and optimize your content to improve our demand generation results. You will also support sales teams with messaging and tools to properly position your solutions in the opportunities your content and demand generation efforts have helped create. It is the intent of this position that you quickly become the “go to” expert and spokesperson on your solutions and for Life Sciences. This position is based in our headquarters in Redwood Shores and reports directly to our VP of Marketing. Responsibilities:

Writing/Messaging: Message and position assigned solutions through succinct, compelling, well written and descriptive that get’s to the heart of the business value.

Industry Marketing: Drive marketing for the Life Sciences industry with Model N’s industry leading revenue management solutions.

Demand Generation/ Promotion: Work with a network of product strategy, management, and marketing professionals to devise strategies and tactics that will increase the size of the pipeline for Life Sciences.

Digital Story Telling: Develop “digital stories” using PowerPoint and other tools to deliver exceptional visuals that compliment exceptional content.

Sales Support: Support sales team members with optimal ammunition (read presentations, cheat sheets, solution briefs, etc) to properly position solutions and close opportunities. Serve as a company spokesperson or go-to thought leader.

Research: Leverage internal and external sources to find facts on our product and solutions or the supported industry/customer bases.

Qualifications: Years of Experience: 8 to 12 years of experience in product marketing, marketing

strategy, demand generation or promotion. MBA preferred. Industry: Marketing or product marketing experience in the Life Sciences highly

desired. Product Marketing Experience: Experience in driving Product Marketing for Analytics,

CRM, ERP, pricing, contracting, rebates or related software is highly desired. New Media/Web 2.0 Skills/Computer Skills: Able to use latest technology to create

compelling content that can be published via social media channels including blogs, video, Facebook, Twitter, YouTube, forums, wikis and social networks. Proficient in PowerPoint, Excel, Word, and Google apps.

Writing/Messaging: Required. Cross-Functional Management and Influencing Skills: Ability to credibly influence and

manage across, and up and down functions is vital. Multi-Tasking, Organization and Presentation Skills: Ability to be organized and keep

lots of diverse activities moving forward at the same time. Exceptional presentation skills. Strong presence with executive audiences.

Travel: 10-15% travel to events, meetings, and speaking engagements. Company Description Model N is the leading provider of Revenue Management and analytics solutions for Life Sciences and High Tech manufacturers. Over 40,000 users across 60 countries, ranging from the Fortune 500 to emerging businesses, use Model N's business process and analytics solutions delivered in the Cloud or on-premise to:

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* align and improve the revenue management process * gain actionable insights and drive strategic decisions across marketing, sales, and finance Additional Information Posted:May 17, 2013 Type:Full-time Experience:Director Functions:Marketing, Strategy/Planning, Business Development Industries:Management Consulting, Medical Devices, Biotechnology Job ID:5761806 ***************************************************************** Posted by Kim Crocker, SPHR http://www.linkedin.com/jobs?viewJob=&jobId=5704371&trk=rj_em&ut=1wkZcPX6ObrRM1 Program Manager – Strategic Marketing CardioDx- San Francisco Bay Area Job Description

Support product reimbursement strategy and payer relations/managed care sales through creation of sales tools, integration of internal/external clinical and economic data, healthcare economic value propositions, and related materials

Support long term strategic planning and portfolio development activities – perform market research for existing and pipeline products and partner with Business Development to analyze opportunities

Lead the definition of new products and upgrades to existing products by developing the customer requirements documents that is based on voice-of-customer and market research findings

Lead clinician advocacy development. Develop and strengthen relationships with clinician and patient advocacy organizations. Work with advocacy organizations to develop campaigns and programs to drive education, awareness, and adoption.

Partner with Managed Care and Provider Sales teams on Strategic Marketing initiatives Development of payer and provider messaging and coordination with product marketing

and public relations Development of product sales team training materials to support reimbursement and

managed care initiatives in the sales territories Desired Skills & Experience To perform the job successfully, the individual should demonstrate the following competencies:

Strong analytical skills with ability to synthesize complex or diverse information, collect and research data

Outstanding written and oral communication skills Proven track record in creating and implementing strategic programs for clinicians,

patients to drive awareness, education, adoption, and advocacy Passion for and aptitude in assessing products, customers, market dynamics and

competitive environment High degree of professionalism at work combined with strong ownership and

accountability of projects, deliverables, and due dates Self-motivated, resourceful, self-directed and can work independently on projects using

good judgment with minimal direction Ability to work as a team member and is respectful of other’s opinions that may be

different from one’s own Must be able to multi-task and adapt to a work environment that can be dynamic and

changing Strong interest in genomic testing and/or molecular diagnostics

Education/ Work Experience Desired

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Bachelor’s degree with at least 3-5 years of work experience in product marketing, strategic marketing, managed care marketing and/or healthcare market research

Bachelor’s Degree required, MBA or Master’s Degree in Public Health, Public Policy, or Economics strongly preferred

Experience working with managed care sales and/or provider sales Travel Required

Position may require travel 20-30% of the time Company Description CardioDx is a cardiovascular genomic diagnostics company located in Palo Alto, CA. CardioDx develops clinically validated genomic tests to aid in assessing and tailoring care of individuals with cardiovascular disease, including coronary artery disease (CAD), cardiac arrhythmias, and heart failure. Additional Information Posted:

May 13, 2013 Type:

Full-time Experience:

Mid-Senior level Functions:

Marketing Industries:

Biotechnology Job ID:

5704371 ********************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5317955&trk=rj_em&ut=3zXCOhGhoDrRM1 Life Sciences Industry Marketing Principal EMC- Pleasanton, CA or Boston, MA (San Francisco Bay Area) Job Description The Life Sciences Industry Marketing Principal will support the development and execution of the go-to-market industry strategy and plan for the EMC Information Intelligence Group (IIG). As part of the IIG Product & Solutions Group (IPSG) Marketing team, this position will be responsible for solution marketing-related efforts for Life Sciences on a global basis. By delivering industry marketing expertise and in-depth insights and analysis of our market, trends and opportunities, this role will play a key role in building market awareness, developing messaging, executing solution launches, driving field and partner enablement, and other programs and activities that increase market share and impact overall revenue growth. Reporting to the Director of Market Development for Life Sciences, the role will also work closely with Product/Solution Development, IIG Corporate Marketing, Sales, and other cross-functional teams across the business to ensure full alignment and effective integration of EMC resources, programs, and activities. Desired Skills & Experience Principal Duties

Collaborate with the Director of Market Development in developing, managing and implementing a cohesive industry business strategy and go-to-market plan for Life Sciences.

Develop and educate the business on compelling, differentiated industry positioning and value propositions for existing and new solutions.

Work with key stakeholders to deliver the IIG Life Sciences portfolio strategy across products, solutions, services, and partners.

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Create industry-specific content to create market awareness and demand generation campaigns/programs. Develop customer- and partner-facing assets for sales and marketing, including industry presentations/webinars, industry/solution overviews, sales presentations, playbooks, training materials, customer cases studies, and whitepapers.

Analyze market research and competitive trends to inform market segmentation, strategies, programs, new solutions and enhancements to the IIG industry portfolio.

Participate in or facilitate the participation of IIG in industry and EMC-sponsored events, including presentations, analyst briefings, press releases, tradeshow booth support, etc. Serve as IIG spokesperson and industry expert with the analysts, industry trade press, partners, and other external initiatives.

Ensure a metrics-driven approach to all industry marketing activity. Critical Hiring Criteria Skills

Knowledge and experience within the Life Sciences industry A strong understanding of and ability to clearly articulate industry challenges, trends

and market needs for enterprise content management or information management Ability to work well and manage by influence in a matrix organizations, with the ability

to cut through multiple, differing perspectives and opinions in order to execute successfully

Exceptional writing and verbal communication skills with ability to distill disparate information and perspectives into concise, relevant and impactful marketing messages and content

Team-focused, with logistical and creative skills, have a keen eye for detail, and dedication to the success of the team and the organization.

Must be hands-on, self-starter who can manage projects/deadlines/priorities, as well as do the work required to get things done

Education Required Bachelors (Non -Technical) MBA preferred, but not required

Experience Required 10+ years relevant experience in a global enterprise technology company

Company Description EMC Corporation is the world leader in products, services and solutions for information management and storage. We are a trusted provider of information infrastructure, helping organizations of every size around the world keep digital information protected, secure, and continuously available. We are among the 10 most valuable IT product companies in the world. We pride ourselves on doing what is right and on putting our customers’ best interest first. We are EMC, where information lives. EMC is an Equal Employment Opportunity employer that values the strength diversity brings to the workplace. EMC does not accept unsolicited Agency Resumes. EMC will not pay fees to any third party agency or firm that does not have a signed "EMC Agency Fee Agreement". Additional Information Posted:April 30, 2013 Type:Full-time Experience:Mid-Senior level Functions:Product Management, Marketing Industries:Marketing and Advertising Job ID:5317955 **********************************************************

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http://www.linkedin.com/jobs?viewJob=&jobId=5657923&trk=rj_em&ut=3Ud_LQxhUCrRM1 Sales Manager - Life Science and Diagnostic Tools Fluxion Biosciences- San Francisco Bay Area Job Description Fluxion is currently looking for an experienced Sales Manager to lead the commercialization effort for the recently-launched IsoFlux System. This position is an excellent opportunity for an experienced sales professional to take on a leadership role in the rapid commercial growth of a new instrumentation platform that will have a major impact in the field of cancer diagnostics. The successful candidate will be a natural ‘closer’ and contribute to both sales and business development activities as well as serving as a sales liaison to the project and management teams. This high visibility position will focus on the commercial adoption of the IsoFlux System within university, research center, biopharma, and clinical lab sites. The ideal candidate will have a background in sales and business development in the life science tools and diagnostics industry. A strong, verifiable track record of closing sales opportunities and exceeding projections is imperative for this role. This is a consultative sales role – the ideal candidate will able to maintain a high degree of technical knowledge and interact with high level customers across a variety of institutions. Location: This position will be based out of Fluxion’s South San Francisco, CA headquarters. Consideration will be made for exceptional candidates that are based out of other key geographies. The Sales Manager will:

Maintain responsibility for hitting the sales targets of the IsoFlux System, both in the US and internationally

Manage the sales pipeline by accurately tracking sales opportunities according to customer segment and progression towards closing

Pursue sales prospects coming from a variety of sources (marketing and business development activities) by offering sales presentations, technical consultations, evaluations, etc.

Work closely with the product and technical teams (field and in-house application scientists) to address customer inquiries and product evaluations

Conduct negotiations surrounding purchase orders, placements, etc. and ensure timely closing of opportunities

Analyze the key metrics surrounding progression of sales opportunities and be prepared to make recommendations to optimize the sales cycle and product positioning

Work closely with Fluxion’s network of international distributors to maintain sales targets in their geographies and close individual sales opportunities

Identify new areas of commercial growth for the existing IsoFlux product and make recommendations for future product development

Represent the product and company at US and international conferences and trade show exhibits

Identify and pursue sales and business development channels beyond single institution sales, including: OEM, private label, CRO/Reference Lab, and Dx partnerships

Desired Skills & Experience This job will require the following attributes:

Bachelors level degree in the biological sciences or engineering (MS, MBA, or Ph.D. preferred)

A MINIMIUM of 5 full years of post-graduate experience with a life science tools or diagnostics company

A MINIMUM of 3 full years of experience in a direct sales role for instrumentation / capital equipment (>$10K) with ownership of territorial or product sales number

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Additional experience in marketing, business development, and/or product development preferred

Direct experience as a sales professional with a company in any of the following areas: o Oncology diagnostic instrumentation o Biomarker testing / diagnostics o Sequencing instrumentation or reagents o qPCR / dPCR / multiplexed PCR instrumentation or reagents o Pathology / microscopy instrumentation o Ability to work both independently and within the team structure, good

teamwork attitude a must o Ability to work in a fast paced and changing environment o Flexible and quickly adaptable to changing priorities o Excellent written and oral communication skills and meticulous record keeping o Experience with sales CRM platforms (Salesforce preferred) o Moderate travel (20-40%) required to cover customer visits, conferences, and

international distributors Company Description Fluxion Biosciences is a rapidly-growing bioanalytical tool company that is addressing critical needs in the pharmaceutical, biotech, diagnostics, and life science research markets. We are looking for individuals who will thrive in a fast-paced environment and can make meaningful contributions to the development and commercialization of our line of products for cellular analysis. Fluxion offers competitive salary, stock options, and a comprehensive benefits package (health, dental, vision, FSA, and more). Additional Information Posted:May 8, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development Industries:Biotechnology, Medical Devices, Research Job ID:5657923 ******************************************************** Posted by Ashley Moore Senior In-house Clinical Research Associate Pharmascent, a division of The Ascent Services Group- San Francisco (San Francisco Bay Area) Job Description Pharmascent is hiring a Senior In-house Clinical Research Associate in San Francisco, CA. Please contact Ashley for questions and application at 708.428.6340 or amoore@pharmascent.com Job Location: San Francisco, CA Responsible for the planning, implementation, monitoring and site management of clinical studies Candidate may be responsible for training of CRAs/CRO in conduct of such visits Works closely with the Clinical Program Manager Responsibilities may include managing clinical supplies, working with/managing CROs, recruiting investigators, organizing investigator meetings, setting up internal central systems as needed, assist in writing study protocols, final study reports, SOPs, expedited/annual safety reports, and designing and implementing CRF's. Duties also include liaison activities with multiple project group members. Desired Skills & Experience Job Requirements: Requires a BS, RN, or RPh and 5+ years of related clinical experience. Knowledge of Phase I through III Clinical Trials.

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Must have in-depth experience in conducting pre-study, site-initiation, monitoring, and closeout visits. Multitasking, ability to work independently, excellent interpersonal and communication skills are critical, as is flexibility and strong attention to detail. Ability to travel when required This is a very hands-on position in a very small start-up clinical group within a mid-size biotech company ***APPLY TODAY OR REFER A FRIEND! We offer a terrific referral bonus! Ashley Moore, Clinical Recruiter amoore@pharmascent.com 708.428.6340 Pharmascent, A Division of The Ascent Services Group, specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry. Company Description ***PharmAscent specializes in contract staffing, contract to hire, direct hire search and small project consulting services for the FDA-regulated industries. Our team has over 40 years of combined experience in identifying top notch professionals for direct hire and contract staffing needs. We understand that “people” are the key to a successful organization. Our goal is to deliver innovative people through proven best practices and effective resource optimization. Feel free to visit us at... www.pharmascent.com Pharmascent, a division of The Ascent Services GroupAdditional Information Posted:May 29, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Biotechnology Referral Bonus:YES! Ask me! Job ID:5875887 ********************************************************** Posted by Ashley Moore Clinical Trial Manager Pharmascent, a division of The Ascent Services Group- San Francisco (San Francisco Bay Area) Job Description Pharmascent is hiring a Clinical Trial Manager in the San Francisco, CA Area. Please contact Ashley for questions and application at 708.428.6340 or amoore@pharmascent.com Major Responsibilities/Accountabilities: The Clinical Trials Manager will work under the supervision and guidance of the Director, Clinical Operations to ensure completion of the following clinical drug development activities: Essential functional duties of the position · Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments. · Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct. · Has had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program. · Independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms. · Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed. · Leads study management team meetings and teleconferences with study vendors. · Manages study-specific CROs and vendors and contract CRAs as appropriate.

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· Performs monitoring of sites as required by needs of project with minimal guidance or supervision. · Attends scientific meetings as a representative of clinical operations team. Other responsibilities/accountabilities (secondary functions) · Adds insight regarding evaluation and selection of CRO’s, contractors and other outside vendors. · Coordinates efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other departments as appropriate. · Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance. · Uses well-developed problem-solving skills to address needs of program and may provide guidance to other lower level personnel. Desired Skills & Experience Job Requirements: Knowledge/Skill Requirements: · BA/BS in science-related field with a minimum of 4 years experience as a CRA or CRA/CTM combination of relevant related work experience. · Excellent written and verbal communication skills required. · Demonstrated thorough understanding of FDA regulations and GCP. · Well-developed and strong problem solving skills. · Exceptional interpersonal skills with demonstrated successful team participation. · Demonstrated skill in managing multiple tasks simultaneously, with attention to detail. · Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc. Ability to travel important as the position could require approximately 25% time spent in business travel. ***APPLY TODAY OR REFER A FRIEND! We offer a terrific referral bonus! Ashley Moore, Clinical Recruiter amoore@pharmascent.com 708.428.6340 Pharmascent, A Division of The Ascent Services Group, specializes in nationwide direct hire and contract placement for the Pharmaceutical and Biotechnology industry. Company Description ***PharmAscent specializes in contract staffing, contract to hire, direct hire search and small project consulting services for the FDA-regulated industries. Our team has over 40 years of combined experience in identifying top notch professionals for direct hire and contract staffing needs. We understand that “people” are the key to a successful organization. Our goal is to deliver innovative people through proven best practices and effective resource optimization. Feel free to visit us at... www.pharmascent.com Additional Information Posted:May 29, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Biotechnology Referral Bonus:YES! ASK ME! Job ID:5876519 ********************************************************** Posted by Erin Krolikiewicz , Principal Sourcing Consultant at Genentech Apply on company website

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Senior Clinical Trial Manager Genentech- San Francisco Bay Area Job Description Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our San Francisco, California headquarters: Senior Clinical Trial Manager Responsibilities: The Genentech Research and Early Development (gRED) Senior Clinical Trial Manager (Senior CTM) provides leadership to one or more global Study Teams within an early development program(s). The Senior CTM is accountable for activities ensuring high quality deliverables are within budget and timelines. The candidate will independently lead cross-functional Study Team within Clinical Operations with minimal oversight from the CPL. He/she is accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets. The candidate is responsible for vendor selection and management including CRO, IVRS, central lab, imaging vendor. The candidate will provide input to the program budget and is accountable for managing overall study budget. He/she will identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate. The successful candidate will partner with CPL to develop and/or present at project teams and management review bodies. He/she will ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines. The candidate will delegate and oversee study activities assigned to Clinical Operations as applicable. These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual. Desired Skills & Experience Requirements: A Bachelor’s degree or equivalent (scientific or healthcare discipline preferred) and at least six years’ study management experience in clinical and drug development are required. Working knowledge of international regulatory and ICH GCP guidelines is required. The candidate should be highly experienced in managing early development phase clinical studies and generally experienced in clinical research/development Willingness to travel domestically and internationally, and work across cultures is required. Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. To apply for this job, visit https://roche.taleo.net/careersection/10002/jobapply.ftl?lang=en&job=00408482&src=JB-12480 Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer. Company Description At Genentech, we are passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

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Additional Information Posted:May 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Biotechnology Job ID:5719138 _____________________________________________________ Posted by Shawn Tang, Principal Staffing Consultant at Genentech Sr. Clinical Trial Manager, gRED Genentech- US - California,South San Francisco (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Purpose: The Genentech Research and Early Development (gRED) Senior Clinical Trial Manager (Sr. CTM) provides leadership to one or more global Study Teams within an early development program(s). The Sr. CTM is accountable for activities ensuring high quality deliverables are within budget and timelines. Primary Accountabilities and Responsibilities: • Independently lead cross-functional Study Team within Clinical Operations with minimal oversight from the CPL • Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets • Responsible for vendor selection and management including CRO, IVRS, central lab, imaging vendor • Provide input to the program budget and is accountable for managing overall study budget • Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate • Partner with CPL to develop and/or present at project teams and management review bodies • Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines

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• Conduct protocol and site feasibility assessments • Provide drug supply assumptions to clinical planning team • Delegate and oversee study activities assigned to Clinical Operations as applicable • Provide support, mentoring, and study-specific training to Clinical Operations staff • Network and share best practices with colleagues to ensure optimal efficiency and consistency in Clinical Operations • Participate in initiatives and/or activities as assigned These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work. Different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual. Who You Are Minimum: • 6+ years study management experience in clinical and drug development • Bachelors degree or equivalent required (scientific or healthcare discipline preferred). • Working knowledge of international regulatory and ICH GCP guidelines Experience, Skills, Knowledge: • Highly experienced in managing early development phase clinical studies and generally experienced in clinical research/development • Effective leadership of cross-functional teams • Extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studies • Demonstrated experience in various therapeutic areas • Familiar with global trial requirements • Demonstrated creativity and innovation to support projects and initiatives • Excellent planning and organizational skills • Flexible and solution focused • High level of initiative and ability to work independently • Strong analytical skills • Strong customer focus

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• Highly effective verbal and written communication skills in English Other (e.g. Travel): Willingness to travel domestically and internationally, and work across cultures. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. Additional Information Posted:May 23, 2013 Type:Full-time Experience:Associate Functions:Research Industries:Biotechnology, Pharmaceuticals Employer Job ID:00408482 Job ID:5814460 ************************************************************* Apply on company website CLINICAL RESEARCH ASSOCIATE Abbott- Santa Clara, US-CA (San Francisco Bay Area) Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. PRIMARY JOB FUNCTION: Responsible for implementing and maintaining the effectiveness of the quality system. The clinical research associate (CRA) designs; implements; and monitors clinical studies of new and modified in vitro diagnostic products. Ensures that the clinical studies are designed to validate product performance claims and support the products’ intended use. Prepares clinical data reviews and data summaries. Participates in the preparation of regulatory submissions and international registration packages. In general; the CRA performs responsibilities and task under the direction of a SCRA or CPM. CORE JOB RESPONSIBILITIES: Responsible for implementing and maintaining the effectiveness of the quality system. Implements and maintains the effectiveness of the Quality System. Complies with all policies; established procedures; and regulations related to clinical research. Actively participates as a member of the cross-functional project team. With direction performs the following: - Assesses data generated by R&D/Business Teams.

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- Prepares design validation plans. - Prepares documents for clinical studies. - Identifies and qualifies clinical investigators and clinical sites. - Proposes and negotiates budgets for clinical studies. Initiates payments to sites. - Obtains and reviews all required essential documents necessary for study initiation. - Reviews data; prepares and presents clinical data reviews and data summaries. - Responds to audits and data queries. - Prepares the clinical sections of regulatory submissions and international registration packages. - Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study. Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments. Arranges for and assists in standard Statistical Support with the collection and statistical analyses of clinical data. Monitors standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights; safety; and welfare is protected; ensures data integrity through completeness; accuracy; and legibility. Prepares and reviews product labeling and promotional materials. Conducts standard pre-study; initiation; interim; and close-out monitoring site visits and completes site visit reports.; Initiates standard clinical studies and provides for investigator and staff training. Maintains accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports to keep management and team informed. Supports publication or presentation of clinical data in professional journals or meetings.; Maintains professional; product; and market expertise via independent reading; networking; and training.; Implements all policies; established procedures; and regulations into daily operations as appropriate. Develops professional; expertise via professional and educational opportunities. Assumes responsibility for attending training sessions; presentations; and continuing education sessions. Works with assistance to prepare publications; abstracts; or presentations for professional meetings.; Contributes to goal setting. Takes responsibility for achieving results. Honors commitments. Self-motivated. Accepts and completes all management-directed work assignments such as clinical assignments; travel; and other tasks.; Demonstrates good basic writing skills. (i.e. clear; concise; effective; and well-organized) Demonstrates good presentation skills. (i.e. clear; concise; effective; and well-organized); Tries to understand changes in work tasks; situations; and environment as well as the logic or basis for change.

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POSITION ACCOUNTABILITY / SCOPE: Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates. Early identification of unsatisfactory results; operations; or specific problems allows immediate action to be taken by appropriate groups. Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project. Participates in professional activities in the US and/or Internationally. Desired Skills & Experience - Bachelor's degree - B.S in biological sciences or medical specialty preferred. - Preferred knowledge of regulations and standards (GCP) affecting IVDs and Biologics. - Other: Clinical Laboratory certification (MT; ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable. - Minimum of 3 years clinical related experience - Preferred site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience. Additional Information Posted:May 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Analyst, Engineering, Research Industries:Biotechnology, Pharmaceuticals, Research Employer Job ID:130000043N Job ID:5700452 ********************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=5878144&trk=eml-anet_dig-b_premjb-ttl-cn&ut=1IOJUlSV0nrRM1 Manager, Clinical Relations West Coast University- Los Angeles (Greater Los Angeles Area) Job Description West Coast University is an industry leader and we are currently seeking a Manager of Clinical Relations for the Los Angeles region. This is an outstanding opportunity for a dynamic and experienced professional to join a growing university as we expand our academic programs in healthcare and related fields. Summary: Reporting to the Executive Director, University Relations with an indirect reporting relationship to the Campus Dean of Nursing, works to build strategic marketing relationships for advancement of West Coast University’s mission. Contracts with clinical partnerships, assists with faculty recruiting, assists placement teams and in tandem with Admissions Business Development Representative, works to obtain cohort site contractual agreements. Represents West Coast University to the community, providing and maintaining a positive image of West Coast University to the community. Desired Skills & Experience Qualifications:

Bachelor’s degree in Nursing, marketing, sales, business administration or related field required

Minimum of two (2) to three (3) years experience working with or in clinical sites, placing students and coordinator related documents preferred

Knowledgeable of medical community and established relationships with professional memberships

Clinical nursing background preferred Two (2) to three (3) years experience as nursing faculty preferred

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Current driver's license required Knowledgeable of education standards such as ACICS, BRN, CCNE, WASC and other

accreditation standards preferred Proficient skills and experience in Microsoft Office computer software systems that

includes word processing, spreadsheets, and presentations Your daily reward will be the personal satisfaction of having a chance to make a difference to yourself, your team, and to a group of students who expect an outstanding education. Full time associates are eligible for an exceptional benefits package which includes: Health, dental and vision plan Vacation, sick and holiday schedule Tuition Reimbursement 401(k) Plan with employer match Flexible Spending Account Long/short term disability and more For more information about our University and to apply for this career opportunity, please visit our website: www.westcoastuniversity.edu. West Coast University is proud to be an equal opportunity employer, and we seek candidates who desire to work in and serve an ethnically-diverse population. Company Description West Coast University (WCU) is a private university with the singular focus of educating health care professionals. Across our three Southern California campuses, we offer undergraduate degrees in nursing and graduate degrees in nursing and health care management. Our Orange County campus offers one of only four Bachelor of Science Degrees in Dental Hygiene in all of California. Our newest campus in Dallas, Texas offers undergraduate degrees in nursing. In addition to West Coast University’s modern campuses, technologically advanced Simulation Centers and no-cost community Dental Hygiene Clinic, WCU offers a global studies opportunity for top nursing students. With the university’s student-centric philosophy and commitment to creating a learning environment that supports academic excellence, WCU prepares graduates for a career they love that meets the needs of the community and demands of the market. For list of open positions, please visit the “Employment Opportunities” section of our website: http://www.westcoastuniversity.edu Specialties A health care education that is ahead of the curve Undergraduate degrees in nursing and dental hygiene and graduate degrees in nursing and health care management Technologically advanced Simulation Centers No-Cost community Dental Hygiene Clinic (Orange County Campus) Student-centric philosophy Additional Information Posted:May 29, 2013 Type:Full-time Experience:Mid-Senior level Functions:Management Industries:Education Management Job ID:5878144 ******************************************************** Contact Tom Graham Regulatory Practice Manager

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South Twin Executive Search 1064 Gravel Road Webster, NY 14580 Direct Office: (585) 216-1357 Email: tom@southtwinsearch.com Website: www.southtwinsearch.com TITLE: RA Sr. Manager / Assoc. Director #2 LOCATION: San Francisco Bay Area COMPANY PROFILE: Founded over 20 years ago, this growth opportunity is with one of the most buzzed about new oncology companies o n the West Coast! In addition to a much anticipated new product approval in 2013, this firm has one of the stealthiest pipelines in their therapeutic field. If you’re looking to be among the founder’s core group of talent for the long haul, this is definitely one to take a look at! RA Assoc. Dir. / Director CMC #3 LOCATION: Pacific Northwest COMPANY PROFILE: This is one exciting new CNS company! With two products currently in Phase III trials and its first proprietary product approval anticipated in summer of 2013, this is a chance to land a leadership role in one of the hottest start-ups on the West Coast. In addition, this 20 year old firm has seven follow up compounds currently in development so if your goal is to be a significant contributor with a dynamic enterprise and be recognized for your success, this is the opportunity for you!

___________________________________________________________________ RA Assoc. Director / Director #4 LOCATION: San Francisco Bay Area COMPANY PROFILE: Founded over 20 years ago, this growth opportunity is with one of the most buzzed about new oncology companies on the West Coast! In addition to a much anticipated new product approval in 2013, this firm has one of the stealthiest pipelines in their therapeutic field. If you’re looking to be among the founder’s core group of talent for the long haul, this is definitely one to take a look at!

___________________________________________________________________ RA Assoc. Director CMC #5 LOCATION: San Francisco Bay Area COMPANY PROFILE: Not as new but every bit as innovative, this giant is among the most recognized pharmaceutical brands and has stayed about as stable as they come for nearly one and a half centuries! Even though they are a renowned global leader across multiple therapeutic areas, this company remains employee centric and maintains a dynamic company culture that many start-ups find challenging. If landing with a “steady Eddie” but still consistently on the cutting edge fits your style, this is both a company and geography you’ll leave your heart in.

___________________________________________________________________ QC / QA Manager #6 LOCATION: San Diego Area COMPANY PROFILE: This is one of those opportunities that have come along at the right time and at the right place! This mid-sized, respected diagnostic company has been recently acquired by a European enterprise whose goal is to become the #1 firm in the U.S. for its specialty therapeutic area. This highly visible role reports directly to the COO of the company and has the real potential to

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grow into any level role in between! Grow with a prospective leader as you take in the sunshine as well as the beach in one of the most desirable locales in America! ********************************************************** Posted by Lisa FitzGerald, President, ExecQuest LLC - Recruiter experienced in Medical Writing & Communications, Medical & Clinical Affairs Senior Medical Writer, Manager or Sr. Manager Regulatory Writing ExecQuest- Remote or S. California (Greater Los Angeles Area) Job Description Sr. Medical Writer, Manager or Sr. Manager – Regulatory Writing – CA or Remote Work-From-Home Job Summary: Sr Writer and Manager are regulatory wriiting positions requiring 2-3 years experience, while the Sr. Manager is a lead writing position (no initial reports but ability to lead teams/supervise others and may have reports in the future) requiring significant years of experience and previous lead writer experience on submission documents. The company is a highly successful W. Coast Pharmaceutical Co. with locations in the greater Los Angeles area & in S. San Francisco. At Senior Manager level, the position can base out of either CA office (relocation provided) or can work from a remote home office within the U.S. Responsibilties: · Independently write clinical study reports, Investigator Brochures, Summaries of Clinical Efficacy, Summaries of Clinical Safety, Summaries of Clinical Pharmacology, Summaries of Biopharmaceutics, Clinical Overviews, Tables of All Studies, briefing documents, Risk Management Plans, and Response to regulatory questions · Prepare and manage the development of other regulatory documents and CTD sections, as appropriate (Modules 2, 3, 4 and 5 for CTD, Risk Management Plans, Responses to regulatory agency questions, protocols, statistical analysis plans, FIH documents) · Formally review and approve all regulatory documents · Serve as the functional area representative and lead (at Sr. Mgr. level) on product teams · Provide functional area input for Global Regulatory Plans, Global Development Plans, and team goals · Responsible for study timelines for regulatory documents · Participate in development of regulatory submission strategy · Manage medical writers (includes career development, conducting performance reviews, providing coaching and guidance) · Identify, assess, and oversee individual contractors, freelance, and temporary writers · Keep abreast of professional information and technology through literature, symposia, and conferences · Provide innovation for improving departmental processes · Provide expertise and guidance on document design and principles of good medical writing to the department and product teams · Work with medical writers to establish project priorities, and oversee decisions · Assist with budget Desired Skills & Experience Preferred Qualifications:

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· 2+ years of directly relevalnt experience for Sr Medical Writer, 3+ years for Manager, 8+ years of experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs) for Sr. Manager. · Advanced scientific degree preferred, Bachelor's degree in a scientific discipline considered. · Management skills/ability to supervise, ,mentor, train, direct/delegate, develop and others (at Sr. Manager level) – and drive for results Company Description The company is a highly successsful pharmaceutical company with locations in the greater Los Angeles area and S. San Francisco. The position (at Sr. Mgr. level) can be a staff/full-time/remote work from home position. At Manager and Sr Writer levels, the preference is the position base from the CA office but there may be flexibility depending on experience. Additional Information Posted:May 8, 2013 Type:Full-time Experience:Mid-Senior level Functions:Writing/Editing Industries:Pharmaceuticals Compensation:90-140K, bonus, stock, generous benefis Employer Job ID:CAMgrsrMgr Job ID:5654597 ******************************************************** Apply on company website Manager/Sr Manager Compliance Operations Medivation- San Francisco Bay Area Job Description Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publically traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Manager/Sr. Manager Compliance Operations. The Compliance Operations Senior Manager is responsible for supporting and collaborating with Medivation's Corporate Compliance Office and legal team to ensure Medivation's adherence to all applicable federal and state laws as well as all policies and regulations related to Medivations business practices. Included in these responsibilities are the management of Medivation's transparency initiatives (Sunshine Act + various state requirements), coordination of training activities with the commercial Training group, serving as a liaison to the Marketing, Sales and Medical Affairs teams as necessary, participating in policy development and amendments, and management of technology related compliance initiatives. Additionally, the role supports all field and corporate personnel in health care professional interactions including system support, inquiry support and customer support. Essential duties & responsibilities but not limited to the following: Operations/Reporting:

Responsible for timely and accurate submissions of all transparency reporting Quarterly data review and issue resolution Final report (various state and federal) verification Interfacing with vendor to ensure completeness, accuracy, and timeliness of data Responsible for ongoing management of resources (internal or external) dedicated to

transparency reporting

Partnership with IT in implementing systems to support Medivation Compliance related technology initiatives

Lead or participate in cross -functional data initiatives with customer and peer groups. (Sale Ops, IT, Marketing, Sales, Legal)

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Provides day-to-day operational support for senior Commercial Ops staff in the following areas:

Ongoing status of all transfer of value data Communication development for all compliance related activities Management of training and certification processes Training material development Auditing of field activities Sunshine Act Preparedness and Operational Management

Field Support: Provide ongoing updates on compliance with policies related to transparency,

institutional requirements, data, etc… Triage and address issues submitted Assist with resolution of transparency related discrepancies Provide clarifications related to policy

Vendor Management – (CIS,...) Manage Vendor and deliverables to ensure timely and accurate transparency reporting Responsible for budget allocation of vendor product or services. Management of the Statement of Work by vendor. Supervision of deliverable and timelines. Coordinate on-going training and client site visits.

Desired Skills & Experience Requirements

3-7 years biotech / pharmaceutical experience in pharma compliance/sales ops/data management or commensurate legal experience plus industry experience

Supervisory or management experience desireable Experience with industry data and caveats Experience working with field teams and commercial organizations Ability to assemble a wide variety of data, translate it into information, and

communicate a summary of the information. Strong communication skills, strong analytical and problem solving skills, and

intermediate computer skills. Computer skills should include but not be limited to Excel, Word, and Power point. Ability to resolve complex issues with the sales force. Ability to work effectively within a fast paced team environment is essential.

Specific product knowledge in the pharmaceutical or biotechnology industry is a plus. Education:

Bachelors Degree is preferred (general business, economics, mathematics, statistics, or industry-specific, such as health sciences, disciplines are a plus)

MBA or other related graduate-level degree is a plus Company Description Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publically traded biopharmaceutical company located in San Francisco. Medivation is focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation’s goal is to transform the treatment of these diseases and offer hope to critically ill patients and their families. With the approval of Xtandi (enzalutamide) capsules in late August and the early September product launch immediately following, Medivation is in the process of building and developing a world-class workforce to take the company to the next strategic level. Additional Information Posted:May 3, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Biotechnology, Pharmaceuticals

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Job ID:5610712 ******************************************************* Posted by Marian Wong, Staffing Consultant at Bio-Rad Senior Product Manager Bio-Rad Laboratories- SF Bay Area (San Francisco Bay Area) Job Description This position will support the Lab Separations Division within Bio-Rad Laboratories. Specific duties required include the following:

Maintain knowledge of markets, customer needs, and competitive landscape. Assist in creating strategic global marketing plans including forecasts, budgets, market

research, situation analysis, product portfolio management, product positioning and elements of marketing mix (product, price, promotion and distribution) to create competitive advantage.

Execute marketing strategy to achieve business goals; recommend direction and product positioning for assigned product/lines.

Coordinate efforts with engineering, R&D, manufacturing and sales to support and enhance products.

Measure business performance against expectations, report on results, and adjust strategies and tactics to accomplish business goals.

Support worldwide business growth strategies (short and long-term) with clearly defined goals, objectives, critical success factors, timelines, budgets and action items.

Ensure international sales and marketing teams' needs for sales support material and training are met.

Travel worldwide to obtain direct knowledge of internal and external opportunities. Desired Skills & Experience

BS/BA in Life Science required (MS or PhD desired). Strong understanding/experience with Protein Analysis including, electrophoresis,

western blotting and mass spectrometry applications. 5 years of marketing in the life sciences. Must have a professional manner, and a demonstrated ability to work collaboratively

within cross-functional teams. Ability to ask open questions and have strong listening skills. Ability to work effectively on teams by working toward consensus but also highlighting

important issues and findings. Requires demonstrated planning/organizational skills. Executes sound judgment, analyzes issues, thinks strategically, creatively, and uses

innovative ideas. Demonstrates exceptional problem solving, decision-making, conflict management,

change management and negotiating skills. Exceptional public speaking skills needed to represent corporation at external meetings,

conferences and organizations. Able to present high level information for multiple audiences, including scientist,

executives, and laymen. The candidate will travel up to 25%, both domestically and internationally. Proficiency in the following required: Microsoft Word, Excel, and PowerPoint.

Company Description About Bio-Rad: Bio-Rad Laboratories has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Founded in 1952, Bio-Rad has a global team of more than 6,800 employees and serves more than 85,000 research and industry customers worldwide through its global network of operations. Throughout its existence, Bio-Rad has built strong customer relationships that advance scientific research and development

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efforts and support the introduction of new technology used in the growing fields of genomics, proteomics, drug discovery, food safety, medical diagnostics, and more. Career Opportunities: Bio-Rad offers a world of career opportunities in a variety of professional disciplines. Whether your talents lie in software development, laboratory science, instrument design engineering, chemical and instrument manufacturing, sales, support, or administration, you can find a place on our worldwide team and enjoy a challenging career in one of today's most dynamic industries. Additional Information Posted:May 31, 2013 Type:Full-time Experience:Mid-Senior level Functions:Product Management, Marketing, Sales Industries:Biotechnology Job ID:5908976 ****************************************************************** Posted by Kimberly Scholz To apply for this position click here: https://home.eease.adp.com/recruit2/?id=4343741&t=1 Business Development Associate (Inside Sales) Pharmatek is looking for an energetic and experienced Business Development Associate (Inside Sales). This role supports strategic marketing and tactical business development initiatives for the Company. Key objectives include data collection, market research, fielding incoming inquiries, screening and developing lead sheets, cold calling, initial customer qualification, and general support for the outside Business Development team. ****************************************************************** https://jobs.smartbrief.com/action/listing?listingid=ACEBDE15-4B17-435C-9BAE-3F5564555A01&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Mgr, Global HCP Transparency Edwards Lifesciences Job Description This role leads the preparation and submission of all applicable reports for external and internal submission, he/she is a key contributor in developing a global HCP Transparency process, structure and associated tools to ensure compliance with external HCP regulatory requirements and internal policies. In addition, this role leads the HCP spend data reconciliation and audit process for accuracy and completeness. Responsibilities:

Responsible for management of compilation and analysis of data necessary to satisfy the Company’s state, federal and internal reporting requirements

Lead the preparation and submission the following reports to the applicable state or federal agency by appropriate timeline:

Federal Sunshine Act reporting for all US-based doctors Vermont and Massachusetts State HCP Reporting, plus any additional states Annual Voluntary HCP Reporting (externally posted on EW website) Quarterly Global Executive HCP Reporting (internal reports) Create and help maintain Edwards’s assumptions document reflecting all business

decisions and assumptions made by EW when interpreting laws and regulations for purposes of tracking spend and filing disclosure reports

Create, manage and maintain an upward certification process to secure sub-certifications for state (MA and VT) and federal reports from appropriately defined stakeholders prior to finalization and submission

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Project Manage the Global Data Steward process including managing delivery by third party vendors and lead the US HCP request fulfillment process

Create and manage a formal HCP Transparency monitoring and reconciliation program and present finding (s) to Global Transparency leadership

Draft responses to any inquiries from government entities, regulatory authorities, HCPs and other third parties relating to the disclosed report or underlying data discrepancy.

Work closely with the Sr. Director Global Transparency, PM Global Transparency and other Compliance members to ensure systems, templates and policies are clearly defined and accurate to capture HCP spend data and contribute to system/process enhancements

Assist in development of policies and processes related to aggregate spend and HCP reporting

Required Skills: Ability to quickly learn, understand, and implement the new regulations around Federal

Sunshine Act Reporting, and the future changing landscape for all state, federal and global regulations

Ability to create accurate reporting in the HCP area Strong project management skills and ability to manage a cross functional team

including external vendors Strong understanding of process flows through transactional systems, and ability to

recommend and communicate systematic changes Ability to excel and adapt in a changing environment to work on multiple concurrent

projects and quickly assess multiple business processes Must have high degree of accuracy, and be detail-oriented Good time management skills, priority setting, deadline driven, results-oriented Strong organizational skills, ability to prioritize and coach others Strong verbal and written communication skills Extremely proactive, strong initiative, self-motivated High integrity, ethics and values Ability to project a professional presence Team-oriented work ethic, seeks to coach others and receive coaching where

appropriate Systems Competencies:

Strong knowledge of Microsoft operating systems: Excel, Word, PowerPoint, Access Ability to quickly adapt to understanding with multiple systems (JDE, HFM, Data

Warehouses, Concur, Paypath Infor, etc…) for multiple international entities Must possess strong Excel skills, ability to work with large, complex, spreadsheets are a

must. Comfort with innovative use of IT tools and new technology Experience with Business Intelligence tools is a plus

Education / Experience: Bachelor’s Degree required. Minimum of 10 years experience in compliance, audit, accounting, or IT Project Management experience required Must have experience in the medical device, healthcare, pharmaceutical or life science

related industries and a solid understanding of healthcare related spend. Demonstrated experience with ethics and compliance issues and knowledge of and

experience with healthcare regulations, including U.S. federal anti-kickback law, AdvaMed Code of Ethics and related regional codes of conduct on interactions with health care professionals, U.S. Federal Sunshine Act and other related laws, rules and regulations

Internal Audit and SOX background highly desired *************************************************************************

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Posted by Elizabeth Margoles, Talent Acquisition Please send your resume directly to Liz at lmargoles@accuray.com. Quality Systems Manager - Accuray needs a QS Manager with a medical devices background. Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company. The company develops, manufactures and sells personalized, leading-edge treatment solutions that revolve around the patient. Accuray's innovative technologies – the CyberKnife and TomoTherapy Systems – set the standard of care with the aim of helping patients live longer, better lives. ********************************************************** https://jobs.smartbrief.com/action/listing?listingid=71070891-76DA-4DBC-94A5-A1FAFAB6984D&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Payer Relations Director Sonitus Medical Inc. Job Description Job Summary: Work with commercial payers to develop Sonitus Medical/Pan partnerships, to enhance, improve service, and maintain contracts for SoundBite Hearing System. Coordinate with available resource sin the development of creative contracting strategies and services, healthcare industry developments, health plan risk contract models and competitor’s services to promote sales opportunities. Major Duties and Responsibilities: • Defines and implements strategies to increase revenue and develops plans utilizing available resources to effectively create access with payer customers. • Develops relationships with and sells to C-level health plan personnel so as to close for TheSoundBiteHearingSystem. • Negotiates contracts with payer customers for SoundBiteproduct and services to achieve revenuegrowth. • Services and maintains payer accounts and enhances business relationships through on going interaction with key payer customers. Provides proactive customer service, which includes facilitating resolution of customer issues and fulfillment of customer requests. • Interacts with all levels of personnel at targeted healthplans, including case managers, contracting, medical directors, Chief Marketing Officer, Chief Financial Officer and Vice President of Health Services. • Works closely with Corporate Reimbursement Director and Legal to develop, negotiate and execute contracts in a timely manner with terms that match Sonitus Medical strategic objectives. • Actively utilizes reporting and tracking tools to demonstrate payer penetration activities and provides to Management Team. • Demonstrates proficiency in the development and implementation of large group and individual presentations for targeted payer customers that contribute to grow business revenue. • Provides orcoordinates clinical support during the sales process to enhance payer awareness and increase utilization of SoundBite. • Demonstrates a highly interactive customer relations approach utilizing face-to-face contacts to build relationships and achieve desired results. Education / Qualification Requirements:

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• Required: Bachelor's degree,or equivalent, in healthcare,business or a relatedfield. • Preferred: Master'sdegree Skills / Experience: • Minimum five (5) years' successful sales experience selling to managed care organization at al llevels including the C-suite (CMO,CFO,CEO). • Must have a track record of demonstrated sales achievements and verifiable results calling on health plans. • Prosthetic/Orthotic and/or DME experience highly desirable. • Knowledge of, and experience with, payers in the market place is required. • Position is often required to independently develop strategies and prioritize sales/revenue objectives related to payer contracting. •Position requires frequent travel that will require overnight stays. • At all times, the incumbent must be aware of and adhere to all Federal and State laws and regulations in performing the duties of this position.· The incumbent must be aware of and adhere to the laws and regulations addressing relationships with patients, suppliers and referral sources. The incumbent must be familiar with, and adhere to, Sonitus Medical's "Code of Conduct" and its Compliance Policies and Procedures. •Proven track record of successful planning, prioritizing, and goal setting. •Commitment to task, influence & persuasion, decision making & problem solving, and flexibility. •Proven ability to "read the system" in order to plan, execute, and succeed. • Excellent interpersonal and communications skills and the ability to obtain and foster positive relationships with customers. ***************************************************************

Jobs That Crossed My Desk through May 26, 2013 ************************************************************* Posted by Harry Wachob Apply on company website Product Manager/Sr. Product Manager- Pacific Biosciences -Menlo Park The Product Manager/Sr. Product Manager will be responsible for key aspects of software and informatics product marketing for a fast growing DNA sequencing company. This includes assessing and prioritizing customer and market requirements, working closely with development to deliver market-leading products, and managing successful product launches. Job No: 1234 Position responsibilities and deliverables include to: • Deliver software and informatics product requirements with associated prioritization, metrics, and supporting analysis • Work very closely with development teams to ensure successful implementation of product requirements • Plan and lead successful product launches • Provide key input for detailed software and informatics product strategy and roadmap to meet company objectives • Contribute to business plans for software and informatics products that include opportunity assessment, positioning strategy, financial analysis, and required tactical plans to support successful adoption • Perform competitive and market analysis, including opportunity and barrier to entry assessment • Train field teams and support selling activities, including development of sales tools and collateral

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Requirements • Track record of success defining and launching excellent products • 4-6 years of relevant product management work experience in life science company or related field • Degree in molecular biology, computer science or associated scientific field required. • Excellent technical depth in informatics. Knowledge in DNA analysis informatics strongly preferred. • Clear ability to influence cross-functional teams without formal authority, and to work effectively with customers, development, and field teams • Outstanding teamwork and communication skills with high leadership potential • Must have a “can-do” attitude and be flexible in a fast-paced start-up environment. Experience in a start-up environment preferred. • Must be an intelligent individual with an excellent work ethic, exceptional judgment, and unquestionable integrity • Hands on, high energy, and highly responsive • Ability to travel up to 30% ******************************************************** Posted by Harry Wachob **Please email your resume to lisa.kwan@labsupport.com and use Sr PD Engineer as the subject line. Senior Process Development Engineer, Corneal Implant Lab Support, A Division Of On Assignment San Bruno Senior Process Development Engineer, Corneal Implant Job No: Corneal 1.The successful candidate will be responsible for process scale-up, process equipment identification, the design of process fixtures and tooling, and conducting experiments to establish process parameters and process capability for a manufacturing process for an implantable biodegradable medical device. The candidate is expected to play a major role in designing and developing a full-scale commercial production process. 2.Participate in process equipment IOQ, process performance evaluation, and write validation reports 3.Responsible for tech transfer to commercial production site(s) 4.Involved in clinical production activities such as preparing SOPs, batch records, and hands-on GMP production 5.Perform product testing, product performance verification and validation activities. Take responsibility for designing and executing experiments. Author protocol and test reports. 6.Assist in Design Control activities involved with medical implant. Requirements -The ideal candidate will be a biomechanical, biomedical, or medical engineer with 10 plus years of experiences in medical device industry. -Strong process engineering backgrounds in contact lens or intraocular lens (IOL) industry are highly desirable. -Strong background in mechanical engineering, CAD, and SolidWorks. -Backgrounds in electric engineering, automation, robotics, and protein biochemistry a plus. -Familiar with cGMP and working in a regulatory environment. -The ideal candidate shall have a minimum education level of BS degree. Candidates with a BS

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degree yet strong industrial experiences will still be considered. -MS, PhD preferred. ONLY LOCAL CANDIDATES WILL BE CONSIDERED. ******************************************************* Posted by Harry Wachob Apply on company website

Regulatory Affairs Specialist AccessClosure, Inc. - Mt View

Job No: 13-9045 Provide administrative and technical support to Regulatory Affairs management in order to remain in compliance with all FDA and other U.S. and international regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis: • Prepare portions of IDE, PMA and Design Dossier original submissions and subsequent revisions/supplements and amendments • May participate in project team meetings as a Regulatory representative • Coordinate regulatory submissions • Assist with preparation of presentations to FDA reviewers and/or inspectors as needed • Maintain a library of publications and articles • Maintain a well-organized and efficient filing system of all clinical and In-vivo trial records • Ensure compliance with FDA and European regulations and guidelines as well as relevant company SOP’s and protocols • Provide assistance with international product registrations and licensing requirements • Maintain information in various compliance databases and produce reports as needed Requirements EDUCATION/EXPERIENCE: • Bachelors’ degree in related discipline and 2+ years related experience in regulated health-care related industries (hospitals, labs, pharma, IVD or devices), experience in the medical device industry. • Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings a plus • An advanced degree is desirable. Interventional cardiology experience would be a plus SKILLS and ABILITIES: • Excellent written and oral communication skills; technical writing capabilities are a must • Ability to multi-task, and work independently with minimal supervision • A hands-on, decisive, action-oriented style must be evident. • Organized, extensive attention to detail and accuracy • Ability to work with cross-functional teams to achieve common goals

***************************************************** Posted by Lauri.Loris@InVentivhealth.com Lauri Loris is Senior Recruiter at InVentivhealth Registries Epidemiologist/ Project Manager InVentivHealth Clinical- South San Francisco, CA (San Francisco Bay Area) Job Description

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- Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these - Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals - Asks questions when in doubt - Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct - Is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company - Preferably has expertise in neuroscience and mental health registries and observational studies 2. Team Support & Leadership - Work with the team lead/lead expert and primary contact from gMED Patient Registries regarding the Patient Registries strategy, plans and programs for the assigned molecules/products. Includes ongoing work as well as any special projects - Participate as needed in broader Medical Team relevant to assigned molecules/products as needed - Collaborative on cross-functional protocol, analysis, reporting and study management teams: * Leads and manages ongoing team meetings, minutes, communications and interactions * Organizes the work of the assigned team(s) to include strategy development, implementation and oversight of execution * Ensures assigned team's input is provided in a robust, targeted and timely manner to other associated Company or global teams * Provides regular status updates and reporting on team progress and key activities to internal customers, partners and stakeholders * Ensures strategies, plans, goals, objectives and targets will be met or exceeded - Participates in and/or leads special departmental projects - Identifies and recommends process and other improvements; whether pertinent to his/her specific department and/or beyond - Participates in various staff meetings, including regular one-on-one meetings with his/her manager 3. Patient Registries Development & Planning - Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact each assigned molecule/product, the overall franchise, disease and/or therapeutic area. Includes attendance at major scientific and/or medical conferences, participation in competitive intelligence activities and projects, and review of published scientific and clinical literature - Maintains the highest standards and levels of scientific, clinical and technical expertise in specific therapeutic area(s) of assignment - Plays a role in coordinating and providing Patient Registries input into the assigned disease area's medical and commercial strategies - Responsible for developing the patient registries, observational and related studies strategies, plans and programs for the assigned molecules/products: * Assist in the development and implementation of tactical plans for each patient registry, observational and related study, including the scientific rationale and research plan, research questions to be answered and hypotheses to be tested, key opportunities for collaboration and publication, medical communications, KOL development and cultivation, medical education, development and implementation of advisory boards, and key timelines * Assist to ensure alignment of Patient Registries strategies, plans, programs and objectives with medical strategies and plans * Assist with the designs of observational and related studies and patient registries. Partners with key experts to keep abreast of the latest trends and advancements in methodologies

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* Works with various internal and external partners, including CRO vendors (Clinical Research Organizations) and other consultants, to finalize tactical implementation plans for each patient registry and study * Assist with developing and tracking budget and other resource plans to align with and support the successful execution of Patient Registries strategies, plans and objectives. * Assists in the development and delivery of key presentations, both internally and externally, to convey the medical perspective and provide updates on activities for the assigned molecules/products 4. Operations - Works closely with various internal and external partners in the execution of each study and registry: - Ensures alignment of study and patient registry design with relevant pre-clinical and clinical data and outcomes as well as commercial and medical Desired Skills & Experience Education: - Relevant Bachelor's degree in CS, MIS, Life Sciences, Business; or equivalent experience InVentivHealth Clinical Additional Information Posted:May 23, 2013 Type:Contract Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals, Biotechnology Job ID:5819464 ******************************************************** See more at: http://www.kleinhersh.com/position.aspx?job=140#sthash.VmqWI312.dpuf Contact: Tom Hayes Phone: 215.830.9211 ext 129 Position Overview A large cap biotech client is expanding operations into the biosimilars area. As a result, we are looking for GCP compliance experts. We are offering: competitive salaries, career growth & development, employee pension, 401k matching and other excellent benefits to the in process Clinical Compliance professional who can meet the challenges faced in an evolving regulatory landscape. Job Responsibilities Quality and Process Management The employee works collaboratively across global pharmaceutical development applying knowledge of GCP’s / good clinical practices, regulatory guidelines and applicable regulations to standard procedures and supporting documentation. The incumbent is responsible to monitor and document adherence to company Policies, SOPs, and all applicable regulations and guidelines. In addition, is responsible for the global pharmaceutical development Quality Management System including management, development, maintenance, and revision of controlled documents and processes ensuring alignment and consistency. The incumbent is responsible for management and oversight for Clinical / GCP global pharmaceutical development process maps. The incumbent is responsible for management and oversight of the CAPA process within global development and responsible for CAPA tracking including analysis and reporting of quality metrics. In addition, the incumbent is responsible for the development and implementation of tools which support clinical quality management within Global Development. The incumbent is responsible for close collaboration with Global Regulatory Compliance to identify trends from Clinical Quality Assurance audits and to ensure plans are in place for remediation. In addition,

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the incumbent is responsible for the development and oversight of Inspection Readiness program initiatives and supports continuous improvement initiatives. This position will NOT be responsible for any auditing, but will work closely with clinical development staff to provide FDA / regulatory guidance to clinical operations staff on GCP’s and associated regulations governing clinical trials and clinical drug development. Job Requirements The ideal candidate has both operational and compliance/quality background but must have experience that provides evidence that they have the knowledge and breadth of experience to provide in-process compliance support to teams (e.g. identification of issues, ability to facilitate root cause analysis and creation of meaningful corrective/preventative actions, working within the business to promote in-process clinical quality control). Location(s) Irvine, CA / Bridgewater, NJ

- If interested, please send a MS Word version of your resume to thayes@kleinhersh.com ******************************************************** Posted by Started by Daniel Roberts, Consumer Safety Officer (Investigator) at FDA FDA San Francisco District Investigator position available. See link below for additional information. https://www.usajobs.gov/GetJob/ViewDetails/343693500 ************************************************************ http://www.linkedin.com/jobs?viewJob=&jobId=5832827&trk=eml-anet_dig-b_premjb-ttl-cn&ut=0N6_uJjqQuilM1 Clinical Program Manager Atchison Staffing- San Francisco Bay Area Job Description Join a premier portfolio management and program delivery team for strategic, clinically innovative programs within this growing healthcare organization. The Clinical Program Manager is responsible for overseeing and driving internal and external strategic programs such as Accountable Care Organizations (ACO), Patient Centered Medical Home (PCMH) and other strategic programs or projects as assigned. This individual will be managing very visible, cross-functional, cross-organizational and highly complex projects. The Clinical Program Manager will works across all functional areas of the organization (clinical, analysis, marketing, etc.) as well as with key business partners to define and manage the execution of Programs and Projects. Desired Skills & Experience

Master's degree in healthcare related field or equivalent experience. Minimum 10 years of industry experience leading large complex projects with internal

and external stakeholders 8 years of experience managing and developing highly skilled project teams 5 years of experience managing external client relationships (e.g., sponsors,

stakeholders, business partner, vendors, etc.) 3 years of experience in a health care setting (inpatient, outpatient, care management

or health plan) Experience working with cross functional teams while handling multiple projects

simultaneously Expert level group facilitation and presentation skills and ability to collaborate across

diverse teams Experience in consultative role Project Management Institute PMP Certification

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Direct experience with change management methodology, communication strategy and training methodology

Process improvement using formal methodology (e.g., Lean, Six Sigma, etc.) Company Description Our primary recruiting focus is within the medical and healthcare informatics, analytics and related IT fields. Specialties • Business Development– Sales “Hunters & Farmers” • Professional Services – Account Management, Delivery, Implementation, Training • Database and Data Warehouse Architecture, Development & Analytics • Information Technology Infrastructure & Management • Management – VP, Director, Manager • Product Management & Marketing • Project Management & Business Analysts • Revenue Cycle Consulting • Subject matter expertise (Cerner, EPIC, GE/IDX, McKesson, Meditech, and Trizetto Facets or QNXT) Additional Information Posted:May 24, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management Industries:Hospital & Health Care Compensation:$115-$135k base salary + bonus & benefit Employer Job ID:20213398 Job ID:5832827 ************************************************************ Posted by Jim Doyle, Senior Recruiter at Theorem Clinical Research http://www.linkedin.com/jobs?viewJob=&jobId=5833113&trk=eml-anet_dig-b_premjb-ttl-cn&ut=35nqLMG6EfilM1 Project Data Manager (Home-based/Remote) Theorem Clinical Research - Remote (California) (San Francisco Bay Area) Job Description JOB SUMMARY Supervise and mentor assigned Clinical Data Management staff. Manage project budgets, timelines, resource planning, and overall quality of data management services of assigned projects/sponsors. JOB RESPONSIBILITIES - Evaluate and manage project budget against project milestones to ensure project profitability. Take corrective measures where necessary to keep project in line with budget and profit expectations. Track scope changes and obtain sponsor approval for change orders. Review, approve and follow-up on sponsor invoices. - Supervisory position managing activities of Clinical Data Management staff assigned to specific sponsors. Perform Annual Employee Performance Evaluations. - Establish appropriate project tracking using computer assisted programs and ensure timely entry of project information. Ongoing QC review of posted study documentation in study portal and in PMF for completion and audit readiness. - Manage timelines for assigned protocol(s) and ensure that all applicable Clinical Data Management staff are aware and on target for all sponsor company deliverables. Manage

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sponsor expectations with regards to scope of work and deliverables. Ensure efficient cross functional handoffs. - Escalate any potential or actual issues to supervisor, project team, and/or sponsor company in a timely manner with suggested resolution, and follow issues through to resolution. - Ensure that Clinical Data Management staff documents initial and ongoing training as required by both Theorem and the sponsor company. - Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation. - Present CDM function at conferences, external non-study meetings, etc. Attend Bid Defense Meetings and provide input into proposals as requested. Desired Skills & Experience KEY SKILLS & BEHAVIORS - Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills. - Keeps internal and external sponsors informed of project and/or technical issues by pro-actively communicating across teams/functions. - Manages and directly supervises assigned clinical data management team. - Communicates effectively through both written and verbal methods. - Anticipates changing priorities and demands and addresses them proactively. - Manages time effectively in order to produce quality deliverables in expected timeframe. - Exemplifies, delivers and expects professionalism using strong interpersonal and organizational skills. TRAINING AND EXPERIENCE 1. Medical/Nursing, Life Science/Mathematical Degree or relevant experience. 2. 6+ yrs. experience, of which 2 yrs. must have been as Data Manager (or proven managerial experience); Experience leading multiple studies simultaneously. Company Description Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's leading pharmaceutical, biotech and medical device companies. A leader in medical device and drug-device combination trials in addition to a notable capability in pharmaceuticals and biologics, Theorem has deep expertise in a broad range of therapeutic areas and in all phases of development. Some of the industry's top scientists and most advanced clinical analytics capabilities help ensure smooth-running, successful trials. For a full-service, right-size global research partner, don't think twice. THINK THEOREM. Theorem Clinical ResearchAdditional Information Posted:May 24, 2013 Type:Full-time Experience:Mid-Senior level Functions:Research Industries:Pharmaceuticals Job ID:5833113 ***************************************************************** https://jobs.smartbrief.com/action/listing?listingid=71070891-76DA-4DBC-94A5-A1FAFAB6984D&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Payer Relations Director Sonitus Medical Inc. Job Description Job Summary:

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Work with commercial payers to develop Sonitus Medical/Pan partnerships, to enhance, improve service, and maintain contracts for SoundBite Hearing System. Coordinate with available resource sin the development of creative contracting strategies and services, healthcare industry developments, health plan risk contract models and competitor’s services to promote sales opportunities. Major Duties and Responsibilities: • Defines and implements strategies to increase revenue and develops plans utilizing available resources to effectively create access with payer customers. • Develops relationships with and sells to C-level health plan personnel so as to close for TheSoundBiteHearingSystem. • Negotiates contracts with payer customers for SoundBiteproduct and services to achieve revenuegrowth. • Services and maintains payer accounts and enhances business relationships through on going interaction with key payer customers. Provides proactive customer service, which includes facilitating resolution of customer issues and fulfillment of customer requests. • Interacts with all levels of personnel at targeted healthplans, including case managers, contracting, medical directors, Chief Marketing Officer, Chief Financial Officer and Vice President of Health Services. • Works closely with Corporate Reimbursement Director and Legal to develop, negotiate and execute contracts in a timely manner with terms that match Sonitus Medical strategic objectives. • Actively utilizes reporting and tracking tools to demonstrate payer penetration activities and provides to Management Team. • Demonstrates proficiency in the development and implementation of large group and individual presentations for targeted payer customers that contribute to grow business revenue. • Provides orcoordinates clinical support during the sales process to enhance payer awareness and increase utilization of SoundBite. • Demonstrates a highly interactive customer relations approach utilizing face-to-face contacts to build relationships and achieve desired results. Education / Qualification Requirements: • Required: Bachelor's degree,or equivalent, in healthcare,business or a relatedfield. • Preferred: Master'sdegree Skills / Experience: • Minimum five (5) years' successful sales experience selling to managed care organization at al llevels including the C-suite (CMO,CFO,CEO). • Must have a track record of demonstrated sales achievements and verifiable results calling on health plans. • Prosthetic/Orthotic and/or DME experience highly desirable. • Knowledge of, and experience with, payers in the market place is required. • Position is often required to independently develop strategies and prioritize sales/revenue objectives related to payer contracting. •Position requires frequent travel that will require overnight stays. • At all times, the incumbent must be aware of and adhere to all Federal and State laws and regulations in performing the duties of this position.· The incumbent must be aware of and adhere to the laws and regulations addressing relationships with patients, suppliers and referral sources. The incumbent must be familiar with, and adhere to, Sonitus Medical's "Code of Conduct" and its Compliance Policies and Procedures. •Proven track record of successful planning, prioritizing, and goal setting. •Commitment to task, influence & persuasion, decision making & problem solving, and flexibility. •Proven ability to "read the system" in order to plan, execute, and succeed.

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• Excellent interpersonal and communications skills and the ability to obtain and foster positive relationships with customers. ******************************************************** Organic Chemist MoTek Technologies - Menlo Park, CA (San Francisco Bay Area) Job Description We are looking for an Organic Chemist/Biochemist with an established track record of accomplishments in either academic or company settings. Responsibilities and Requirements:

Ph.D/M.Sc/B.Sc level organic chemist with experience in ligand conjugation chemistry both in solution and on solid surfaces, experience with chemical surface characterization and chemical derivatization of surfaces and soluble molecules.

Thorough understanding of biochemistry and hands-on experience working with biomolecules.

Ability to independently design and execute experiments, do in-depth data analysis and present results and conclusions for internal review.

A plus if experience with product development, process transfer, manufacturing scale-up, quality control procedures and controlled documentation processes.

Innovative, driven, results-oriented and methodical, with record of achievement commensurate with previous experience.

Collaborate well within a multidisciplinary organization and used to work within tight schedules.

Please submit your updated resume to Kevin@MoTekTech.com Desired Skills & Experience For more openings please visit our Jobs page at http://motektech.com/listings.php Company Description http://motektech.com/ Additional Information Posted:

May 22, 2013 Type:

Full-time Experience:

Mid-Senior level Functions:

Engineering Industries:

Biotechnology Compensation:

$120,000- $150,000 DOE Employer Job ID:

5487841 Job ID:

5809654 __________________________________________________ http://www.linkedin.com/jobs?viewJob=&jobId=5809263&trk=jobs_seeking_view_job&goback=%2Evjs_5820829_*2_*2_*2_false_*2_*2 Molecular Biologist MoTek Technologies- Menlo Park, CA (San Francisco Bay Area) Job Description

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We’re looking for talented and organized team players to join our fast-paced startup. Specifically, we are looking for a Ph.D level molecular biologist with extensive publication list and proven product development record in either academic or company settings. Responsibilities and Requirements:

Ph.D level molecular biologist with extensive experience in nucleic acid methods and product development.

Thorough knowledge of nucleic acid biochemistry, broad experience working with molecular biology reagents and a minimum of 5 years of hands-on experience working with and developing nucleic acid based assays.

In-depth knowledge and experience optimizing PCR and isothermal amplification techniques, solid phase nucleic acid amplification methods, clonal amplification, ligation assays, DNA purification and size selection approaches.

Experience with miniaturized and automated enzymatic assays, and with highly parallelized sample processing methods.

Proven ability to independently design studies, define goals, produce experimental plans, execute experiments, do in-depth data analysis and present results and conclusions for internal and external review.

A plus would be if you have experience with product development, process transfer, manufacturing scale-up, quality control procedures and controlled documentation processes.

Innovative, driven, results-oriented and methodical, with record of achievement commensurate with previous experience.

Leadership skills, ability to collaborate within a multidisciplinary organization and used to work within tight schedules.

Please submit your updated resume to Kevin@MoTekTech.com Desired Skills & Experience For more openings please visit our Jobs page at http://motektech.com/listings.php Company Description http://motektech.com/ Additional Information Posted:May 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering Industries:Biotechnology Compensation:$140,000- $165,000 DOE Employer Job ID:401389 Job ID:5809263 ****************************************************** http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=2951 Health and Safety Manager (Sacramento) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Health and Safety Manager to work for a leading Bay Area biotechnology company. Health and Safety Manager BioPhase Solutions is recruiting for a Health and Safety Manager with our client located in Sacramento, CA. This position is full-time, direct-hire and relocation is possible. ******************************************************* Apply on company website To apply: Visit the Careers page at www.BMRN.com

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EH&S Openings BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY BioMarin currently has several openings in it’s EH&S department. These positions will support the overall BioMarin Environmental Health and Safety operations in the following areas: Ergonomics, Analysis, and Environmental Health. Duties may include: assisting with Cal OSHA compliance requirements and industrial hygiene sampling throughout GMP manufacturing facilities, research laboratories and office environments. Conducting ergonomic assessments in office, manufacturing and laboratory environments and providing training to personnel. Participating as a member of the Emergency Response Team and responding to EH&S emergencies. Providing support for health and safety programs managed by others within the department. To apply: Visit the Careers page at www.BMRN.com Desired Skills & Experience EDUCATION Requires a Bachelor’s degree from an accredited college or university with major course work in occupational health, industrial hygiene, chemistry, industrial engineering, safety engineering, or a closely related field. EXPERIENCE

5+ years experience working in an EH&S capacity. Requires knowledge of EH&S responsibilities, OSHA (federal and state) regulations,

procedures and business practices. Must have understanding of industrial hygiene sampling, methods and hierarchy of

controls required. Strong problem solving skills

To apply: Visit the Careers page at www.BMRN.com Company Description At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them. Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us. EEO/M/F/D/V Additional Information Posted:May 23, 2013 Type:Full-time Experience:Mid-Senior level Functions:Quality Assurance Industries:Biotechnology Job ID:5820829 ******************************************************** IT Senior Project Manager – Full Time Position (San Francisco Bay Area) To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Clara@JGBBioPharma.com. No Work Visa

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sponsorship is available for this job. DESCRIPTION: • Accountable for coordinating, managing and reporting status on various IT projects; will be dotted-line reporting to the VP of IT. • Partner with IT management, business stakeholders and various external project managers to manage the development and execution of IT Projects and to optimize team effectiveness in achieving project objectives in alignment with budget and timeline. • Establish and maintain functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes; • Ensures alignment with various project teams including projects led by consultants or integrators • Prepares project plans (activities, schedules), provides regular project status reports and maintains a dashboard view of all IT projects with key milestones and dependencies • Tracks project progress with respect to schedule, budget, quality and demonstrated project benefits. • Recognizes project issues/risks early on, defines mitigation strategies and escalates early • Resolves scope, schedule, resource and financial conflicts. • Communicates with all stakeholders, management and project team as defined in the project communication plan. • Facilitate project team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders. • Identifies, recommends, and manages the implementation of process and other improvements; whether pertinent to departmental and/or corporate. EXPERIENCE AND QUALIFICATIONS: • Experience within the pharmaceutical/biotech industry and understanding of FDA/GxP validation requirement • Strong proficiency with project management practices, tools, and methodology. • Financial acumen; capable of planning and oversight of project budgets and product valuations and an understanding of portfolio management concepts. • Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills. • Excellent analytical skills, with an ability to communicate complex issues in a simple way. • Demonstrate ability to translate strategy into action; • Strong influence, negotiation, and presentation skills. • Proven track record of good decision making and exercising sound judgment. • Results and detail-oriented; self-motivated. • Proven experience using Project Management software to manage complex project timelines and resources. • Experience of managing senior stakeholders gained either in pharmaceuticals or in outsourcing/ consulting companies. • Fluent English skills (written and spoken). • Relevant Bachelor's degree in Computer Sciences, MIS, Life Sciences, Business; or equivalent experience. • 5 - 10 years in Informatics project management; having managed medium/large size global/local projects in multi-cultural environments ********************************************************* Inside Sales Executive Sanguine Biosciences, Inc.- Greater Los Angeles Area Job Description

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Half your job is to close leads and the other half is to make your own. You will work as part of the marketing and sales team promoting patient samples, and patient sample collection services to researchers at pharmaceutical companies, biotechnology companies, and academic institutions. Every day you will be tasked with our growth hackers to convert traffic into leads, nurturing those leads, and sourcing those leads to the outside sales team, for them to close. You will manage your own time and you will be judged on hitting your quota. Only self-starters need apply. Desired Skills & Experience SKILLS A born communicator Technically proficient in concepts and principals (i.e. you don't need a PhD, but an understanding of basic biological sciences or clinical development is a plus) You love hunting for new business through a combination of lead follow up and prospecting Ability to understand and analyze customer requirements and to demonstrate product solutions effectively Actively maintain a sales pipeline and document activity utilizing SalesForce Achieve or exceed assigned monthly/annual sales quotas Organized and able to prioritize and manage your schedule Passionate, with the ability to infect others with your passion Understanding and capabilities of working with the marketing team REQUIREMENTS 2-4 years of experience selling consumables or services to researchers at pharma Ability to work in a very fast paced and constantly changing environment A NEED to take ownership of whatever task is in front of you You are never bored because you will take initiative to do the next thing You must be proactive and amicable Company Description Sanguine BioScience empowers patients in biomedical research by providing their samples to researchers while delivering transparency to patients on how the samples were used throughout the process. The company is building a library of patient data that will be used by researchers for R&D, and by physicians for better clinical decision-making. Researchers purchase patient samples from Sanguine because the samples are of high quality, and are joined with high-quality data including patient self-reported information and de-identified medical data. The company already has clients at Fortune 500 companies and world-renowned academic institutions. But, we are only scratching the surface. We are currently ramping up our marketing efforts to generate leads, and we're looking for the best sales people to convert them into customers. Additional Information Posted:May 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology Job ID:5580203 *********************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5780645&trk=eml-anet_dig-b_premjb-ttl-cn&ut=332ZxPiAyOe5M1 Technical Sales Executive Lifeline Cell Technology- Greater San Diego Area

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Job Description ***LOCAL CANDIDATES ONLY*** The TSE is a relationship based sales/marketing position. The majority of the work is done over the phone and on the internet. Travel in territory is required for client visits to expand sales. Some travel for trade shows or company presentations is required both in and outside of territory. The TSE will maintain and manage a funnel of potential customers while continuously seeking out new prospects. Responsibilities include:

Developing Sales Opportunities by researching and identifying potential accounts; soliciting new accounts via telephone and e-mail; building rapport; providing technical information and explanations; preparing quotations.

Developing technical proficiency in all products offered by company thorough hands on training provided by Lifeline and independent literature review.

Maintaining and further developing accounts in respective territory. Attending trade shows and events. Maintaining and updating of the company database. Sending promotional and informational e-mails to current and potential customers using

Swiftpage to institutions within territory. Handling field technical issues and following up on client complaints. Processing custom product requests. Working in a team environment to obtain information to resolve customer issues. Recording all complaints through non-conformance reporting.

Essential job functions: Meet or exceed sales targets for all products and assigned business objectives. Develop tactical plans to maximize revenues. Implement corporate strategy in defined key accounts. Negotiate contract and execute

pricing strategy to maintain existing business and develop new business. Through consultative selling, enhance customer satisfaction and increase our

advantages while building trust and relationships with customers. Develop strong relationships with key customers. Develop technical proficiency in all products offered by company through hands on

training and independent literature review. Handle field technical issues and follow up on client complaints. Meet or exceed call minimums. Develop and execute an effective business plan for the assigned territory. Perform daily

pre-call planning for increased sales effectiveness. Recognize market trends and gain competitive intelligence within territory. Drive and

initiate development of new business opportunities in defined area. Involve and support team members to achieve mutual company goals and objectives. Daily use of ACT database for input and output of customer information to increase

sales effectiveness. Desired Skills & Experience Minimum Education (or substitute experience) required: BA or BS. Minimum Experience required:

5+ years sales experience. Some Telesales experience preferred. Biotech or technical sales experience is preferred but not necessary.

Skills Required: Sales skills – strong tele-sales Strong product presentation skills required for phone and e-mail communications.

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Tradeshow experience – ability to create product interest, answer questions, present products to a wide cross-section of scientific community.

Computer skills - Customer Database Maintenance and Management; Spreadsheets (analytic skills important)

Interpersonal relations - must be skilled in dealing with people both over the phone and in person.

Company Description Lifeline Cell Technology® (Lifeline) specializes in the development and manufacture of purified primary human cells and optimized reagents for cell culture. Lifeline' s scientists have been working in this important field of cell culture for over 20 years and developed many of the human cell systems and the quality standards that are used today in academic, government and pharmaceutical laboratories to study human disease. Our team of scientists and quality control technicians continue to make new and improved human cell systems to meet the needs of a more demanding cell culture marketplace for primary human cells and are making breakthroughs in the development of human stem cell products. Our technical account representatives take pride in providing superior customer and technical service and will work diligently to assist you with your cell culture requirements. Lifeline is a wholly owned subsidiary of International Stem Cell Corporation, (ISC) (ISCO.OB) Additional Information Posted:May 20, 2013 Type:Full-time Experience:Associate Functions:Sales Industries:Biotechnology Job ID:5780645 ******************************************************* Apply on company website Posted by Janelle Kernaghan 2nd Human Resources Representative at Halozyme Therapeutics, Inc. ASSOC DIR/DIRECTOR, NEW MOLECULAR ENTITIES Halozyme Therapeutics, Inc.- Greater San Diego Area Job Description POSITION SUMMARY: This individual is expected to lead NME-specific molecular biology, assay development and purification activities in the NME vertical. This position is responsible for the generation and bench-scale synthesis of New Molecular Entities (NME) at Halozyme, and for the generation of associated intellectual property. Integrating with functional project teams, this position will be responsible for leading the vertical that generates pilot recombinant and synthetic molecules suitable for in vitro and in vivo pharmacology, PK and early toxicology testing. The Associate Director of NME is also responsible for transferring core knowledge and assays to Halozyme drug development groups when full scale development decisions are made on a molecule. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These include, but are not limited to:

Hire, develop, manage, and appraise staff in the NME group, ensuring optimal performance with individual project teams and other verticals.

Utilize creative expression and/or synthesis techniques for rapid proof of concept studies and intellectual property.

Report writing as needed to support regulatory and intellectual property needs Develop small scale purification strategies using diverse techniques.

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o Develop vectorlogy and cell lines for high-level expression for use in future GMP manufacturing.

o Established record of innovation in the field of synthetic monoclonal antibody technology

o Establish standards of performance that emphasize innovative, high quality R&D efforts that are recognized outside the department and outside the company

o Direct and consult in the development of quantitative assays for use in the research projects

o Direct and/or participate as member or leader of project teams o Preparation of material for written and verbal presentation to peers and

management, including internal reports. o Coordinate external research with collaborators and contract research

organizations o Represent the company's advances to scientific peers in publications and

presentations. ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:

Conduct laboratory operations while observing Environmental, Health and Safety requirements.

Participate in annual budget preparations and updates Assure Halozyme’s access to state of the art technology related to drug discovery Other duties as assigned.

Desired Skills & Experience EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

Ph.D. with 7 years experience in a biopharmaceutical company. Experience with molecular modeling toward innovative protein therapeutics Comprehensive knowledge of molecular and cell biology and methods of recombinant

protein production and purification. Excellent scientific analysis and interpretation skills and problem solving skills. Excellent organizational skills. People management experience and ability to work well in a multidisciplinary matrix

based environment. Ability to interact effectively within a wide spectrum of disciplines. Team player with positive and professional leadership qualities.

TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: INTERNAL AND EXTERNAL RELATIONSHIPS:

The Associate Director/Director will report to the Chief Scientific Officer. This position interfaces extensively and routinely with all levels of project teams,

product development, manufacturing, regulatory, quality and finance department personnel.

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

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Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

General biology and chemical laboratory environment. General office environment. Laboratory environment health and safety requirements apply to this position. Domestic

and international travel as required. TRAVEL: Travel may be required up to 5% of your time Company Description Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. Our research targets the extracellular matrix, an area outside the cell that provides structural support in tissues and orchestrates many important biological activities, including cell migration, signaling and survival. Over many years, we have developed unique scientific expertise that allows us to pursue this target-rich environment for the development of future therapies. The company's research focuses primarily on human enzymes that alter the extracellular matrix. Our lead enzyme, the recombinant human hyaluronidase (rHuPH20), temporarily degrades hyaluronan, a matrix component in the skin, and facilitates the dispersion and absorption of drugs and fluids. We are also developing novel enzymes that may target other matrix structures for therapeutic benefit. Our ENHANZE™ Technology is the platform for the delivery of proprietary small and large molecules. We apply our research to develop products in partnership with other companies as well as for our own proprietary pipeline in therapeutic areas with significant unmet medical need, such as diabetes, oncology and dermatology. We market Hylenex® recombinant (hyaluronidase human injection) and have partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. Halozyme Therapeutics, Inc.Additional Information Posted:May 13, 2013 Type:Full-time Experience:Director Functions:Research Industries:Biotechnology, Pharmaceuticals Compensation:Salary, Bonus, Stock Options Job ID:5707166 _____________________________________________________________ DIRECTOR, REGULATORY AFFAIRS Halozyme Therapeutics, Inc.- San Diego (Greater San Diego Area) Job Description POSITION SUMMARY: The Director of Regulatory Affairs (RA) is responsible for the regulatory affairs function as assigned. The assignments currently include regulatory management of commercial products including the leadership of the committee for promotional and advertising committee review of marketing materials and products and Halozyme or Partnered products in development. This is a cross functional role that for commercial products which requires a sound functional knowledge of pharmacology. toxicology, and clinical. As the regulatory representative for the promotional and advertising committee the Director of RA is the internal company expert regarding the United States federal and state regulations and requirements for marketing/promotion and labeling requirements for Halozyme commercial products. For assigned developmental programs and products the Director of RA will work closely with Research and Development, Product Development, Preclinical Safety and Clinical Development to ensure an effective linkage of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. Regulatory filings can include the following: INDs, lMPDs, NDAs, MAAs. 510(k)s, PMAs, CE Conformity Technical Files, Annual Reports, Amendments, and Supplements. The Director of Regulatory Affairs will provide worldwide

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regulatory leadership direction, and participation to the organization and to specific projects. The role requires strong independent organizational leadership and values while directing the regulatory future of Halozyme Therapeutics programs. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These include, but are not limited to:

A primary function of the position will be to provide the commercial product team with regulatory strategies and tactics to ensure effective implementation advances in the product characteristics, clinical applications and supply considerations.

A primary function of the position will be to provide the assigned development programs and product teams with the regulatory strategies and tactics to ensure linkage between the development program and requirements for licensure.

A primary function of the position will be to serve as the regulatory representative on the Halozyme Promotional and Advertising Review Committee (PARC). This leadership role with ensure that Halozyme’s advertising and promotional activities will be within the

To utilize critical review and creative problem solving skills to apply regulatory and therapeutic area clinical knowledge to initiatives that meet marketing objectives while minimizing compliance risks.

To evaluates technical and scientific information, references, dossiers, provided in support of product claims and attributes

To establishes contacts and meetings to gain commitments and to facilitate review of applications and dossiers with government and regulatory agencies.

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES: Other duties as assigned.

Desired Skills & Experience EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

BS/BA or higher in a scientific discipline and a minimum of 8 years strategic regulatory leadership and planning experience in commercial product labeling and commercial promotion and advertising regulations.

Experience interacting with FDA (e.g., OPDP, APLB) Strong oral and excellent written communication skills. Strong interpersonal skills and the ability to deal effectively with a variety of business

areas, at all levels within the organization, including clinical, marketing, sales, research and development staff.

Energetic person with ability to prioritize and focus on multiple projects at the same time.

Creative approach to problem solving; ability to deal with ambiguity and declare a clear path forward.

Must have a demonstrated track record of being results driven. TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Software Knowledge: Windows, MS Office (Outlook, Word, Excel), Adobe, eCTD, etc. INTERNAL AND EXTERNAL RELATIONSHIPS:

Regulatory, Quality Assurance, Preclinical, Product Development , Clinical Development, Marketing and Sales, Legal Affairs

External consultants Halozyme Alliance Partners and vendors

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those

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that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply. TRAVEL: Travel may be required up to 20% of your time. Company Description Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme’s Enhanze technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche’s biological therapeutics, including Herceptin®, for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid®. The product candidates in Halozyme’s research pipeline target multiple areas of significant unmet medical need. Halozyme Therapeutics, Inc.Additional Information Posted:May 13, 2013 Type:Full-time Experience:Director Functions:Other Industries:Biotechnology, Pharmaceuticals Compensation:Salary, Bonus, Stock options Employer Job ID:2012-2921 Job ID:5706690 ******************************************************** Derm Rep - San Francisco Now hiring: Derm Rep - San Francisco http://www.ziprecruiter.com/job/Derm-Rep-San-Francisco/714212d2/?source=social-linkedin-group-jobs ****************************************************** Apply on company website Sr. Technical Consultant (Network) Veeva Systems- San Francisco, CA (San Francisco Bay Area) Job Description Join one of the fastest growing companies in high tech. Veeva Systems is a pre-IPO provider of cloud-based solutions to the life sciences industry. Profitable and cash-flow positive, Veeva is experiencing rapid growth as the market expands for industry-specific, cloud-based software solutions. Veeva has systematically grown its customer base each year since its founding in 2007 and the accolades are growing. Veeva was ranked one of the “25 Enterprise Start-ups To Bet Your Career On,” and was recently profiled by Bloomberg and in Tech Crunch (“Vertical is the New Horizontal”). Become part of the high performing team that is leading the next wave in cloud-based applications--the move to industry-specific solutions.

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Job Summary: Veeva Network is the industry’s first complete, cloud-based customer master solution that combines healthcare professional, healthcare organization, affiliations and reference data, software and stewardship services in a single solution that’s seamlessly integrated with Veeva CRM. Veeva Network harnesses the ‘network effect’ of life sciences companies electing to work together to contribute updates to master data repository. The result is accurate, complete and always up-to-date customer data within Veeva CRM. As a Senior Technical Consultant, you will be a member of the Veeva Systems Professional Services group implementing the Veeva Network solution for companies in the life sciences industry. Lead the assessment, planning, and implementation phases of Veeva Network projects. Collaborate with Customers, Vendors, and Veeva CRM resources to deliver high quality solutions and drive Customer success. Responsibilities:

Implementation lead for Veeva Network services delivery projects. Responsible for assessment, planning, and implementation of new Customer master applications, with additional focus on changes to business processes and integrated systems.

Execute data quality assessments, articulate factors involved in systemic data quality, and manage end-state expectations

Take complex data management concepts and articulate them to audiences of varying perception levels

Work with product management team to share feedback and inform the product enhancement process

Provide direction to junior resources, and develop best practices and accelerators Requirements:

Excellent verbal and written communication skills are essential as position is client facing

5+ years of experience in Customer master data management implementation with measurable results

2+ years of experience in project leadership, stakeholder communication, and change management

Hands-on experience with the following technical disciplines: Web Services, ETL, SQL Qualified candidates must be legally authorized to be employed in the United States.

Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Bachelor’s degree in Business/ Management Information Systems, Computer Science, Computer Engineering, Math, Mechanical Engineering, or other similar degree or commensurate work experience

Nice to Have: Knowledge and applicable work experience in the Pharmaceutical / Life Sciences

industry Experience with Force.com, APEX

IND123 Company Description Veeva Systems is a leader in cloud-based business solutions for the global life sciences industry. Committed to innovation, product excellence and customer success, Veeva has over 150 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Founded in 2007, Veeva is a privately held company headquartered in the San Francisco Bay Area, with offices in Philadelphia, Barcelona, Budapest, Paris, Beijing, Shanghai and Tokyo. For more information, visit www.veevasystems.com.

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Additional Information Posted:May 13, 2013 Type:Full-time Experience:Not Applicable Functions:Consulting, Project Management Industries:Computer Software, Information Technology and Services, Pharmaceuticals Employer Job ID:okbsXfwE Job ID5694154 ********************************************************* Apply on company website Manager, QC In-Process BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY The QC In-Process Manager is responsible for providing technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of biochemical and microbiological methods and routine In-Process testing. The position requires thorough knowledge and experience with HPLC, PCR, gel electrophoresis, enzyme kinetics, spectrophotometry, spectrofluorometry, other similar analytical tools and/or basic knowledge and experience with endotoxin, bioburden, rapid microbial testing as well as developed supervisory, organizational, and project management skills. It is expected that the incumbent will supervise senior supervisor, supervisor and four to five QC analysts and also work independently under minimal direction while accomplishing the timely completion of assignments. Good written and verbal communication skills are essential. Work activities will include, but are not limited to, participating in the preparation of sections of INDs, NDAs, BLAs, and in PAIs, reviewing routine testing results, preparing protocols and reports, performing UER, OOS and deviation investigation, providing cGMP and technical development for the staff, and interfacing with other internal and partner departments relative to quality issues. The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. RESPONSIBILITIES 1. Provide technical expertise, leadership, and perform analyses of Manufacturing and Clinical Manufacturing In-Process samples under cGMP to meet specified timelines. 2. Directly supervise QC Staff. 3. Perform primary review of QC raw data and trend results. 4. Prepare protocols, summaries, and reports. 5. Act as technical resource and train other analysts in areas of expertise. 6. Maintain the laboratory in an inspection-ready state. 7. Conduct and document out-of-specification/out-of-trend result investigations. 8. Develop, optimize, validate and troubleshoot analytical test methods. 9. Draft written test procedures for new analytical methods. 10. Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary. 11. Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives. To apply: Visit http://tinyurl.com/d578vgf or www.BMRN.com Desired Skills & Experience EDUCATION PhD with at least 3 years of experience in a relevant functional area, M.S. with at least 5 years of experience in a relevant functional area, or a B.S. with at least 8 years experience in a relevant functional area (at least 2 years in Quality Control). EXPERIENCE 1. At least two years in a cGMP laboratory, Quality Control experience preferred.

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2. Demonstrate expertise with analytical methods used to assess pharmaceuticals and biologics, especially HPLC and other analytical tools. 3. Ability to work independently, managing projects and meeting established timelines. 4. Comfort with directing the activities of other staff members. 5. Computer literacy is required. 6. Experience with Microsoft Word and Excel are required. To apply: Visit http://tinyurl.com/d578vgf or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. EEO/M/F/D/V To apply: Visit http://tinyurl.com/d578vgf or www.BMRN.com Additional Information Posted:May 15, 2013 Type:Full-time Experience:Mid-Senior level Functions:Quality Assurance, Manufacturing Industries:Biotechnology Job ID:5734743 ________________________________________________ Manager, Supply Chain Planning & Scheduling BioMarin - Novato, CA (San Francisco Bay Area) Job Description SUMMARY The Manager, Supply Chain Planning & Scheduling supports and provides continuous process improvements to the Capacity, Scheduling and Material Planning activities. This role will lead Enterprise capacity analysis and planning in a multi-site production environment, oversee Supply Chain Master Scheduling for Novato operations, and take a lead role in Class-A MRP activities across the Technical Operations group. RESPONSIBILITIES • Provides critical analysis of future production requirements and assumptions and identifies labor, space and capacity requirements for the Novato, CA and Shanbally, Ireland facilities. • Leads the master scheduling activities for Supply Chain at the Novato, CA facilitiy in partnership with the Manufacturing team. • Acts as focal point for resolving site scheduling/planning issues that might occur during normal operations, by acting as the interface between Planning and Manufacturing to ensure plans are executable.

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• Ensures the accuracy and effectiveness of Item Masters, Oracle Recipes (formulas, routings), activities and resources, and encompassing all labor and material requirements related to cost of goods sold. Additionally, partner with Manufacturing Sciences to integrate production modeling tools with capacity analyses and planning & scheduling activities. • Works with subject matter expects and stakeholders to ensure that the systems and processes supports S&OP, Rough Cut and Detailed Capacity Planning, Material Requirements Planning, Translation of Requirements to Shop Floor Scheduling, Lean Manufacturing Systems, and Budget/Cost/Spend Analysis. • Analyzes and documents current and future production needs, integrating information from various departments and business functions. Provides a path to transition from current process to future processes, including measuring and reporting progress at specified intervals. To apply: Visit http://tinyurl.com/a59jfpc or www.BMRN.com Desired Skills & Experience EDUCATION • Bachelors in science, engineering or supply chain related major required • APICS certification (CPIM, CRIM, CSCP) required • Proficient knowledge of Microsoft Excel, Powerpoint and Project software required • Proficient in Operational Excellence, Lean Process development, Six Sigma tools and techniques desirable EXPERIENCE • Minimum 5 years direct experience in a Supply Chain Planning role, preferably in a pharmaceutical or biotech manufacturing organization • Experience in ERP systems required, Oracle highly desirable • Capacity Planning, Master Production Scheduling, Shop Floor Scheduling, Material Resource Planning, Demand Planning, and Inventory Management experience required • Working knowledge of current GMP/GCP regulations required • Experience leading project teams with a proven ability to lead change and influence activities across the Company To apply: Visit http://tinyurl.com/a59jfpc or www.BMRN.com Company Description BioMarin develops & commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme(R) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan(R) (sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse(TM) (amifampridine), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, & BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers. EEO/M/F/D/V To apply: Visit http://tinyurl.com/a59jfpc or www.BMRN.com Additional Information Posted:May 15, 2013 Type:Full-time Experience:Mid-Senior level

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Functions:Supply Chain Industries:Biotechnology Job ID:5734673 ****************************************************** Apply on company website Senior Director of Manufacturing Cepheid - US - Sunnyvale, CA (San Francisco Bay Area) Job Description The Senior Director of Manufacturing is responsible for directing the development and implementation all activities related to Manufacturing and develop departmental goals based upon corporate objectives. The primary objectives are to direct the Manufacturing Department, so that quality products are manufactured on time and at or below budgeted costs, while adhering to all appropriate regulatory requirements. Prioritize production schedules based on product introduction, equipment efficiency, and materials supply. Plan and administer procedures and budgets. Develop financial and resource budgeting for departments and, at higher levels, control capital expenditures and direct/indirect labor. Overall responsibility and accountability for regulatory compliance in Manufacturing.

Responsible for meeting production requirements, yield and cost standards, through managers and supervisors. Assist in assuring that products are manufactured according to cGMP.

Responsible for ensuring that processes, equipment and the facility meet applicable Quality and Regulatory requirements.

Develop the Production plan with the Planning group, and establish procedures for maintaining high quality standards to ensure that products conform to established customer and Company quality standards.

Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.

Ensure that organization structure, resources, facilities and capital equipment are available to meet long-term production forecasts.

Represent the Manufacturing Department on multi-disciplinary teams and committees, such as MRB. Empowered to commit resources and recommend changes on behalf of Manufacturing.

Provide leadership and strategy in the hiring, development, motivation and performance review for the department, including empowering managers and supervisors to make decisions and initiate actions.

Responsible for maintaining an environment where employees take individual responsibility for sustainable safety and quality in all aspects of their job.

Active champion of productivity improvement efforts to deliver future company goals. Work on complex issues where analysis of situations or data requires an in-depth

knowledge of the company. Communicate the company vision and culture through words and actions, models

company values. Bachelor's degree or equivalent combination of education and experience to perform at

this level. 10+ years previous management experience, preferably in a commercial GMP

Manufacturing environment, is required. 5+ years experience in medical device, diagnostic, or other related industry is required. Must have experience working with automation line for high volume production. Strong ability to identify and trend data to formulate actionable plans and deliverables. Must understand the business model and its strategic implications, directing the

manufacturing effort accordingly.

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Must have experience assuming ownership for significant product responsibilities and manufacturing processes.

Thorough understanding of manufacturing cost methods/models required. Thorough understanding of operation of clean rooms, Good Manufacturing Practices

(GMP) and Quality System Regulations (QSR). Ability to respond to common inquiries or complaints from customers, regulatory

agencies, or members of the business community. Ability to effectively present information to top management, clients, customers, and

the general public, and/or boards of directors. Ability to interpret and analyze statistical data and financial reports, understand and

resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting.

Additional Information Posted:May 14, 2013 Type:Full-time Experience:Director Functions:Engineering, Management, Manufacturing Industries:Biotechnology Employer Job ID:3562 Job ID:5720832 **************************************************** Apply on company website Product Support Specialist ZELTIQ - San Francisco Bay Area Job Description Product Support Specialist I Reports To: Manager, Product Support Department: Customer Care FLSA: Non-exempt Date: 4/30/2013 Summary: As a Product Support Specialist you will be required to align yourself with the ZELTIQ service strategy and goals. Providing world class product and service support to all ZELTIQ customers and distributors worldwide. This position will require well rounded product support experience. Further it requires exemplary multitasking support skills. Essential Duties and Responsibilities include the following (other duties may be assigned.):

Provide first and second tier product support via phone, email, online web tools. Open and handle multiple service calls daily. Write and communicate on customer

failure reports and technical inquiries in a timely manner. Facilitate log retrievals from customer systems and assist with log processing and

analyzing. Conduct service call reviews and customer follow up calls daily. Process product RMA’s. Coordinate product replacement logistics. Handle direct communication with logistics

partners. Track service shipments and communicate status to customers and support & sales

team. Handle all aspects of warranty and non-warranty service issues. Draft and facilitate review of post product failure follow up letters to US/CAN customers.

Mail approved letters along with technical support surveys. Track and file incoming field service reports. Execute warranty expense data entry.

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Handle non-warranty repair quotes and logistics. Proactively seek ways to improve the coordination of global service & support activities.

Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies. Perform other related duties as assigned. Desired Skills & Experience Qualifications: Associate’s degree preferred or equivalent combination of education and experience. 1-3 years related experience required. Previous customer and product support experience for a medical device company desired. Previous experience in handling service calls in a timely manner. Excellent interpersonal skills; well organized, detail oriented; strong oral and written communication skills; previous experience in conducting basic troubleshooting of medical devices and accessories via phone and email; excellent multitasking and organization skills. Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint and Access). Highly motivated and dedicated individual. Additional Requirements: Valid driver’s license issued by the state in which the individual resides; good driving record. Preferred: Experience working in a medical device environment a plus. Experience with CRM (Customer Relationship Management) systems, mainly SAP Business One. Company Description Founded in 2005, ZELTIQ® is a global medical technology company focused on developing and commercializing products utilizing our proprietary controlled-cooling technology platform. Our first commercial product, the CoolSculpting® System, selectively reduces stubborn fat bulges that may not respond to diet or exercise. ZELTIQ has exclusive rights to this innovative, “cool” approach to permanently removing fat. CoolSculpting is cleared for marketing in the United States. We also have received regulatory approval or are otherwise free to market CoolSculpting in 46 international markets. Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Customer Service Industries:Medical Devices, Health, Wellness and Fitness Job ID:5626456 *********************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5559457&trk=jobs_seeking_view_job&goback=%2Evjs_5720832_*2_*2_*2_false_*2_*2 Associate Director, Manufacturing Operations & Validation KaloBios Pharmaceuticals, Inc.- San Francisco Bay Area Job Description The Associate Director – Manufacturing Operations & Validation will be responsible and accountable for oversight of global third-party manufacturing vendors. This position ensures consistency of production of drug substance to finished product as well as managing the relationship between the contract manufacturing organization (CMO) and KaloBios. CMO oversight will include start-up and on-going performance of CMO’s ensuring implementation of strategic initiatives that meet KaloBios’s requirements for quality, compliance, delivery and costs. Responsibilities Include:

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Responsible for managing technology transfer to contract manufacturers. This includes activities related to production of stability/clinical batches, scale-up, validation and commercial production.

Assist in the preparation of regulatory documentation for IND and NDA submissions. Coordinate logistics of commercial production and shipping at contract manufacturing

sites. Plan and oversee all activities related to the GMP manufacture of KaloBios products. Manage external contract relationships as they related to supply chain management,

product manufacturing and product distribution. Primary liaison for day-to-day decision making, evaluation and resolution of issues

between KaloBios and the CMOs. Oversee and provide guidance to CMOs to ensure quality of production. Assist with negotiation of contracts and agreements, including development of

performance indicators and compliance requirements. Provide management with timely, reliable, and structured reports regarding CMO

performance, variance analysis and contingency plans for corrective measures. Desired Skills & Experience BS/MS in Chemical, Biochemical or Pharmaceutical science, or equivalent, and minimum of 10+ years relevant experience in the following areas:

5+ years management experience in a CMC discipline such as process development, formulations, etc. for biologics drugs

Good working knowledge of pharmaceutical cGMP’s and quality systems (including international)

Good working knowledge of Quality by Design (QbD) principles and study conduct Experience in validation of biologics drug substance and/or drug product manufacturing

process Contract manufacturing experience required, as well as demonstrated experience in

establishing and maintaining supplier/contractor relationships Knowledge and experience of cost of goods management and corresponding financial

impact on business decisions. Proven success in leading multi-disciplinary project teams with excellent

communication, problem-solving and critical-thinking skills. Requires excellent written and oral communication skills. Must be willing to travel up to 25% time. Energetic person with ability to prioritize and work on multiple projects at the same

time. Must be highly organized, flexible, and a team player. Computer proficiency, outstanding organizational, and analytical skills.

Company Description KaloBios Pharmaceuticals, Inc. is developing a portfolio of proprietary, patient-targeted, first-in-class monoclonal antibodies (mABs) designed to significantly improve the lives of seriously ill patients with difficult-to-treat diseases. For more information on KaloBios Pharmaceuticals, Inc., please visit our website at www.kalobios.com. KaloBios Pharmaceuticals, Inc.Additional Information Posted:April 29, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Manufacturing Industries:Biotechnology Job ID:5559457 Veteran Commitment

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KaloBios Pharmaceuticals, Inc. commits to hiring returning veterans. **************************************************** https://jobs.smartbrief.com/action/listing?listingid=69FDA47D-4404-4DBB-8BC8-5824460D8DB5&briefid=3e572e18-3fbc-11d5-ad13-000244141872&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Sr Business Compliance Specialist Allergan Job Description This position is responsible for assisting the Vice President, Deputy Compliance Officer in providing guidance and support regarding Commercial, R&D and Medical Affairs activities associated with Allergan’s US Healthcare Compliance Program. Job responsibilities include assisting in the collection and maintenance of documentation for certain business activities, including sponsorships and consulting arrangements. In addition, this position will assist the Vice President in reviewing and updating any applicable policies and procedures, developing and conducting necessary training, and preparing all applicable state marketing/transparency reports, as necessary. Key Duties and Responsibilities:

Assists in the collection and keeping of documentation regarding certain business activities, including sponsorships, advisory boards, other HCP/HCI consulting arrangements and charitable contributions. Participates in the review and approval of such activities, among other compliance-related reviews and approvals, as necessary.

Assists Vice President with necessary advisement and guidance regarding Allergan’s US Healthcare Compliance Program. Provides timely, competent and efficient advice and support for questions and concerns regarding the compliance program, including addressing employee complaints and concerns. Liaise with sales, business operations, marketing, R&D and medical affairs departments in all compliance-related activities. Provide training assistance to teams, as needed.

As necessary, monitors state law initiatives for pending changes. Helps prepare applicable state marketing/transparency reports. Helps prepare compliance reports for review by senior management and oversight committees in support of Allergan’s US Healthcare Compliance Program.

Assists in ad hoc projects related to general corporate compliance concerns and issues, including developing compliance required policies, documents, deliverables and training.

Education and Experience: BA/BS 2-3 years healthcare compliance experience, preferably in the pharmaceutical or

medical device industries. Awareness of federal fraud and abuse laws and guidances, including the ACCME

guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including FDA, OIG, PhRMA and AdvaMed.

Essential Skills and Abilities: Exceptional communication skills, including presentation capabilities, interpersonal skills

and conflict resolution. ********************************************************** Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this job.

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Associate Research Scientist II – Contract (San Francisco Bay Area) To view job description and other current positions please visit http://jgbbiopharma.com/jobs/. DESCRIPTION: • Verify and validate product design and performance during the product development cycle. • Products may include assays, instrumentation and workflow procedures for Genetic Analysis. • Prepare samples for analysis on company DNA sequencers, especially the 3130 and 3500 instruments. • Operate and maintain company DNA sequencer instruments. EXPERIENCE AND QUALIFICATIONS: • Candidates must possess relevant experience with Molecular Biology techniques and operation of instrumentation for biological research for DNA sample concentration analysis. • Experience preparing DNA samples for sequencing reactions from thermal cycler amplification through sequencing reaction purification. • Experience performing gel electrophoresis, genotyping analysis based on generated data. • Experience documentation of runs performed and results • Experience working with regulated products is desired. • Experience with the development of testing, measurement and characterization methods of equipment and systems, and troubleshooting skills are also desired. • Experience in statistical and data analysis is a plus. • A minimum of 0 - 2 years industrial experience (B.S.) is required for this position. • Good communication skills are required. • Bachelor’s degree in Molecular Biology, Biochemistry, Chemistry, Chemical Engineering, Bioengineering, or a related field. **************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5698921&trk=eml-anet_dig-b_premjb-ttl-cn&ut=1K-tYFigOidRM1 Posted by Terry-Anne Andrews,Human Resources Manager Chemist II (Purification) AnaSpec - Fremont, CA (San Francisco Bay Area) Job Description

Perform peptide purification using various preparative HPLC and peptide analysis by analytical HPLC and MALDI-TOF mass spectrometry

Perform post-purification procedure including lyophilzation Prepare product datasheets and properly document all work-order related records. Comply with SOPs in all aspect of work. Manage other duties as assigned.

Desired Skills & Experience BS or equivalent in science with 0-3 years' experience. Perform laboratory experiments in a consistent, reliable, and accurate manner. Excellent verbal and written communication skills Able to use basic computer programs, including, but not limited to Microsoft Office

(Word, Excel). Must be a highly motivated, organized and responsible individual that is willing to learn

new techniques and skills Share expertise and train others to foster team development and collaboration Effective team skills and ability to understand deadline and commitments

Company Description

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AnaSpec, Eurogentec Group is a leading provider of integrated proteomics and genomics solutionsTM for worldwide life science research. AnaSpec offers expertise in peptides, detection reagents, antibodies, assay kits, amino acids, oligonucleotides, and qPCRs. AnaSpec carries a broad product line of biochemicals and reagents for basic research, high-throughput screening and drug discovery. AnaSpec also provides premier custom services including peptide synthesis, antibody production, assay development, fluorescent dyes, and oligonucleotide synthesis. AnaSpec is certified to ISO 9001:2008. Additional Information Posted:May 13, 2013 Type:Full-time Experience:Mid-Senior level Functions:Production Industries:Biotechnology Compensation:Competitive Salary and Benefits package Job ID:5698921 ********************************************************* Apply on company website IT Senior ETL/Reporting Analyst Pharmacyclics - San Francisco Bay Area Job Description Reporting to Executive Director, IT Enterprise Applications, the ETL/Reporting Analyst works with corporate IT to design, develop, test, maintain and support complex data extracts, transforming as per business rules and load (ETL) programs for the enterprise reporting data marts (i.e. commercial) using Informatica. There will also be a strong emphasis on Business Intelligence and developing reports / dashboards using SAP Business Objects and visualization tools. Key Accountabilities/Core Job Responsibilities:

Design, develop and organize complex Informatica mappings, sessions and workflows. Interface with business and functional teams providing strong analytical and problem

solving skills. Develop technical design documents and mappings specifications to build Informatica

mappings to load data into target tables adhering to the business rules. Analyze source data for potential data quality issues and address these issues in ETL

procedures. Actively participate in design and analysis sessions with Architects to ensure solid

designs. Work closely with the platform leads to apply standards and evolve process to ensure

solutions abide by best practice principles. Design and develop Extract Transform and Load (ETL) solutions for complex functional

and technical requirements using Informatica Conduct code reviews and quality control of all deliverables. Translate ETL logic into test plans and scenarios. Contribute to testing, dynamic debugging and performance tuning of any ETL

bottlenecks. Support system and user acceptance testing activities. Complete technical documentation to ensure system is fully documented. Define and develop key performance metrics and ensure dashboards, analytics, and

reports are providing value from a decision-support perspective using tools such as SAP Business Objects and visualization/dashboard tools

Assist with the management and prioritization of Business Intelligence (BI) requirements and ensure customer satisfaction by meeting business requirements in a timely manner

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Develop functional design documents for corporate reporting of Finance data Assist in the establishment of a Data Governance Council and best practices and

procedures for BI tools and architecture Ability to make dashboards and reports available on mobile devices.

Desired Skills & Experience Bachelor's degree in business, computer science or related discipline 10 years minimum experience in the Information Technology field 3-5 years of experience working with Informatica PowerCenter 3+ years experience working with reporting solutions such as SAP Business Objects Experience developing Business Intelligence solutions Strong knowledge of reporting and OLAP and SAP Business Objects in particular Knowledge of Commercial Biotech business processes is a major plus Self-motivated with high degree of initiative and excellent follow-up skills, along with

strong analytical and problem-solving skills Well organized, results oriented and eager to tackle difficult problems Ability to communicate and work effectively with field-based and non-technical users Good documentation skills, design functional specifications, test scripts, and training

documents Strong verbal and written communications skills, able to present information and make

recommendations to management and individuals Effectively communicate and coordinate with internal customers, vendors, and others,

as necessary Company Description Company Description Pharmacyclics (PCYC) Inc. is a mid-size biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our pharmaceutical drug development candidates are designed to target key biochemical pathways involved in human diseases with critical unmet needs. Currently we have three drug candidates in clinical development and several molecules in preclinical development. This job candidate will focus on Ibrutinib/PCI-32765, first-in-human, oral therapy that is a selective, irreversible Bruton's tyrosine kinase (BTK) inhibitor being investigated in B-cell hematologic malignancies. PCI-32765 has initiated Phase 3 in CLL and demonstrated exceptional Phase 2 efficacy and safety data, with Overall Response Rates in the range of 60-90 % and a favorable safety profile in clinical trials. Additional Information Posted: May 10, 2013 Type: Full-time Experience: Executive Functions: Other Industries: Biotechnology Job ID: 5685413 ************************************************************* Seeking a General Counsel - SF Bay Area - Diagnostics (retained) - Please contact me at denali@sanfordrose.com for additional info. Thanks! ********************************************************** If you or someone you know is qualified and interested please contact me privately at dave@alpinesearch.net Dave Murphy The Alpine Group

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Marketing Director - Medical Device, SF Bay area A high-growth, mid-size client of mine has asked me to help them hire a Marketing Director to lead a small product management team in the Class II Medical Device market. The company grew 17% last year and is likely to exceed that this year. This is a Global role with a mix of upstream and downstream work, and although the focus in on Healthcare Professionals, there is a significant DTC / Patient marketing component to the role. Qualifications: - 10+ years of marketing experience in the Medical Technology industry - 2+ years of direct supervisory experience of marketing personnel - Healthcare Professional experience is required; additional patient / consumer marketing experience is strongly preferred - A broad set of marketing skills, including segmentation, positioning, branding and lifecycle management. Prior P&L responsibility is preferred - MBA or similar degree is strongly preferred They pay well and offer equity, along with assistance for relocation (the job is based in the SF Bay area, in the South Bay ********************************************************** CONTACT: Janet Jarboe, Principal FOR COMPLETE JOB DESCRIPTIONS Jarboe & Associates Janet@JarboeAssociates.com 970-686-5899 (OFFICE) 970-689-2962 (MOBILE) SERVING PROFESSIONALS SINCE 1997 - CONFIDENTIAL SERVICES Senior Process Development Engineer, Corneal Implant - San Francisco, CA The successful candidate will be responsible for process scale-up, process equipment identification, the design of process fixtures and tooling, and conducting experiments to establish process parameters and process capability for a manufacturing process for an implantable biodegradable medical device. The candidate is expected to play a major role in designing and developing a full-scale commercial production process. Participate in process equipment IOQ, process performance evaluation, and write validation reports Responsible for tech transfer to commercial production site(s) Involved in clinical production activities such as preparing SOPs, batch records, and hands-on GMP production Perform product testing, product performance verification and validation activities. Take responsibility for designing and executing experiments. Author protocol and test reports. Assist in Design Control activities involved with medical implant. Requirements: The ideal candidate will be a biomechanical, biomedical, or medical engineer with 10 plus years of experiences in medical device industry. Candidates with strong process engineering backgrounds in contact lens or intraocular lens (IOL) industry are highly desirable. Candidates shall have a strong background in mechanical engineering, CAD, and SolidWorks. Backgrounds in electric engineering, automation, robotics, and protein biochemistry a plus. The candidate shall be familiar with cGMP and working in a regulatory environment. The ideal candidate shall have a minimum education level of BS degree. MS, PhD preferred. Candidates with a BS degree yet strong industrial experiences will still be considered. ___________________________________________________________________ Director Regulatory Affairs - CO

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•BS (prefer advanced degree; PhD in Life Science or PharmD) plus training in regulatory affairs •10+ years pharmaceutical or biotech industry experience in drug development; including 7+ years of regulatory affairs experience •Experience in oncology development is desirable; •Experience managing; mentoring; growing and leading a team of regulatory professionals •Experienced in preparing / reviewing regulatory IND/CTA and CTD NDA paper and/or electronic submissions •Collaborative team player that can establish and maintain effective working relationships with other departments, reg agencies and outside vendors •Excellent interpersonal skills with knowledge of negotiations; influencing and conflict management to assure effective interactions within and across departments •Proficiency with Word and PowerPoint is required. Experience with Excel and MS Project is desired. •Ability to contribute extensive regulatory expertise and advice •Experience interacting with the FDA; Health Canada and European regulatory agencies desired •Excellent writing skills required ___________________________________________________________________ Director Regulatory Affairs – CMC - CO • Degree in chemistry or other scientific discipline (graduate degree is preferred) plus training in regulatory affairs • 10 years or greater in the pharmaceutical industry with a minimum of 5 years in CMC regulatory • Ability to contribute extensive regulatory CMC expertise and advice • Experienced in preparing / reviewing regulatory IND/CTA and CTD NDA paper and/or electronic CMC submissions • Experience with anti-cancer oral and injectable products is a plus • Collaborative team player that can establish and maintain effective working relationships with other departments, regulatory agencies and outside vendors and act as an effective and persuasive spokesperson on CMC regulatory issues for assigned projects • Detail-oriented with good oral and written communications skills, able to supervise the preparation of accurate, clear and concise reg documents • Maintain a strong working knowledge of FDA and ICH guidelines and the application of these guidelines to the CMC portion of regulatory submissions • Experience interacting with the FDA, Health Canada and European regulatory agencies desired • Proficiency with Word and PowerPoint is required. Experience with Excel and MS Project is desired. ___________________________________________________________________ Manager or Sr. Manager Regulatory Affairs (2 openings) - CO • BA/BS degree in a scientific/health sciences discipline • 5-7 years experience in pharmaceutical Regulatory Affairs (level will be determined by experience) • Experience in the management and preparation of regulatory agency submissions • Experience working with regulatory agencies • Oncology experience a plus •Ability to communicate effectively (written and verbal) and adapt to a changing environment ___________________________________________________________________ Director/ Associate Director; Quality Assurance - CA (Mandarin skills) Bachelor's degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 7 years experience in QA oversight of pharmaceutical development and manufacturing. Ability to fluently speak, read and write Mandarin.

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Small molecule experience. Experience with API & chemical drug product manufacturing QA oversight of manufacturing of (CTM) and Commercial Products. Practical knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release. Working knowledge of US and EU cGMP regulations and guidelines. Experience in auditing suppliers and CMO’s. Strong planning and time management skills and ability to prioritize own work. Strong leadership and influencing skills a must. Knowledge of regulatory compliance of medical device manufacturing a plus. Some travel required. ************************************************************ Nancy Symonds at njs@nancysymonds.com SR. MANAGER QA SYSTEMS for a DEVICE company. Must have Class III experience, design control and operations experience in addition to Compliance, Systems, CAPA, Documentation. Will manage 2 experienced QA staff. Company is very small (11 employees) so will be a very hands-on role. Reports to a VP. Interested individuals may contact me at njs@nancysymonds.com. Please forward this to your QA device colleagues here in the Bay Area. Thanks. ******************************************************* Contact information: Donna Kato email address: donna@regprofessional.com. Executive Secretary – South Bay –work in house Regulatory Professionals, Inc (www.regprofessional.com) is looking for an Executive Administrative Asst. who has had 7 - 10 yrs prior experience supporting a VP or above. Must be proficient in MS MS Outlook, Word Power Point and Excel. Must have had prior experience in a pharma/biotech co. - preferably Reg. Affairs, Clinical, or QA departments. Must have good interpersonal skills, is well organized, can multi-task, can manage calendars, can work independently, is flexible, and is a problem solver. If anyone knows an Executive Administrative Asst. who is looking for an opportunity, please feel free to have the individual contact Donna directly. *************************************************** https://jobs.smartbrief.com/action/listing?listingid=78EC80D2-E057-4F63-8611-8ECC7B1A626B&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Principal Systems Engineer IRIS International, Inc Job Description Description: IRIS International, Inc. is a leader in in vitro diagnostic urinalysis systems, digital imaging software development, sample collection, sample processing and small benchtop centrifuges and supplies for chemistry, coagulation, cytology, hematology, and urinalysis for the clinical and veterinary markets. The Company operates through its Iris Diagnostics division, and its

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Iris Sample Processing (formerly Statspin®) subsidiary. The Company's stock trades on the NASDAQ under the symbol "IRIS". We have a growth opportunity for a Principal Systems Engineer in our Chatsworth, CA corporate office. If you have the skills and experience described below - we are looking for you! IRIS International is a great place to work, has excellent benefits and will offer the right individual an incredible career opportunity. Job Summary: The successful candidate will participate in and lead the development of in vitro diagnostic (IVD) instruments that provide rapid and accurate diagnostic test results in clinical laboratories worldwide. Responsibilities/Duties: · Lead cross-functional engineering team · Define and develop System Architecture · Perform system modeling and analysis · Translate customer needs into engineering requirements · Decompose and allocate system level requirements into subsystem level requirements · Develop performance specifications · Develop system level control algorithms and timing · Perform Risk Analysis · Write verification and validation plans, protocols and reports · Perform and manage the execution of verification and validation testing · Transfer designs to manufacturing Required Experience: 10+ years experience with a life science company preferably in vitro diagnostics or medical devices. Any combination of patents, documentations, publications, methods improvement, instrumentation, and techniques totaling 10. Experience documenting and presenting written and oral reports including memos, technical reports, and presentations. Has made major contributions to the introduction of a new product or process resulting in significant cumulative increased sales, savings or value. Specific Skills/Knowledge: · Project management · Stage gate product development processes · FDA and ISO design controls · Logic timing diagram interpretation, mathematical and statistical analysis. Required Education: Advanced degree in Engineering or Physics ***************************************************

Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions

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Contact cheryl@biophaseinc.com if interested!

Analytical Chemist - Method Development (Sacramento)

BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for an Analytical Chemist - Method Development to work for a leading Bay Area biotechnology company. Analytical Chemist - Method Development BioPhase is recruiting for a direct hire position for an Analytical Chemist-Method Development. This is with a pharmaceutical related company in Sacramento, CA. Relocation is possible! Responsibilities: Candidate will plan and execute independently assigned tasks such as method development, transfer and validation; provide analytical support to the research and development group to meet project goals; select appropriate methods and techniques in performing experiments; collaborate with senior personnel and/or manager to develop routine analytical methods; work cross functionally to achieve target goals; proactively seek out potential solutions to issues; attend project meeting to assure that all client analytical requirements are met; serve as a resource to other researchers involved in project. Assure a positive transition of developed and validated methods to the quality control department personnel; conduct peer review and method approval. Candidate will also be responsible of creating method validation and/or qualification protocols and reports as well as analytical methods; perform all lab work that will support method validation, transfer, and qualification; perform qualification of primary and secondary reference material to be used as analytical standards. Must have knowledge of ICH guidelines in method validation. Must understand the requirements for methodology transfer. Requirements: BS in Chemistry or related field, and at least 4 years experience in method development/validation/transfer, or an MS and at least 3 years of relevant experience in a cGMP environment Strong interpersonal and verbal communication skills Ability to excel in a team-oriented environment and to use common tools for effective scientific communication within the company Knowledge of the following instrument: LC/UV/DAD/MS, FTIR, GC, GC/MS, NMR, and KF Contact cheryl@biophaseinc.com if interested!

************************************************ https://jobs.smartbrief.com/action/listing?listingid=0519C623-C4AC-45B1-BDBB-F99BA874B380&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Senior Software QA Engineer IRIS International, Inc. Job Description

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IRIS International, Inc. is a leader in in vitro diagnostic urinalysis systems, digital imaging software development, sample collection, sample processing and small benchtop centrifuges and supplies for chemistry, coagulation, cytology, hematology, and urinalysis for the clinical and veterinary markets. The Company operates through its Iris Diagnostics division, and its Iris Sample Processing (formerly Statspin®) subsidiary. We have a growth opportunity for a Senior Software QA Engineer in our Chatsworth, CA corporate office. If you have the skills and experience described below - we are looking for you! IRIS International is a great place to work, has excellent benefits and will offer the right individual an incredible career opportunity. Basic Job Function: The successful candidate will evaluate and test new or modified software programs and software development procedures used to verify that programs function according to specified requirements and conform to establishment guidelines by performing the duties listed below. Responsibilities/Duties Performed: • Analyzes, designs, codes, and tests review requirements, designs, and implementations to determine whether requirements are met and adhere to guidelines. • Creates and modifies test procedures to attain system quality economically and efficiently. • Recommends program improvements or corrections to programmers. • Tests procedures and analyzes systems to discover system errors. • Uses creative and critical thinking skills to perform ad-hoc testing to discover system errors. • Measures and characterizes system performance using engineering skills. • Writes documentation to describe program evaluation, testing, and correction. • Test, track, and verify defects in systems using software and other applications • Creates and/or modifies software applications or utilities to test, track, and verify defects in systems using programming skills • Creates and maintains overall test plans • Validates trouble reports and develops repeatable error scenarios. • Produces release documentation for document control. • Provides technical assistance by responding to inquiring from other regarding errors, problems, or questions about problems, or questions about programs.

• Trains end users or technical support staff to use programs. • Mentors department members. • Provides leadership for software QA team • Develops and maintains plans for QA improvement • Establishes QA standards • Any other duties as assigned.

Required Experience: • Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or Electrical Engineering plus six years of relevant experience or Master’s degree with four years of relevant experience. • Experience in automated test execution required. Microsoft Test Manager preferred. • Experience developing test procedures. • Service/instrument testing preferred.

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Specific Skills/Knowledge: • Familiarity with testing and test equipment such as DVMs, power supplies, and oscilloscopes. • Familiarity with common communication protocols like Ethernet and serial. • Microsoft TFS a plus. • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. • Ability to write reports, business correspondence, and procedure manuals. • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. • Ability to apply mathematical operations or use off-the-shelf software for such tasks as frequency distribution compilation, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Required Education: Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or Electrical Engineering plus six years of relevant experience or Master’s degree with four years of relevant experience as stated above.

*************************************************** Candidates can contact me this evening or at my work email, howie@spinalmodulation.com

Contract Electrical Engineer at Spinal Modulation

Spinal Modulation needs a contract Electrical Engineer. This person would need to work with both manufacturing and development departments, as we make improvements to our implantable neurostimulator. Candidates can contact me this evening or at my work email, howie@spinalmodulation.com.

********************************************************************

Wirth & Associates is a Pharmaceutical, Biotech and Medical Device Executive Search Firm. Below is a list of our current openings, if you have any referrals or you need people please contact our office for more information. Please email wirth@wirth-associates for detailed job descriptions. Senior Director, Network Capacity 76M-051413-l6N The Primary responsibility of this role will be to establish a Capacity Analysis Group (CAG) that will develop, execute and maintain a dynamic system that will provide users accurate Capacity utilization and constraint report in real time across the network. *This position requires Knowledge on various pharmaceutical dosage forms and technologies. It also has an element of Project Management.

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Manager, Quality Operations - I82-050613-MP22 Essential Duties and Responsibilities: Develops and maintains quality assurance goals and objectives that are complementary and support corporate policies and goals. Performs quality assurance review of design documentation to ensure compliance with stated requirements, including company quality records (SQARs, master MBRs, study protocols, PDRs, etc.) Director of Quality Assurance - 76J-041913-76C This individual will oversee a large and diverse Quality Assurance organization for a 2000 person Class II/III medical device operation for a very large medical device/pharmaceutical firm. Qualified candidates will have device QA leadership experience in documentation, investigations, quality systems development and implementation, risk management, internal/external/supplier auditing, validation, device recalls, ISO 13485, and allied areas. DIRECTOR OF QC LABORATORIES 67J-0515-23C Fast-paced, multi-faceted site leadership role responsible for three Quality Control Laboratories spanning testing of incoming raw materials and product release, in-process and finished goods testing, stability, methods development, transfer and validation, documentation, laboratory audits, FDA interface, lead QC portion of PAI's, investigations, CAPAs, customer interaction and allied areas. QA TECHNICAL WRITING & COMMUNICATIONS DIRECTOR - J23-0515-58C This is a very unique position with a major drug/device company that combines SME knowledge of quality assurance/compliance coupled with excellent technical writing skills. SITE QA DIRECTOR - 67-0515-66J-23C Will oversee all QA activities for a large manufacturer of terminally-sterilized drug products Manufacturing Process/Project Engineer - 12J-96C-0515 Highly visible Project Engineering role providing engineering support to Biopharmaceutical manufacturing equipment. Batch Release Manager - 44C-0515-66J We seek an experienced QA professional proficient in providing leadership in Batch Record Release and disposition of in-process commodities and final products for all site-manufactured products. *******************************************************

Jobs That Crossed My Desk Through May 13, 2013 ************************************************** Apply on company website Director, Public Health & Education - Brazil (Access Ops & Emerging Markets) Gilead Sciences - Foster City (San Francisco Bay Area) Job Description Specific Responsibilities: Gilead Sciences is a biopharmaceutical company that discovers and develops innovative medicines for life-threatening diseases. Gilead makes it a priority to increase access to these medicines for people who can benefit from them, regardless of where they live or their ability to pay. This is the focus of the Access Operations and Emerging Markets business unit,

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spanning more than 130 resource-limited low- and middle- incomes countries across Latin America, Africa and Asia. The Director, Public Health and Education will serve as the primary scientific expert for Gilead’s medicines across the Access Operations and Emerging Markets geography. The individual will establish and maintain strong scientific and clinical relationships with medical professions, researchers, NGOs, public health officials and other key stakeholders involved in treatment regionally and in-country. Outreach will be conducted in the context of the public health and socioeconomic issues impacting individual regions, countries or provinces and in alignment with Gilead’s therapeutic areas of focus. The Director will work collaboratively within the department and cross-functionally with other groups to ensure that all interactions regarding scientific and clinical education are conducted with the upmost rigor and high ethical standards. Essential Duties and Job Functions: Specific Responsibilities: • Engage in field-based scientific exchange and communication with external audiences in Gilead’s therapeutic areas of focus • Identify, establish and maintain scientific relationships with opinion leaders regarding disease-state and product-specific information • Educate NGO community and key supply agents on Gilead’s clinical and pharmaco-economic data supporting products and therapeutic areas of focus • Support the Clinical Operations organization, as needed, with Gilead-sponsored research and strengthen Gilead’s presence in the designated therapeutic areas (Cardiovascular, HIV, Liver Diseases, Antifungals) • Serve as primary liaison with potential investigators interested in conducting investigator sponsored research (ISR) • Maintain regular contact with investigators to monitor the progress of ISR • Attend and provide scientific support for Public Health and Education activities and scientific sessions at regional and national conferences • Lead and drive the medical training of in-country Public Health and Education staff and sales personnel for regional business partners Desired Skills & Experience Knowledge, Experience and Skills: • Typically requires MD, PharmD or DO degree and minimum 8 years of public health experience in a medically related field • Extensive experience in infectious disease clinical care, clinical research or both desired. • Industry experience preferred • Demonstrated ability to work within a collaborative, cross-functional environment with internal and external colleagues, including representatives of academia, research and medical communities • Strong communication skills; able to effectively present and discuss scientific data • Ability to think strategically and to align medical, public health and commercial strategies • Extensive travel required Company Description Gilead was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies.

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Additional Information Posted:April 30, 2013 Type:Full-time Experience:Director Functions:Consulting, Science Industries:Biotechnology Employer Job ID:12521 Job ID:5567674 ********************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5401643&trk=rj_em&ut=3-84cx5XI71BM1 Director of Marketing (medical device) NCompass Recruiting Services - San Francisco Bay Area Job Description Summary: Accountable for broad upstream marketing activities supporting intravascular medical device business segment. Responsible for full life cycle management of the Product Line. Actively participates in the product development and platform global strategies. Establishes key customer relationships. Develops customer requirements, and proposes new product concepts. Acts as Voice of Customer in all decisions related to products. Promotes products through conferences, literature, clinical trials, and collateral development. Benchmarks competition and stays fluent with state of the art in clinical practice. Conducts detailed analyses of the Market and Sales Performance. Crafts impactful Business Models and Marketing Plans. Presents work to Senior Leadership. Essential Functions: Product Management

Identifies market potential, establishes pricing and market strategies, estimates potential sales, introduces segment products to market, manages distribution/channel issues, and manages mature product through phase-out.

Interprets and translates scientific clinical data for commercial utilization. Defines promotional activities along with sales, publicizing the product through the

press, sales force, and alternate distribution channels. Provides expertise in intravascular product area and develops strategies and applicable

portions of the company’s business plan. Plans, organizes, and coordinates assigned programs to ensure accomplishment of

financial/budgetary goals and optimum allocation of resources. Manages resources to execute assigned programs. Coordinates program planning with customer to ensure identification of appropriate

manufacturing schedules, goals, design criteria, costs, and similar considerations. Conducts pre-contract liaison with customer and may participate in negotiating with key

customers regarding contract terms and conditions. Coordinates details of program within the organization with a wide range of functions

and individuals. Coordinates product introduction and market exploitation with marketing and sales

organizations to ensure maximum penetration of market segment. Provides continuing product surveillance and management of established product to

obtain financial objectives. Interface with Research and Development in order to ensure that product development

efforts support the primary purpose. Lead the definition of new relevant products and upgrades to existing products.

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Build an identity and establish effective positioning, working closely with Marketing Directors, Marketing Communications, Clinical Field Specialists, Sales Directors and Sales Training Staff.

EDUCATION AND EXPERIENCE Requires a bachelor's degree with an MBA preferred. At least 5+ years of Marketing experience within the medical device industry with a

majority focused on upstream responsibilities Preferred Experience:

Technical or product development background is highly preferred. Clinical Marketing, Reimbursement, and Business Development experience are all a

plus. Desired Skills & Experience Medical Device experience is required. This is an Upstream Marketing position in the cardiovascular space. Company Description NCompass is a boutique recruiting firm specializing in contingency and retained Search for Medical Device companies throughout California. We have 10+ years of experience building successful teams in both start up and large company environments. Knowing that recruiting is no longer just about sourcing, we build strategic relationships with our clients and direct the hiring process through extensive discussions with executive management and hiring managers. Our niche focus allows us to leverage our industry expertise and drive strategic hiring so that the right candidate for the job and company is found and placed in a timely manner. NCompass Recruiting Services Additional Information Posted:April 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering Industries:Medical Devices Job ID:5401643 ******************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=5611780&trk=rj_em&ut=0CNM3qJMc61BM1 VP Marketing Carl Zeiss Meditec- San Francisco Bay Area Job Description The Vice President of Marketing reports to the SVP, Sales and Service and is a member of the Sales and Service executive team. Responsible for providing executive leadership and management of CZMI’s marketing organization, which include: downstream product marketing, tradeshows, U.S. Marcom activities, and sales training. The VP Marketing will drive the CZMI’s efforts to position itself as a global leader in the medical device market and to work with sales and service to achieve its revenue goals. ESSENTIAL FUNCTIONS:

Establish the direction for the U.S. marketing organization to achieve annual sales and profit plans

Contribute to the development of the long term strategic plan and execute the local implementation.

Contribute to new product development plans and programs for Carl Zeiss Meditec Plan, organize, recruit, train and develop CZMI’s marketing personnel Develop, implement and manage annual budget, compensation plan and motivational

programs for department personnel

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Plan, organize and conduct meetings and discussion groups, including annual sales and interim sales management meetings

Develop and manage promotional plans and materials for major trade shows. Support Sales organization in upgrading, changing, motivating, managing and

maintaining “elite” distributor network Identify and develop new local strategic alliances to broaden CZMI’s commercial

opportunities Capitalize on fresh revenue opportunities; implement for maximum effect within

distribution channel. Oversee marketing communications including enforcing branding guidelines,

advertising, white papers, trade shows, seminars and events collateral materials. Define and direct marketing programs for demand creation, lead generation and

interface with Sr. Sales Management team for lead tracking and management Oversee product marketing including product launch management, sales training,

presentations, sales tools, competitive analysis and general sales support. Develop and manage the Company’s entire marketing budget. Develop and track metrics and success criteria for all marketing programs and

activities. Desired Skills & Experience

Bachelor’s degree required; MBA a plus Minimum of 10 years of progressive marketing and sales/sales management experience

in the medical device industry and 4 years of senior management experience. Capital equipment experience in the medical / surgical setting (e.g. Neurosurgery, ENT,

Ophthalmology, Dental) essential. Strong distributor sales/”downstream marketing” experience mandatory Strong marketing leadership and decision-making skills critical Successful experience managing professional staff Exceptional track record of developing and implementing marketing and sales strategies

that have consistently met or exceeded planned objectives, providing personal leadership through example.

Ability to work collaboratively with colleagues and staff to create a results-driven, team oriented environment.

Polished oral presentation and written communication skills. Good analytical skills and ability to clearly communicate policy decisions company

strategy and vision Experienced knowledge of financial analysis and analysis tools (i.e. spreadsheets, etc.) Requires 30% travel

Carl Zeiss Meditec, Inc. is an Equal Opportunity Employer (EOE) and strongly supports diversity in our workplace. Qualified external candidates may apply by submitting a resume to d.jobs@meditec.zeiss.com. PLEASE REFERENCE requisition R1375JM in the subject line. Company Description Carl Zeiss Meditec supplies innovative technologies and application-oriented solutions which enable doctors to improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat ophthalmic diseases. In the field of Neuro/ENT surgery, the Company provides innovative visualization solutions. Carl Zeiss Meditec's medical technology portfolio is rounded off by promising future technologies such as intraoperative radiotherapy. Additional Information Posted:May 3, 2013 Type:Full-time Experience:Executive Functions:Marketing

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Industries:Medical Devices Job ID:5611780 *********************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5317955&trk=rj_em&ut=0gHT6zzPU31BM1 Life Sciences Industry Marketing Principal EMC- Pleasanton, CA or Boston, MA (San Francisco Bay Area) Job Description The Life Sciences Industry Marketing Principal will support the development and execution of the go-to-market industry strategy and plan for the EMC Information Intelligence Group (IIG). As part of the IIG Product & Solutions Group (IPSG) Marketing team, this position will be responsible for solution marketing-related efforts for Life Sciences on a global basis. By delivering industry marketing expertise and in-depth insights and analysis of our market, trends and opportunities, this role will play a key role in building market awareness, developing messaging, executing solution launches, driving field and partner enablement, and other programs and activities that increase market share and impact overall revenue growth. Reporting to the Director of Market Development for Life Sciences, the role will also work closely with Product/Solution Development, IIG Corporate Marketing, Sales, and other cross-functional teams across the business to ensure full alignment and effective integration of EMC resources, programs, and activities. Desired Skills & Experience Principal Duties

Collaborate with the Director of Market Development in developing, managing and implementing a cohesive industry business strategy and go-to-market plan for Life Sciences.

Develop and educate the business on compelling, differentiated industry positioning and value propositions for existing and new solutions.

Work with key stakeholders to deliver the IIG Life Sciences portfolio strategy across products, solutions, services, and partners.

Create industry-specific content to create market awareness and demand generation campaigns/programs. Develop customer- and partner-facing assets for sales and marketing, including industry presentations/webinars, industry/solution overviews, sales presentations, playbooks, training materials, customer cases studies, and whitepapers.

Analyze market research and competitive trends to inform market segmentation, strategies, programs, new solutions and enhancements to the IIG industry portfolio.

Participate in or facilitate the participation of IIG in industry and EMC-sponsored events, including presentations, analyst briefings, press releases, tradeshow booth support, etc. Serve as IIG spokesperson and industry expert with the analysts, industry trade press, partners, and other external initiatives.

Ensure a metrics-driven approach to all industry marketing activity. Critical Hiring Criteria Skills

Knowledge and experience within the Life Sciences industry A strong understanding of and ability to clearly articulate industry challenges, trends

and market needs for enterprise content management or information management Ability to work well and manage by influence in a matrix organizations, with the ability

to cut through multiple, differing perspectives and opinions in order to execute successfully

Exceptional writing and verbal communication skills with ability to distill disparate information and perspectives into concise, relevant and impactful marketing messages and content

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Team-focused, with logistical and creative skills, have a keen eye for detail, and dedication to the success of the team and the organization.

Must be hands-on, self-starter who can manage projects/deadlines/priorities, as well as do the work required to get things done

Education Required Bachelors (Non -Technical) MBA preferred, but not required

Experience Required 10+ years relevant experience in a global enterprise technology company

Company Description EMC Corporation is the world leader in products, services and solutions for information management and storage. We are a trusted provider of information infrastructure, helping organizations of every size around the world keep digital information protected, secure, and continuously available. We are among the 10 most valuable IT product companies in the world. We pride ourselves on doing what is right and on putting our customers’ best interest first. We are EMC, where information lives. EMC is an Equal Employment Opportunity employer that values the strength diversity brings to the workplace. EMC does not accept unsolicited Agency Resumes. EMC will not pay fees to any third party agency or firm that does not have a signed "EMC Agency Fee Agreement". Additional Information Posted:April 30, 2013 Type:Full-time Experience:Mid-Senior level Functions:Product Management, Marketing Industries:Marketing and Advertising Job ID:5317955 ************************************************************** Please send or have your referrals send a resume to Evans@LegacyMEDSearch.com Evans Aguilar, 407-591-3023 Director of Operations I am working on a retained, confidential search, looking for a Director of Operations. This person should have experience with contract manufacturing in a med device company. I'm looking for someone who would also have worked with plastic injection molding. Anyone that has been through an acquisition and has the experience guiding folks through the change would potentially be a great fit for this role. Does anyone come to mind? Relocation is an option for the right candidate. ******************************************************* Apply on company website Medical Monitor (MD): Top 10 Pharma Co: Home-based West Coast: Full-time (Employee): Phase III Cardio Studies: Great Co & Benefits Cornerstone Search Group- CA (Greater Los Angeles Area) Job Description Summary: Very important Medical Monitor (MD/Physician) position that will be very involved with critical and large Phase III Cardiovascular Studies for this Top 10 Global Pharmaceutical Industry Leader. This is a full-time position where you will be an employee of this Top 10 Pharma Co., and you will be home-based on the West Coast. Company Description: A Top 10 Global Pharmaceutical Industry Leader that has an extensive early and later-stage development pipeline in multiple therapeutic areas.

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Location: Home-based position based on the West Coast (full-time/employee position where you will be a full-time employee of this Top 10 Pharma Co) Attractive Features about this Opportunity

Become a full-time employee of one of the most successful Pharma Companies in the World

Be part of a team working on critical and large later-stage (Phase III) Cardiovascular Studies

Work closely with key PIs and KOLs Home-based position where you are a full-time employee of a major Pharma Co. & you

receive their full benefits package too Receive attractive and excellent benefits including annual bonus, Long-term incentives.

Responsibilities In a nutshell, you will be an important contributor to overall success of critical and large Phase III Cardiovascular in-patient clinical studies being conducted for an important drug being developed by this Top Pharma Co. You will travel to investigational sites located in the Western USA as necessary to meet face-to-face with PIs and KOLs involved with these critical Phase III studies to help them in many areas, e.g. understanding the protocol, recruiting patients (inclusion/exclusion criteria), managing/running the studies, managing risk, answering their questions about any number of medical, safety, study management/operational matters. Requirements/Qualifications:

MD degree 5 or more years of experience working for a Pharmaceutical, Biotechnology or CRO in a

Medical Monitoring capacity Cardiovascular clinical study experience or medical training Any critical care (in-patient clinical study) experience is a plus Experience performing site feasibility studies Phase IIb and III experience Good communication and presentations skills Willingness and capability to travel as necessary to investigational sites located in the

Western areas of the USA to meet face-to-face with PIs and KOLs Confidentiality/privacy All inquiries and submissions are held in strict confidence, i.e. no information provided to us by you will be shared with any parties outside of Cornerstone Search Group without your permission to do so. Contact: Cliff Miras (initial contact via email works best) Co-founder & Managing Partner Cornerstone Search Group, LLC Specialized Pharmaceutical | Biotechnology Executive Search & Recruitment Firm 6 Campus Drive | Parsippany, NJ 07054 p 973.656.0220 x 711 | f 973.656.0228 cmiras@cornerstonesg.com | www.cornerstonesg.com Desired Skills & Experience

MD degree 5 or more years of experience working for a Pharmaceutical, Biotechnology or CRO in a

Medical Monitoring capacity Cardiovascular clinical study experience or medical training Any critical care (in-patient clinical study) experience is a plus Experience performing site feasibility studies Phase IIb and III experience Good communication and presentations skills Willingness and capability to travel as necessary to investigational sites located in the

Western areas of the USA to meet face-to-face with PIs and KOLs

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Company Description Cornerstone Search Group partners with US and Global Pharmaceutical, Biotech and other Life Sciences companies to identify and recruit professionals for their senior staff through executive management level needs. Our services include: Retained Search, Contingent Search (permanent and contract positions), and Strategic Advisory Services (e.g. org structure, recruitment strategies, compensation / benefit guidance). Cornerstone Search GroupAdditional Information Posted:May 10, 2013 Type:Full-time Experience:Director Functions:Research, Other, Science Industries:Biotechnology, Pharmaceuticals Employer Job ID:cmBH2088li Job ID:5565952 ******************************************************** http://www.ziprecruiter.com/job/Bilingual-Customer-Services-Specialist-English-Spanish/f3ec1faa/?source=social-linkedin-group-jobs Bilingual Customer Services Specialist (English/Spanish) South San Francisco, CA The Position The Client Services Specialist will be a key liaison between Veracyte and its customers. The primary responsibility is to provide world-class service and support to doctors and patients as well as to problem solve with our internal practices including sales, lab staff, and billing department to resolve customer issues. The successful candidate will be responsible for establishing and maintaining positive, successful relationships with English and Spanish speaking customers on behalf of the company by taking complete responsibility for each customer interaction and ensuring all customer requirements are fully met. Who You Are You have excellent customer service skills, a kind and compassionate approach to problem solving along with great attention to detail. You have the intellectual fortitude to manage an issue and see it through to its conclusion. You take great pride in building positive relationships with patients, doctors, sales representatives and your peers. You have extensive experience interacting with patients in both Spanish and English regarding billing concerns and a working knowledge of the insurance reimbursement process in addition to knowledge of laboratory process and procedures. You aspire to influence continuous improvement in our internal process and operations through providing customer feedback themes and ideas for solutions. You have at least two years of experience working in a customer care role at a healthcare related company and have used SalesForce CRM as well as Microsoft Office. What We Can Offer You Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We work collaboratively, offering you the opportunity to constantly learn from your colleagues – even those outside of your area of expertise. Here at Veracyte, we find fun, little ways to make it a great place to work – participate in our annual Halloween costume contest, treat yourself to free Peet’s coffee

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or the endless supply of PB&J sandwiches, and toast colleagues as we celebrate milestones. We also offer conveniences such as an on-site workout room and free shuttle service from both BART and CalTrain. We are a company with a heart and believe in positively impacting the world beyond our doors by providing our product to those who cannot afford it through a financial assistance program. Veracyte seeks the best employees and works to create an environment where they can thrive, expand their knowledge and contribute at the highest level. About Veracyte: Veracyte is pioneering molecular cytology; we are dedicated to helping people avoid unnecessary invasive procedures just to get a diagnosis and to reducing healthcare costs at the same time. We use rigorous science to unlock genomic answers from tiny numbers of cells obtained through minimally invasive methods before surgery is needed. We launched our first product the Afirma® Thyroid FNA Analysis, with a genomic test at its core in record time and have already helped save thousands of patients from unnecessary surgery due to ambiguous thyroid nodule biopsy results. Our genomic test is offered by hundreds of physicians around the country, is covered by Medicare and private payers, and is clinically validated, including in a multicenter study published in the New England Journal of Medicine. The Wall Street Journal named us to its list of top-50 venture capital-funded companies in 2011, BayBio honored us with its Fast Start award in 2012, and In Vivo: The Business and Medicine Report featured us recently as a model for how to build a molecular cytology company. _____________________________________________________________ http://www.ziprecruiter.com/job/Managed-Care-Accounts-Manager/0ffaf69a/?source=social-linkedin-group-jobs Managed Care Accounts Manager South San Francisco, CA The Position The Managed Care Accounts Manager joins the Veracyte commercial organization to build out and execute managed care contracting for Veracyte. This role will be responsible for managing network contract relationships with managed care plans, hospitals and Accountable Care Organizations (ACOs). This includes managing the credentialing and network contracting processes for Veracyte to become an in-network provider at manage care plans, developing relationships with network contracting departments to enable additional services, and functioning as an account manager to manage reimbursement metrics and follow-up for each contracted account. Partnering with the sales team on other key aspects of the role such as driving hospital contractual arrangements through to execution and supporting the development of a contracting strategy for engaging ACOs in the use of our Afirma® testing is critical for success. Who You Are You are passionate about improving patient care through the application of novel medical technology. You thrive in a fast paced environment where you have an opportunity to build from the ground up and influence managed care contracting at Veracyte. You have more than 5 years of experience with managed care contracting at a managed care company, medical device or diagnostic company, or at an insurance company. Being organized along with extensive management of data, process, and applications contributes to your strong program management skills. You are known for being an impactful account manager who can help clients realize additional value and create win-win scenarios. You have a Masters level degree or legal degree although not required for the role. What We Can Offer You

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Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We work collaboratively, offering you the opportunity to constantly learn from your colleagues – even those outside of your area of expertise. Here at Veracyte, we find fun, little ways to make it a great place to work – participate in our annual Halloween costume contest, treat yourself to free Peet’s coffee or the endless supply of PB&J sandwiches, and toast colleagues as we celebrate milestones. We also offer conveniences such as an on-site workout room and free shuttle service from both BART and CalTrain. We are a company with a heart and believe in positively impacting the world beyond our doors by providing our product to those who cannot afford it through a financial assistance program. Veracyte seeks the best employees and works to create an environment where they can thrive, expand their knowledge and contribute at the highest level. ********************************************************* Qualified and interested candidates, apply now! Contact cheryl@biophaseinc.com QC Inspector (East Bay) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Quality Control Inspector to work for a leading Bay Area biotechnology company. Quality Control Inspector BioPhase Solutions is seeking a temporary Quality Control Medical Device inspector for an immediate position with an East Bay Medical Device company. Responsibilities: Perform visual and dimensional inspections, functional tests on incoming material, subassemblies, and finished products, and provide disposition status according to defined procedures and criteria. Document results of the inspections and testing, Quality Control, tracking database, and provide feedback. Review device history records for compliance to established procedures and Good Documentation Practices. Initiate Non Conformance Reports as necessary and participate in complaints resolution. Prepare quality control reports as necessary. Assist in the drafting and revision of operating procedures and data tracking forms related to inspection. Requirements and Experience: High School Diploma or equivalent experience in a Life Science Curriculum (Biochemistry, Chemistry, Materials Science, or Medical Devices). 2+ years of experience within an industrial environment, in a FDA and or ISO regulated medical device quality setting. Industry experience with cGMP. Hands on experience with microscopy or microscope observations, measuring tools and standard biotech laboratory equipment and practices. Excellent English verbal and written communication skills. Proficiency with MS Word, Excel and PowerPoint. Must possess extreme attention to detail and organization in all aspects of work, learn and apply new skills quickly

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Ability to effectively document procedures, processes, and results, use basic data analysis, work collaboratively with a team, and handle multiple competing priorities in a fast-paced work environment. Experience in an aseptic environment or with blood handling is a plus. **************************************************** https://jobs.smartbrief.com/action/listing?listingid=0519C623-C4AC-45B1-BDBB-F99BA874B380&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Senior Software QA Engineer IRIS International, Inc. Job Description IRIS International, Inc. is a leader in in vitro diagnostic urinalysis systems, digital imaging software development, sample collection, sample processing and small benchtop centrifuges and supplies for chemistry, coagulation, cytology, hematology, and urinalysis for the clinical and veterinary markets. The Company operates through its Iris Diagnostics division, and its Iris Sample Processing (formerly Statspin®) subsidiary. We have a growth opportunity for a Senior Software QA Engineer in our Chatsworth, CA corporate office. If you have the skills and experience described below - we are looking for you! IRIS International is a great place to work, has excellent benefits and will offer the right individual an incredible career opportunity. Basic Job Function: The successful candidate will evaluate and test new or modified software programs and software development procedures used to verify that programs function according to specified requirements and conform to establishment guidelines by performing the duties listed below. Responsibilities/Duties Performed: • Analyzes, designs, codes, and tests review requirements, designs, and implementations to determine whether requirements are met and adhere to guidelines. • Creates and modifies test procedures to attain system quality economically and efficiently. • Recommends program improvements or corrections to programmers. • Tests procedures and analyzes systems to discover system errors. • Uses creative and critical thinking skills to perform ad-hoc testing to discover system errors. • Measures and characterizes system performance using engineering skills. • Writes documentation to describe program evaluation, testing, and correction. • Test, track, and verify defects in systems using software and other applications • Creates and/or modifies software applications or utilities to test, track, and verify defects in systems using programming skills • Creates and maintains overall test plans • Validates trouble reports and develops repeatable error scenarios. • Produces release documentation for document control. • Provides technical assistance by responding to inquiring from other regarding errors, problems, or questions about problems, or questions about programs.

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• Trains end users or technical support staff to use programs. • Mentors department members. • Provides leadership for software QA team • Develops and maintains plans for QA improvement • Establishes QA standards • Any other duties as assigned. Required Experience: • Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or Electrical Engineering plus six years of relevant experience or Master’s degree with four years of relevant experience. • Experience in automated test execution required. Microsoft Test Manager preferred. • Experience developing test procedures. • Service/instrument testing preferred. Specific Skills/Knowledge: • Familiarity with testing and test equipment such as DVMs, power supplies, and oscilloscopes. • Familiarity with common communication protocols like Ethernet and serial. • Microsoft TFS a plus. • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. • Ability to write reports, business correspondence, and procedure manuals. • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. • Ability to apply mathematical operations or use off-the-shelf software for such tasks as frequency distribution compilation, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Required Education: Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, or Electrical Engineering plus six years of relevant experience or Master’s degree with four years of relevant experience as stated above. ********************************************************* https://jobs.smartbrief.com/action/listing?listingid=78EC80D2-E057-4F63-8611-8ECC7B1A626B&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Principal Systems Engineer IRIS International, Inc Job Description Description: IRIS International, Inc. is a leader in in vitro diagnostic urinalysis systems, digital imaging software development, sample collection, sample processing and small benchtop centrifuges and supplies for chemistry, coagulation, cytology, hematology, and urinalysis for the clinical

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and veterinary markets. The Company operates through its Iris Diagnostics division, and its Iris Sample Processing (formerly Statspin®) subsidiary. The Company's stock trades on the NASDAQ under the symbol "IRIS". We have a growth opportunity for a Principal Systems Engineer in our Chatsworth, CA corporate office. If you have the skills and experience described below - we are looking for you! IRIS International is a great place to work, has excellent benefits and will offer the right individual an incredible career opportunity. Job Summary: The successful candidate will participate in and lead the development of in vitro diagnostic (IVD) instruments that provide rapid and accurate diagnostic test results in clinical laboratories worldwide. Responsibilities/Duties: · Lead cross-functional engineering team · Define and develop System Architecture · Perform system modeling and analysis · Translate customer needs into engineering requirements · Decompose and allocate system level requirements into subsystem level requirements · Develop performance specifications · Develop system level control algorithms and timing · Perform Risk Analysis · Write verification and validation plans, protocols and reports · Perform and manage the execution of verification and validation testing · Transfer designs to manufacturing Required Experience: 10+ years experience with a life science company preferably in vitro diagnostics or medical devices. Any combination of patents, documentations, publications, methods improvement, instrumentation, and techniques totaling 10. Experience documenting and presenting written and oral reports including memos, technical reports, and presentations. Has made major contributions to the introduction of a new product or process resulting in significant cumulative increased sales, savings or value. Specific Skills/Knowledge: · Project management · Stage gate product development processes · FDA and ISO design controls · Logic timing diagram interpretation, mathematical and statistical analysis. Required Education: Advanced degree in Engineering or Physics ********************************************************* http://www.linkedin.com/jobs?viewJob=&jobId=4421497&trk=eml-anet_dig-b_premjb-ttl-cn&ut=2I-DADwODC05M1 Strategic Account Director (West) L&M Healthcare Communications- San Francisco Bay Area Job Description

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The Strategic Account Director (West) creates, maintains, and expands relationships with West Coast clients. Assigned current clients and prospective accounts, the Strategic Account Director has specific account objectives such as providing strategic leadership, supporting the successful execution of projects, programs, and initiatives, and achieving new and organic business growth. **Must have LifeSciences experience** Ideal candidate will have excellent, proven, skills in the following areas: new business development, medical education, project management, and client service. The Strategic Account Director (West) represents the entire range of L&M services to assigned clients, while leading the client account planning cycle and ensuring assigned clients needs and expectations are met by L&M. The Strategic Account Director (West) reports to the Chief Strategic Officer. Service

Establishes productive, professional relationships with key personnel in assigned accounts, keeping a finger on the “pulse” of the client

Enlists the involvement of L&M personnel, such as Project Management, Medical, and administrative resources, delivering on program/project objectives while meeting account performance goals and clients expectations

Strategy Acts as a trusted advisor on issues impacting the clients’ business Proactively assesses, clarifies, and validates client needs on an ongoing basis. Leads solution development efforts that best address client needs, while coordinating

the involvement of all necessary L&M personnel Sales

Identifies new business opportunities through traditional and innovative approaches Initiates joint L&M-strategic account planning process that develops mutual

performance objectives, financial targets, and critical milestones for a one and three-year period

Meets assigned targets for new/organic business growth and strategic objectives in assigned accounts

Desired Skills & Experience Must be located in CA (preferably in the SF Bay Area) Four-year college degree from an accredited institution MBA-preferred but not required Minimum ten years of experience combined from agency/medical education account

management, bio/pharma product management, consulting, and new business development

Must understand bio/pharma product marketing/ promotional medical education Oncology and CNS experience helpful This position requires extensive travel All prospective employees must pass a background check

Company Description L&M Healthcare Communications, is a KOL development, medical strategy & communications agency, located in Mountainside, NJ. L&M is composed of seasoned medical education agency executives, former bio-pharma manufacturer based marketers, and individuals with advanced degrees in medicine and the sciences. We are differentiated from other mid-sized agencies in that we have boutique divisions/services that address client needs through the product lifecycle. L&M Healthcare Communications Additional Information Posted:May 10, 2013 Type:Full-time Experience:Director Functions:Project Management, Business Development, Consulting

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Industries:Marketing and Advertising, Biotechnology, Pharmaceuticals Job ID:4421497 ******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5688402&trk=eml-anet_dig-b_premjb-ttl-cn&ut=0bVeCF9snA05M1 Posted by Angela Wang, Biometric Consultant, Real Staffing Senior Biostatistician Real Staffing - South San Francisco (San Francisco Bay Area) Job Description Works with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation,the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As part of a clinical assessment team, collaborates in the preparation and review of clinical assessments. For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Develops study analysis plans as a team member; lead this effort for selected studies. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, prepare data displays, and verify data accuracy and validity. Authors statistical analysis results in the clinical study report. With help from senior statistical staff, leads team members to author the report. Responsible for seeing the report through the review process. Supplies statistical input for BLA submissions and in response to FDA questions. Provides support for investigator publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc. Desired Skills & Experience Ph.D. in statistics/biostatistics with at least 1-2 years of clinical trials experience. Experience with statistical software packages such as SAS and S-Plus. Sound knowledge of theoretical and applied statistics. Sound understanding of regulatory guidelines in a pharmaceutical research setting. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy.

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With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted:May 10, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Job ID:5688402 *************************************************** Send an updated resume to brannon@alliedsearchpartners.com. We are currently hiring for multiple southern CA clients. CLS, CG, FISH, Flow Cytometry, CLS sub-specialties. Interested? For a complete and up to date list of ASP's Nationwide lab openings go to the attached link! Allied Search Partners, LLCalliedsearchpartners.com ************************************************************** Apply on company website Sr. Director Marketing - KI Franchise Onyx Pharmaceuticals - South San Franciso (San Francisco Bay Area) Job Description Sr. Director of Marketing for the KI Franchise is responsible for leading the KI Franchise US marketing team, with ultimate accountability for achieving or exceeding assigned sales goals and commercial margin. Essential/Primary Duties, Functions and Responsibilities:

Leads KI Franchise U.S. Marketing team Ensures team is motivated, and functioning and performing at or above expectation Accountable for highly successful industry leading performance of assigned brands Defines/establishes brands KPIs, and holds self and team accountable for achieving

goals Lead the development of co-promotion strategic plans in collaboration with Alliance

Partner. Assures that Onyx’s vision is reflected in the plan. Oversees development and execution of tactical plan Supports and provides input into lifecycle planning for KI franchise, LRP, and annual

planning cycle deliverables for the franchise Partners closely with sales management to ensure pull through and execution of brand

plan Drive to consensus with Alliance Partner on plan, budget and forecasts. Develop and implement strategic marketing plans. Align medical education and

promotional activities to achieve corporate objectives for products and services.

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Develop both short- and long-range strategies for assigned products Explore and evaluate new strategic concepts opening up new opportunities. Utilize and plan for needed market research that informs and influences product

strategy to meet changing market and competitive conditions. Ensures product communications are coordinated, support marketing plan objectives

and meet organizational expenditure requirements in conjunction with the leadership team

Understands and utilizes competitive intelligence Reports on function’s progress against corporate goals to senior management team. Establish and maintain productive working relationships with Onyx commercial partners

and with internal partners in global business analytics, global product strategy, medical affairs, clinical development and commercial finance.

Regularly interacts with KOLs to establish and cultivate relationships. Other duties as defined

Desired Skills & Experience Requirements Work Experience:

10+ years Industry experience 7+ years Marketing experience 5+ years Management experience 5+ years Oncology experience Sales experience Global Marketing/Lifecycle Management experience preferred

Management of Staff: Experience leading and developing teams including people managers will be required

Functional/Technical Knowledge & Skills: Motivational leadership style Strong business, commercial and clinical acumen Strategic thinking with the ability to formulate, develop and execute comprehensive

plans Strong influence & negotiating abilities Effective communication skills Excellent organizational and analytical skills Innovation and problem solving skills

Customer & Industry Knowledge: Demonstrates knowledge of disease states, Onyx products and competitive

environment Deep knowledge and understanding of markets where KI franchise products play a role Knowledge of pharmaceutical industry, relevant regulations and laws Knowledge of the business of oncology

Education/Training: Bachelors Degree required MBA or other Master’s degree strongly recommended Scientific background a plus

Other Requirements: Highly motivated, ability to be effective in a rapidly changing, small company

environment Competencies

Functional competencies in product strategy & commercialization Behavioral competencies in working with teams, collaboration in an unstructured,

rapidly growing environment Strategic agility and leadership Building and leading teams

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Market development Collaboration Innovation Results orientation/process excellence

Company Description Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a selective proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com. Additional Information Posted:May 6, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Pharmaceuticals Job ID:5627344 _________________________________________________________________ Senior Director, Sales - KI Franchise Onyx Pharmaceuticals - Corporate Office - South San Francisco (San Francisco Bay Area) Job Description The Senior Director Sales is responsible for optimizing the US performance of the Onyx KI Franchise products, Nexavar and Stivarga,meeting or exceeding corporate revenue targets. As part of the responsibilities the Senior Director is responsible for:

the development and execution of innovative and active field team coaching, development and engagement vehicles

the development and execution of comprehensive “best in class” training programs that deliver the practical, motivational, and developmental/training needs of the Onyx Sales Organization.

maintaining and operating a productive and successful collaborative working relationship with Bayer, our co-promotion partner on Nexavar and Stivarga, and other potential partners

partnering with the Senior Director Sales Proteasome Inhibitor Franchise to evolve and advance Onyx Sales Excellence

Essential/Primary Duties, Functions and Responsibilities: Responsible inspiring, leading, and motivating Onyx KI Franchise Sales Team

professionals Responsible for Onyx Sales Team performance and the achievement of Onyx

Pharmaceuticals sales targets In collaboration with US Brand team and other internal partners contribute actively to

strategy development, as well as the development and practice of innovative approaches to deliver exceptional Onyx performance

Develop a dynamic and innovative plan for future sales force evolution on effectiveness

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Work closely with cross-functional partners to ensure that policies, programs and processes are developed, implemented, communicated and consistently administered in compliance with organizational objectives and with relevant laws/regulations

Collaborate effectively with many partners, internal and external, to deliver optimal performance

Recommend the design and gain approval to implement an innovative and motivating Sales Force Incentive Plan that is aligned with Onyx objectives

Ensure “Best in Class-Industry” Sales Training capability and programs Participate in Working Group meetings with Bayer counterpart, demonstrating stong

contributions and collaboration Other Duties as assigned

Desired Skills & Experience 2+ years of Pharmaceutical/Biotech experience, 5 + years oncology experience 5+ years of Oncology Sales Management experience 4+ years of national sales/commercial leadership experience highly preferred Track record in managing multiple complex projects that have high organizational

impact. Demonstrated experience building high performance organizations and teams Broad base of commercial experiences across Oncology enterprise is desirable

Team Leadership and Development A proven inspirational and motivational Leader An enthusiastic appreciation of the fact that the ongoing development of others is

essential for Onyx to achieve its long term vision Identifies and creates opportunities that enrich the potential of others A collaborator that extends beyond one’s own team A values-based leader

Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):

Dynamic, self-starter with strong ability to influence. Strategic thinker with the ability to develop and implement effective sales tactics. Ability to develop and maintain strong professional relationships. Exceptional negotiation, facilitation and decision-making skills. Proven ability to visualize and implement change. Excellent organizational, problem-solving and management skills. Proven ability to develop talent, delegate and achieve results through others.

Customer & Industry Knowledge: Clinical Acumen- the ability to comprehend and effectively communicate complex

clinical data in a meaningful and impactful way. The ability to evolve data into messages

Oncology Business Acumen – demonstrated knowledge and successful experience in navigating the complex oncology business environment. Understanding circumstances and issues that can impede customers/patients access to Onyx products and services

Knowledge and agility in successfully overcoming payer-reimbursement challenges that may affect the oncology market and Onyx products

Education/Training: Requires Bachelor’s degree in sciences, business or marketing or equivalent

combination of relevant educational-professional experience. Master’s degree desirable Other Requirements:

Strategic thinker with the ability to innovate and be fully prepared for external market dynamics

Ability to maintain strong professional relationships across broad audiences Excellent organizational skills and acumen A problem solver, the ability to inspire a solutions orientation-expectation in others

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The ability to exhibit grace and maturity during times of stress Excellent oral and written presentation skills Ability to manage multiple projects with strong time management and organizational

skills Competencies Leadership Character –

Courage – the courage to experiment, to innovate, to challenge the status quo, to ask why, to tackle complex tasks and deliver thoughtful and thorough solutions, to participate in difficult conversations

Inspire – the ability to inspire others to perform and commit to incredible heights-goals. The ability to unite others in the inspiration of achieving-pursuing the mission of Onyx Pharmaceuticals

Leadership – the ability to lead an develop a group of individuals–team to a collective achievement that is greater than the sum of the individual accomplishments

Performance based, action oriented, solutions oriented, incredible perseverance Additional Information Posted:April 15, 2013 Type:Full-time Experience:Director Functions:Sales Industries:Pharmaceuticals Job ID:5402923 _______________________________________________________ Director, Sales Productivity and Effectiveness – PI Franchise Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description Position will be primary interface between Sales and cross-functional departments to ensure field force efficiencies are identified and achieved. Designs field strategy that will help to achieve sales performance, market access and marketing objectives. Success is measured on field execution and on initiatives focused on designing and interpreting business analytics, performance metrics or process improvement that drive increased commercial productivity and effectiveness. Essential/Primary Duties, Functions and Responsibilities:

Partner with Global Business Analytics to design high-impact business reporting and analytics. Responsible to ensure field sales fully understands business utilization and impact of business planning tool set.

Lead initiatives and analyses that identify business opportunities for the field leadership teams to positively impact sales growth.

Interface with field sales, market access, global business analytics, and marketing to review, analyze, and evaluate field promotional efforts.

Effectively manages expense/budget process and dissemination to team Effectively communicates the strategic and tactical elements of marketing plans by

leading metric identification and measurements to field sales management Provides leadership to assure effective teamwork and transparency between field and

marketing functions is maximized. Identifies, develops,implements, and communicates best practices focused on field

force execution of the marketing plan. Harmonize the core requirements of franchise:

o Provide ongoing communication and initial training to the Field Sales force on all aspects of call planning, alignments and targeting. o Drive and assist in the developing business plans, including templates and tools to assist with cross functional business reviews.

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o Act as team lead for incentive compensation development, deployment, and measurement (including budgeting) to ensure positive motivational impact on field sales team o Oversee the execution of all aspects of sales meetings relating to design, agenda core objectives, and execution. Works closely with all stakeholders, and with Training, TROPIC, and MarComm in meeting sales force needs for meetings

Serve as an active member of cross-functional committees/Field Force Effectiveness teams to execute promotional plans, strategic projects and initiatives.

Manage the application and communication of all Onyx policies, procedures. Designs training solutions to ensure Onyx and its employees remains compliant with internal and external policy and regulation.

Manage long-term projects that require constant follow-up and detail focused on improving sales organization productivity and effectiveness

Perform ad-hoc analyses and special projects, for Sales Management. Other Duties as assigned

Desired Skills & Experience Work Experience:

7+ years sales, sales training, sales management, marketing, sales operations or other commercial experience

Relevant disease oncology and disease state experience strongly preferred Cross-functional and home office experience highly desirable. A clear track record of leading dramatic growth through successful sales and marketing

strategies and execution for a company selling technology-related products/services directly to businesses.

Proven ability to work closely with internal commercial teams from remote, home-based location.

Management of Staff: N/A Functional/Technical Knowledge & Skills:

Dynamic, self-starter with strong ability to influence. Strategic thinker with the ability to develop and implement effective sales tactics. Ability to develop and maintain strong, professional relationships. Strong proficiency with Microsoft Word, Excel, PowerPoint. Microsoft Access a plus. Exceptional negotiation, facilitation and decision-making skills. Proven ability to visualize and implement change. Excellent organizational, problem-solving and management skills. The ability to work effectively in a team based environment, with internal and external

stakeholders. Customer & Industry Knowledge:

Relevant disease oncology and disease state experience strongly preferred Education/Training:

Requires Bachelor’s degree in sciences, business or marketing or equivalent combination of relevant educational professional experience. Master’s degree desirable.

Other Requirements: Ability to comprehend and skillfully navigate scientific subject matter Exceptional verbal and written communication skills

Additional Information Posted:April 15, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales Industries:Pharmaceuticals Job ID:5402917 ___________________________________________________________

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Sr. Manager/Associate Director, Product Strategy - PI Franchise Onyx Pharmaceuticals - South San Francisco (San Francisco Bay Area) Job Description The Senior Manager / Associate Director of Product Strategy (physician promotions) will develop and implement programs and initiatives in support of Kyprolis in multiple myeloma. Essential/Primary Duties, Functions and Responsibilities:

Works effectively with sales force, sales management, TROPIC committee, and various other brand and internal cross functional team leaders in order to successfully develop and execute marketing programs to multiple myeloma treaters (hematologists/oncologists).

Assist in developing short and long-range strategies. Provides input into the Brand Plan. Develop promotional tools including brochures, slide kits, advertisements, and digital

content to convey messages. Develop and deliver presentations as needed to commercial management and other

internal groups. Assists in managing the relationship with the advertising agency of record and multiple

other vendors. Partners with the Kyprolis Field Advisors for Strategy and Training (KFAST) team and

Sales Training to optimize the development and utilization of promotional pieces. Ensure product compliance with US regulatory. Develop and assist in managing the promotions budget. Other Duties as assigned.

Desired Skills & Experience Work Experience:

6-8 years work experience in product marketing, field sales, sales training, market planning, or management consulting in the pharmaceutical/biotech industry, with 1 year previous brand marketing experience required.

1+ year oncology experience preferred Functional/Technical Knowledge & Skills:

Ability to use marketing skills to optimize Kyprolis in a competitive market Strong influence skills; ability to change the thinking of or gain acceptance of others in

sensitive situations Good presentation skills with the capacity to conduct presentations of technical

information concerning specific projects/skills Commercial, Regulatory and technical awareness Strong leadership skills Experience fielding primary marketing research is a plus Excellent organizational, analytical and problem solving skills Capable of exercising judgment within broadly defined practices and policies in selecting

methods, techniques and criteria for obtaining results Oncology knowledge

Education/Training: Requires Bachelors/Master degree and relevant educational and professional experience Strong scientific background

Other Requirements: Excellent written and verbal communication

Additional Information Posted:April 25, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals

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Job ID:5528298 ******************************************************************* Apply on company website Sr. Corporate Paralegal Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description What we are looking for? Candidates who have experience with:

Corporate governance (board meetings, board minutes, annual meetings) Section 16 filings and Subsidiary maintenance

Brief Description The Senior Paralegal shall provide professional legal support services to the Law Department in the form of drafting and negotiation of contracts, documents and memoranda for the attorney’s review, in addition with assisting with legal training within the company. This individual is primarily responsible for the review and negotiation of high volume of contracts that are received daily by the Law Department. Description Contracts:

Responsible for review, negotiation and management of primarily commercial contracts, including, but not limited to, master service agreements, managed care agreements, distributor agreements, rebate agreements, independent contractor agreements, including agreements with healthcare professional, vendor service agreements, statements of work and nondisclosure agreements.

Draft and assist with the management of company contract templates, including creating and updating templates according to new company guidelines, laws or legal requirements.

Assist with managing contract workflow and online contract request system for internal client use.

Coordinate and conduct trainings for contract workflow system to Contract Liaisons. Interact with Compliance and Regulatory to help ensure legal compliance with

contracts. General Legal:

Train legal administrative staff on legal processes, laws and terminology. Assist with drafting, coordinating and conducting law department trainings to internal

clients on contract processes and procedures. Partner with Human Resources, Compliance and Finance on improving and

implementing processes to mitigate liability and provide efficiencies within the department and company.

Performs legal research on an “as needed basis.” Design, recommend and implement new processes and procedures to increase group

efficiency and productivity. Using business and contract negotiation knowledge, identify issues, develop and

analyze alternative solutions, make recommendations and implement. Engage in due diligence and other activities relating to corporate development projects. Function as a point of contact to resolve legal and business issues. Lead or participate in various legal projects and collaborate on cross-functional

initiatives. Desired Skills & Experience Other Responsibilities:

Provide support for maintaining and filing corporate business filings—annual reporting, foreign filings

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As needed, assist with litigation matters, including document collection for discovery process and coordinating with outside counsel for appropriate retention of attorney client privileged documents and work product.

Education/Training:

Bachelor’s degree, technical certificate or equivalent. Paralegal certificate preferred. Minimum of six (6) to ten (10) years of substantive contracts drafting, review and

negotiation experience. Biotech contract experience required.

Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Legal Industries:Pharmaceuticals Job ID:5625748 ________________________________________________________________ Drug Safety System Administrator Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description Description With minimal guidance, the Drug Safety System Administrator will provide administration of the pharmacovigilance and drug safety system ARISg, and affiliated systems and modules; participate in system enhancements and upgrades; oversee and actively participate in GxP validation efforts; and work closely with the business by partnering with the Drug Safety Systems and Information Management team. The Administrator works with the IT system validation team to ensure that the application remains in a validated state, complying with regulations such as 21 CFR Part 11 and ANNEX 11. The Administrator serves as the primary contact between the organization and external partners providing technical implementation, training and system support services. Essential/Primary Duties, Functions and Responsibilities: Provide operation and maintenance support for Onyx’s drug safety system, currently Aris Global’s ARISg system, and any affiliated tools and modules (e.g., IRT, ESM)

Handle technical support requests for development, QA and production environments Track all system issues from initial report to successful resolution and perform annual

review of support tickets Partner with external vendor(s) providing project implementation or operational support In partnership with the systems validation groups, ensure application and systems

remain in a validated state including writing and executing change controls with risk assessments, performing periodic system reviews per standard operating procedures, and updating validation deliverables

Monitor and maintain system stability including staying abreast of patches Assist in code promotion and software upgrades utilizing established change control

procedures Serve as the technical lead on project teams for system implementations, upgrades and

enhancements for the drug safety and related systems Participate in structured and documented post-change system testing, enhancing tests

as needed when new functionality is added Support and maintain customizations and integration points that move data in and out

of the drug safety system and other related systems and databases

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Coordinate, optimize and monitor backups for software, servers, databases, and appropriate log files

Oversee user and group administration in Microsoft Active Directory Perform annual restore testing of entire system Create and maintain application and other IT documentation, manuals and procedures Develop in-house knowledge repository for issue resolutions Determine and present new technical solutions for improving processes by collaborating

with end-users of various levels (from tactical to management) throughout the company.

Other duties as assigned. Desired Skills & Experience Work Experience:

Minimum of five years of industry experience administering a Global Drug Safety & Pharmacovigilance Database: preferably ARISg Safety Suite. We will accept similar experience ARGUS Safety suite experience.

Experience in deployment, debugging and troubleshooting a safety solution along with product configuration required

Functional/Technical Knowledge & Skills: Knowledge and experience of the following ARISg modules is desired:

o ARISg o agXchange IRT/OST/ESM o agConnect o agSignals o Synchrony EDI Gateway

Experience with drug safety dictionaries (e.g. MedDRA, WHO Drug Dictionary) Back-up and recovery experience and experience in SQL Scripting (Oracle) required Knowledge of report development in Business Objects a plus Experience with Citrix and terminal server implementations a plus Experience with supporting Oracle WebLogic Application Server a plus

Customer & Industry Knowledge: Knowledge of global regulatory requirements for worldwide pharmacovigilance desired Knowledge of Drug Safety business processes, GxP guidelines, 21 CFR Part 11

compliance, Computer System Validation and Release management cycle Ability to build strong relationships with drug safety system vendor support and third-

party vendors Education/Training:

University degree in Computer Science or relevant work experience Other Requirements:

Outstanding communication skills (verbal and written). Strong analytical and assessment skills Strong judgment and problem solving skills. Outstanding interpersonal skills and professionalism Ability to work independently, as well as within a cross-functional team environment Ability to work in a dynamic environment and manage competing priorities

Competencies

Problem Solving – Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; looks beyond the obvious and doesn’t stop at the first answers

Communicates Effectively – Appropriately shares information in a timely manner that impacts others; communicates with respect, clarity, transparency and honesty and coaches others to do the same.

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Centers on Customers – Recognizes the range of customers including key stakeholders and demonstrates strong understanding of their needs and requirements; strives to be best in meeting customer and stakeholder needs and serves as their voice across Onyx.

Additional Information Posted:April 30, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Pharmaceuticals Job ID:5568854 ______________________________________________________________ Senior Health Outcomes Research Liaison - REMOTE Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description Senior Health Outcomes Research Liaison - REMOTE South San Francisco, CA Full Time/Direct Hire Brief Description Will be responsible for integrating scientific expertise and knowledge with brand strategies to ensure successful implementation of the Company's marketed and emerging product portfolio. This will be fulfilled primarily through the development of excellent collaborative relationships with opinion leaders and influencers in the specialties of health outcomes, pharmacoeconomics, and value proposition analysis. Description Will be responsible for integrating scientific expertise and knowledge with brand strategies to ensure successful implementation of the Company's marketed and emerging product portfolio. This will be fulfilled primarily through the development of excellent collaborative relationships with opinion leaders and influencers in the specialties of health outcomes, pharmacoeconomics, and value proposition analysis. Essential/Primary Duties, Functions and Responsibilities:

Identify key national and regional HEOR thought leaders and priority customers, build and maintain advocacy with these individuals, and function as their primary scientific contact with Onyx.

Participate in the collection and exchange of HEOR information important to Onyx development effort.

Management of relationships between HEOR key opinion leaders and Onyx Medical and Scientific Affairs.

Collaborate with external investigators and Onyx functional partners on the development of outcomes research studies

Help develop and deliver HEOR communications with the goal of providing evidence based, credible, and consistent information to the reimbursement, value, and access community

Within regulations and guidelines, disseminate data in support of HEOR efforts Assist in the development of, and participate in, regional advisory boards and medical

education programs Represent Onyx MedSA at relevant meetings and conferences Maintain clinical and technical expertise in the area of oncology through review of the

scientific literature and attendance at key scientific meetings Serve as a role model to team members Lead projects as assigned

Desired Skills & Experience Work Experience:

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4+ years’ experience as a medical affairs field representative (MSL + HOL), with 2+ years as a HOL.

Prior experience as an MSL or HOL in the field of oncology preferred. Patient care clinical experience in the therapeutic area (including sub-specialty)

preferred Management of Staff:

Not applicable Leadership experience (with direct reports or as an individual contributor) is a

preferable trait Functional/Technical Knowledge & Skills:

Ability to efficiently manage time and priorities. Strong leadership skills and the ability to compile and disseminate information to others

in a cohesive fashion to assure a clear understanding of project status and direction. Customer & Industry Knowledge:

Solid understanding of drug development and life-cycle development of a product. Ability to cultivate and maintain relationships with thought leaders and to establish trust

through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders

Education/Training: Graduate-level scientific degree required; doctorate strongly preferred (Pharm.D., P.A.,

or Ph.D.) Preference given to applicants with specialty training in HEOR

Other Requirements: Excellent communicator, skilled at diplomacy and capable of effectively combining

science and relationship building. Willingness to travel extensively.

Competencies Planning (organizing, priority setting, time management) Action Oriented Ethics and Values Customer Focus Communications (written, verbal) Presentation Skills

Additional Information Posted:April 25, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science Industries:Pharmaceuticals Job ID:5530116 ___________________________________________________________________ Network Engineer Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description Network Engineer Full Time/Direct Hire South San Francisco, CA Brief Description This position is a member of the Infrastructure Services team responsible for a growing number of network services within Onyx’s IT environment. Its primary focus is to maintain IT infrastructure the stability, scalability, and performance so that IT operations conform to SLAs

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and growing business needs are achieved. The role will also assist in solving escalated tickets from the Helpdesk team and serves as level II support within the Infrastructure Services team. Description

Working as part of a team to ensure the stability, scalability, performance of Onyx’s IT network environment which include networks, telecommunication, IDS, firewalls, radius, sftp, log management, monitoring, security, and change management.

Troubleshoot complex IT infrastructure problems. Work independently on task assignments and collaborate effectively with other team

members to achieve project deliverables. Participate in development of processes, procedures, and controls in Onyx’s IT network

environment. Maintain up-to-date documentation on existing Onyx’s IT network environment. Follow design guidelines from senior team members and implement solutions in a

dynamic fast paced IT environment. Partner with the Helpdesk team by providing escalation support and technical expertise. Participate proactively to ensure that Onyx’s IT network environment is performing

optimally. Apply best practices on Onyx’s IT network environment and related processes. Adhere to Onyx’s Sarbanes-Oxley and FDA compliance controls. Communicate effectively when providing instructions on the use of IT infrastructure

services or when providing assistance in resolving technical problems. Collaborate with other IT groups to review requirements for all network changes. Work with MSP to implement telecommunication changes. Perform and maintain cable management in IDF and server room. Review and address IDS notifications Review and recommend all aspects of network and security monitoring criteria. Perform firmware and patch deployment activities according to IT guideline and

processes. Perform network backup according to Onyx’s Backup SOP. Manage all network aspect of Onyx’s disaster recovery and business continuity solution. Assist third party vendors to achieve successful SOW deliverables Increase skill sets through various means of delivery. (e.g. meetings, on-line/classroom

trainings, seminars, and in-service training sessions.) Work Experience:

5 - 8 years of professional, related work experience as a Network Administrator/Engineer in 800+ users environment.

Experience supporting IT infrastructure at a midsize global company. Experience engaging IT projects with third party vendors. Some IT operations exposure in a FDA and/or SOX regulated setting. Experience supporting a unified communication environment.

Desired Skills & Experience Functional/Technical Knowledge & Skills:

Proficient with Visio and Microsoft Projects Demonstrated excellent documentation skill Exposure in the following areas:

o Active Directory and Microsoft Windows 2008/2012 Server technologies. o Expose to ITIL processes. o VMware vSphere 4.1 or above virtualization

Demonstrated hands on experience with the following technologies: o Log management & network monitoring software (e.g. Splunk, Solarwinds) o Unified communication (e.g. Call Manager, Lync) o Cisco ASA, ISR, and Catalyst o VPN solutions (e.g. AnyConnect, DirectAccess)

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o Cisco WAP or related wireless technologies. o Storage protocols (e.g. NFS, iSCSI, CIFS) o Network protocols (e.g. EIGRP, OSPF, DNS, DHCP, SMTP, and TCP/IP

Education/Training: Bachelor’s degree in Computer Science or related degree, or equivalent combination of

education and work experience. Must have CCNA/CCDA or equivalent knowledge. CCNP/CCDP, MCITP, or VCP a plus. Ability to work independently and collaborate effectively in a team environment. Must be organized and be able to handle rapidly changing priorities. Excellent written and verbal communication skills. Must have strong documentation skills on IT processes, systems, and procedures. Must have strong interpersonal skills. Willingness to work flexible hours (including off-hours) and participate in an on-call

rotation as required. Exhibit creativity, flexibility, critical thinking, professionalism, reliability, and a *can do*

attitude is key. Comfortable working under tight timelines.

Additional Information Posted:April 24, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Pharmaceuticals Job ID:5515580 _________________________________________________________________ Director, State Government Affairs (REMOTE - Sacramento/San Francisco) Onyx Pharmaceuticals- Sacramento (San Francisco Bay Area) Job Description Onyx is looking for a Director, State Government Affairs (this is a remote position in West Coast) to come in and handle the state government affairs for the west coast. Headquartered in South San Francisco, CA, Onyx received FDA approval for two drugs in 2012. Our sales teams are now promoting 3 oncology drugs in 5 indications and as a result, Onyx is in explosive growth mode! In 2012, we hired 300+ new employees and we are poised to hire another 250+ in 2013. Onyx has received awards for our overall performance as a company, our contributions to the community and our patient advocacy. We have made the top 20 list in the MedAdNews 21st Annual Top 100 Biotechnology Companies List in June 2012 and we were awarded the Outstanding Product Award for Kyprolis™ (carfilzomib)for Injection at the Northern California BayBio Pantheon Awards in November 2012. What we are looking for?

Biotech experience in Government Affairs role Legislation and industry experience preferably in oncology (as we are an oncology

focused company) Travel: Yes (Extensive travel to Sacramento – Since it’s a state regulatory affairs

position for West Coast) PLEASE NOTE: This is a "West Coast Remote-based" position not entirely Remote. Candidates should be open to relocating to Sacramento or Bay Area.

Here is the job description for your reference: Director, State Government Affairs (REMOTE - West Coast) South San Francisco, CA Direct Hire/Full Time

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Brief Description The Director of State Government Affairs will provide expertise in government affairs by translating state political and policy issues into strategic and actionable plans. Primary responsibilities include leading local and state government affairs strategy in South San Francisco and across the top priority states including California and Texas while monitoring 15 western states to optimize and champion market access to facilitate market entry in new and emerging markets. Additionally, evaluating Description The Director of State Government Affairs will provide expertise in government affairs by translating state political and policy issues into strategic and actionable plans. Primary responsibilities include leading local and state government affairs strategy in South San Francisco and across the top priority states including California and Texas while monitoring 15 western states to optimize and champion market access to facilitate market entry in new and emerging markets. Additionally, evaluating and assessing access to cancer treatments for Onyx therapies through State Exchanges in the western states are a key function of this role. In this role the Director will advance sound public health and legislative policies in areas of importance to Onyx at the local and state level with a particular emphasis on policies to address oncology policies specific to multiple myeloma, liver cancer, advanced renal cell cancers, colorectal cancer and GIST. The Director will oversee and manage professional lobbyists in multiple states. They will develop trusted relationships with elected officials and their staff, utilize expertise and knowledge internally and externally to develop and craft policy positions and collaborate with third-party stakeholders that impact policy decisions and drive change. This position will be covering the west coast. Essential/Primary Duties, Functions and Responsibilities:

Responsible for state government affairs/government relations and engagement across the western region of the country with attention to local government and stakeholders in South San Francisco, CA on key policy issues while working with a contract lobbyist to monitoring healthcare legislation in the remaining states.

Responsible for understanding and communicating how state exchanges will provide access to cancer treatments through communication with state Insurance Commissioners and State Health Exchanges while working with state legislature and contract lobbyist to elevate awareness on the issue and identify appropriate state level contacts to assess the issue.

Responsible for working with state Medicaid programs to ensure access for Onyx products.

Responsible for identifying state legislative, executive branch, and regulatory proposals and policies impacting the marketing and selling of Onyx Pharmaceuticals products, analyzing the impact of those proposals on ONYX, and developing policy recommendations to address those proposals.

The State Government Affairs Director develops and implements appropriate strategies and tactics to achieve the desired outcomes through a combination of direct lobbying and legislative coalition-building.

Major program responsibilities include negotiating rebates with state Medicaid agencies, the legislative and budgetary facets of Medicaid, and state pharmaceutical assistance initiatives for the elderly.

State Government Affairs Director responsibilities includes working cross-functionally with ONYX’s policy staff and business operations to assure effective “pull through” for products in the region. Through political skills and policy knowledge, the State Government Affairs Director is able to make decisions on legislative/regulatory matters.

State Government Affairs Director has an established broad range of contacts, an in-depth knowledge of processes, policy expertise and extensive issue management skills.

The State Government Affairs Director, SGA must have an understanding of issues effecting not only the sale and marketing of prescription medicines, but also of issues facing a large, national business operating in the United States. Those issues include,

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but are not limited to, tort and related civil justice reforms, tax, worker’s compensation and environmental policies, and economic development.

The State Government Affairs Director identifies and facilitates introduction of ONYX Executives to targeted state legislative and executive branch leadership and prepares ONYX Executive briefings for meetings with leadership which advance ONYX strategic objectives. As well coordinating quarterly government speaker series onsite at Onyx Pharmaceuticals in South San Francisco, CA

The State Government Affairs Director must demonstrate an intuitive sense of issues affecting the ONYX corporate image and exercises the necessary judgment to protect and advance the image in all oral and written communications and interactions with state government officials and business community thought leaders.

The State Government Affairs Director will successfully integrate him/herself into policy and business organizations that can advance ONYX legislative and policy objectives and actively works to educate, advocate for, and protect ONYX strategic interests.

Responsibilities also include protecting both patients’ and the company’s interests by working through and within state government policy, laws and regulations, to ensure the greatest possible access for Onyx products to key patient populations.

Assess outside counsel and lobbying needs within each state and manage these resources appropriately.

Responsible for devising strategic policy initiatives designed to ease or open access to patients for Onyx products. This includes evaluating the need for outside counsel and lobbying services.

Desired Skills & Experience Work Experience:

Experience with understanding bio pharmaceutical industry trends with a strong knowledge of, and experience with, US State Government Agencies

Experience in translating political activity and policy trends into commercial impact Success with political engagement to support market access and reimbursement Experience with the legislative processes Proven track record of successful advocacy and winning legislative battles and current

relationships with elected officials, agency heads and policymakers. Management of Staff: None Functional/Technical Knowledge & Skills: Proficient use of technology including MS Office Software Package and Internet resources is expected. Customer & Industry Knowledge: Relationships with state and local government officials in Sacramento and South San Francisco, CA, and some priority states are desirable. Additional relationships with CA industry associations and Key stakeholders are also highly desirable. Education/Training:

Bachelor's degree in political science, business or life sciences preferred. Minimum of 7 years of experience in related experience in State Government Affairs,

ideally in oncology both new market and established market. Prior experience with federal/state affairs is preferred. A diverse background to include

but not be limited to: Field Management, Corporate Account, Marketing, Reimbursement, or Managed Care experiences are a plus.

Other Requirements: Competencies

Excellent interpersonal, analytical, and communication skills, both written and oral are necessary.

Strong organizational, planning, conceptual, and strategic thinking skills Must be able to work successfully within a team/partnership environment and as an

individual contributor, with a high level of professionalism

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Demonstrated ability to lead and provide guidance to others Ability to build and maintain deep relationships with both internal and external

stakeholders, executives and thought leaders Candidate must be an adaptive, innovative, strategic thinker, self-starter and

demonstrated team player with strong leadership abilities actively demonstrated in prior positions

Additional Information Posted:April 23, 2013 Type:Full-time Experience:Director Functions:Other Industries:Pharmaceuticals Job ID:5501129 ___________________________________________________________________ Sr. Manager US Kyprolis Marketing Onyx Pharmaceuticals- San Francisco Bay Area Job Description Senior Manager, US Kyprolis Marketing South San Francisco, CA Full Time/Direct Hire Our Kyprolis Marketing group needs a new leader. The person must be driven, yet empathetic. A developer of people who knows how to get the most of our group of superstars and up-and-comers. Is it time for a change? If you’re ready to push yourself and your career to new levels you should consider Onyx Pharmaceuticals where our mission is developing new therapeutics for treating cancer. Our marketing team works on exciting critical projects and as part of this we now have an opening for a Sr. Manager, US Kyprolis Marketing. If you have a background in oncology and marketing and would like to make an impact in patients lives check out the details and apply now. If this job doesn’t sound perfect for you, join our Onyx Pharmaceuticals talent community. Here you’ll have a chance to explore other career opportunities. The position will serve as the lead for KyprolisTM(carfilzomib) US Commercial KOL engagement planning. Job responsibilities include the development of engagement plans, Advisory boards planning, and speaker bureau coordination. Essential/Primary Duties, Functions and Responsibilities:

Coordinate with Medical Affairs, Field marketing and HCP Network Activities on the development of KOL plans for Multiple Myeloma. Regularly interacts and develops relationships with Myeloma KOLs.

Work with Field marketing and sales operations to manage peer to peer engagements through the speakers’ bureau.

Partner with promotions and field marketing on the development of materials and resources for the speakers’ bureau.

Develop and implement the Kyprolis community advisory board plan. Collaborates effectively with Kyprolis sales force, sales management, Legal Medical

Regulatory Reviews committee, and various other brand and internal cross functional team leaders in order to successfully develop and execute marketing programs.

Partners with Field marketing and Network leads to develop the peer-to-peer activities plan

Develop and deliver presentations as needed to commercial management and other internal groups.

Assists in managing relationships with multiple vendors and outside consultants. Partners with Sales training to optimize learning opportunities for the field. Assist in developing short and long-range strategies. Provides input into the Brand Plan.

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Develop and assist in managing the peer to peer and network activities budget. Ensure product compliance with US regulatory requirements. Other Duties as assigned.

Desired Skills & Experience Work Experience:

5-8 years work experience in product marketing, field sales, sales training, market planning, medical education or management consulting in the pharmaceutical/biotech industry, with 1 year previous brand marketing experience required.

1+ year oncology experience preferred. Management of Staff: Not at hire Functional/Technical Knowledge & Skills:

Ability to use marketing skills to optimize Kyprolis positioning in a competitive market. Strong influence skills; ability to change the thinking of or gain acceptance of others in

sensitive situations Good presentation skills with the capacity to conduct presentations of technical

information concerning specific projects/skills. Commercial, Regulatory and technical awareness Strong leadership skills Experience fielding primary marketing research, moderating is a plus Excellent organizational, analytical and problem solving skill Capable of exercising judgment within broadly defined practices and policies in selecting

methods, techniques and criteria for obtaining results Oncology knowledge

Customer & Industry Knowledge: Oncology/ Hematology experience preferred

Education/Training: Requires Bachelors and relevant educational and professional experience Masters degree preferred

Other Requirements: Excellent written and verbal communication Ability to work with others

Additional Information Posted:April 23, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals Job ID:5501127 ________________________________________________________________ Associate Director OR Director, Enterprise Program Management Onyx Pharmaceuticals - South San Francisco (San Francisco Bay Area) Job Description Do you want to work for a fast growing company with an executive team that is recognized as leaders in the biotechnology industry? Do you have the passion and drive to excel in what you do? Then look no further! Onyx is looking for an Associate Director OR Director, Enterprise Program Management responsible for various kinds of interesting projects! This person would be handling process-focused responsibilities. Headquartered in South San Francisco, CA,Onyx received FDA approval for two drugs in 2012. Our sales teams are now promoting 3 oncology drugs in 5 indications and as a result, Onyx is

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in explosive growth mode! In 2012, we hired 300+ new employees and we are poised to hire another 250+ in 2013. Onyx has received awards for our overall performance as a company, our contributions to the community and our patient advocacy. We have made the top 20 list in the MedAdNews 21st Annual Top 100 Biotechnology Companies List in June 2012 and we were awarded the Outstanding Product Award for Kyprolis™ (carfilzomib)for Injection at the Northern California BayBio Pantheon Awards in November 2012. WHY WE ARE LOOKING?

This position is open due to heavy growth within the organization! The position could be at an Associate Director level or Director level - depending upon

your experience. So, are you a Sr. Manager/Manager then Associate Director is to go! Are you at a Director-level? Then Director is to go!

WHAT WE ARE LOOKING FOR? Process-focused experience Strong process-improvement and documentation experience (in a biotech/pharma

setting a huge plus!) Experience supporting different areas within the organization Broad range of experience, especially consulting experience handling biotech/pharma

clients would be a huge plus! A combination of Project Manager + Process Leader - be able to engage in the project.

More like a Process SME SOUNDS LIKE YOU? Then go ahead and apply! Here is the traditional summaryof the position aka the job description :-) The Director, EPMO will develop and maintain enterprise wide business process maps and identify Business Process Owners. Leveraging this strategic process viewpoint the Director will engage leaders throughout Onyx to understand areas for process improvement. By conducting interviews and facilitating meeting with business partners the Director will apply BPI methodologies to derive and validate business processes models that define as-is and to-be process flows and build consensus on a plan for process improvement. Essential/Primary Duties, Functions and Responsibilities:

Investigate and learn business issues and data challenges of the business through daily interaction with the department members and their leadership.

Develop and maintain current state process documentation. Build desired future state process documentation. Create awareness of process improvement opportunities by doing internal stakeholder

analysis; competitive market scans; industry best-practice analysis; and strength, weakness, opportunity and threat analysis.

Build consensus among a diverse group of process stakeholders in order to facilitate a resolution to the challenges that arise from business processes that span many functional, divisional and geographic areas of a company.

Identify process "pain points" or disconnections and translate them into process improvement opportunities, such as cost savings/avoidance, productivity gains, quality improvements or revenue generation. Recommend the correct process improvement approach to process stakeholders to achieve business outcomes.

Identify current state baseline metrics and create target performance metrics for future state process.

Develop metrics and measurements of new process initiatives. Define the post-implementation strategy for continuous process improvement. Provide domain knowledge and insight to shape "to-be" processes for particular process

areas or vertical-industry subsections. Understand how systems are affected by business process change. Provide advice and oversight of process change initiatives.

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Establish the principles, directions and standards as it relates to the business process solution framework for Onyx.

Mentor colleagues in process improvement techniques. Responsible for ensuring that Onyx methodologies are applied in process design. Other duties as assigned.

Desired Skills & Experience Work Experience:

12+ years BioPharma experience in increasing levels of responsibility Experience working in a variety of business functions Proven track record of building consensus and forming coalitions Experience with change management and adoption methods Experience facilitating process improvement workshops and building consensus on a

plan for continuous process improvement Experience managing cross-functional process improvement efforts Ability to develop and deliver project specific training material and coursework

Management of Staff: The Business Process Architect will hire and lead a small team of Process Consultants

Customer & Industry Knowledge: Experience in Biotech or Pharmaceutical industry working on cross functional projects or

within multiple business domains (e.g. Commercial, R&D etc) Education/Training:

Bachelor of Science degree (in science, engineering or business), with related business discipline experience.

MBA or master’s degree in a relevant field preferred. Other Requirements:

Excellent verbal and written communication required. Proven ability to work with diverse project teams on successful projects

Competencies Challenges the Status Quo Leads and Embraces Change Communicates Effectively

Additional Information Posted:April 23, 2013 Type:ull-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals Job ID:5501124 ____________________________________________________________________ Director, Solutions Delivery (Data Warehouse/Pharma) Onyx Pharmaceuticals - San Francisco Bay Area Job Description Director, Solutions Delivery South San Francisco, CA Full Time/Direct Hire Here is what we are looking for:

The Solutions Delivery group we will have an opinion on architecture and technology. Data Warehouse experience is what we are looking for Extensive experience with clinical technology hence biotech/pharma experience is highly

desired! Looking for someone who has designed a Data Warehouse Solutions Delivery experience as in, experience delivering solutions as compared to

managing projects

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Summary The Director of IT Solutions Delivery manages the Solutions Team, comprised of the IT Project Management function, technology architects, database managers/architects and key technology developers. This position utilizes the Solutions Team to deliver all IT-based business solutions, driving business performance improvements and assuring scalable business processes. The Solutions Delivery leader drives target technology architecture, data management/data warehouse capabilities, strategic technology roadmaps and project management standards. The Solutions Delivery leader also advises on technology advancements and applicability of new technologies to Onyx, advocating for technology investments as appropriate. The Director of IT Solutions Delivery and team will work collaboratively with the Applications Support team and the Infrastructure and Operations team to ensure developed solutions are consistent with our existing technologies or on the targeted roadmap. Primary Duties, Functions and Responsibilities

In close connection with business teams and IT Business Partners, deliver key business capabilities and process improvements

Provide direction on interrelated projects throughout the project lifecycle Develop a target technology architecture that allows for strategic technology platform

investments. Assure that the technology architecture is endorsed by IT leadership and key business stakeholders

In partnership with IT leadership and key business stakeholders, develop technology roadmap that indicates current state of technology solution and timeframe for future investments

Define high-level migration plans to address the gaps between the current and future state (connected to technology roadmap/architecture), typically in sync with the IT budgeting or other capital planning processes

Assure that the Solutions Delivery team stays focused on corporate goals and delivers against architecture requirements and strategic direction

Deliver high-level project status reports and key portfolio metrics Review all projects proposals prior to IT Steering Committee consideration to assure

adherence to standards and alignment with strategic plan Partner with Infrastructure team on back-end improvements for key enterprise

technologies such as Identity and Authentication Management, and mobility solutions. Partner closely with Applications Support/Compliance team to deliver high-quality

solutions that require minimal support and problem resolutions post launch and that adhere to all U.S. and international regulations (SOX, CFR part 11, Annex 11, HIPAA, Directive 95/46/EC, etc.)

As required, provide high level support for all technology solutions to assure critical issues are resolved in a timely manner. Participate in Root Cause Analysis and help develop resolutions.

In partnership with IT Leadership, develop procurement/vendor strategies that provide high-quality vendor partnerships at the lowest possible cost

Manage budgets and delivery deadlines accurately Oversee and facilitate the research, evaluation, selection and documentation of

hardware and software technology and product standards, as well as the design of standard configurations.

Identify the organizational impact (for example, on skills, processes, structures and culture) and financial impact of proposed target technology architecture

Consistently assess direction of technology while being vigilant and proactive with budget and regulatory needs

Desired Skills & Experience Requirements Work Experience:

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15+ years of IT or business/industry-specific work experience with a minimum of 5 years in a leadership position.· 8+ years of experience in application management, project management, solution delivery, solution/enterprise architecture, data management and systems analysis Management of Staff:

Lead a team responsible for several major IT functions including project management, technology architecture, data management, technical solution development.

Responsible for all aspects of the development of direct reports including performance management, goals, and individual development plans,

Functional/Technical Knowledge & Skills: Ability to quickly understand business models and supporting technologies Deep understanding of information systems, business processes, the key drivers and

measures of success for the relevant business Must have the ability to work effectively with the technical team to resolve technical

issues and provide solutions to complex business requirements. Able to interpret business-level requirements and interact with business customers Excellent interpersonal skills in areas such as teamwork, facilitation and negotiation Strong leadership skills Excellent analytical and technical skills Strong written and verbal communication skills Excellent planning and organizational skills Able to understand the long-term strategic implications and short-term perspectives Able to negotiate demand with IT Business Partners and business clients Able to estimate the financial impact of architecture and platform alternatives Able to apply multiple technical solutions to business problems Able to quickly comprehend the functions and capabilities of new technologies Knowledge of financial management and budgeting

Customer & Industry Knowledge: Experience within the biotechnology/pharmaceutical industry required Knowledge of current and emerging technologies

Education/Training: Degree in the field of computer science or information systems or related field required

or equivalent combination of education and experience required. BA or BS degree preferred

License/Certification Required: N/A

Other Requirements Demonstrated leadership and business competencies that include: conflict/issue

resolution, meeting facilitation, analytical and organizational skills, multi-tasking, relationship building and decision-making skills

The ability to diplomatically drive process changes and best practices Exceptional communication and interpersonal skills Demonstrated ability to work well with others and be respected as a leader Track record for remaining unbiased toward any specific technology or vendor; and

being more interested in results than personal preferences Capable of being extroverted and collaborative Motivation that is focused on long-term results

Additional Information Posted:April 16, 2013 Type:Full-time Experience:Director Functions:Science Industries:Pharmaceuticals Job ID:5417860

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____________________________________________________________________ Quantitative Analysis Manager Onyx Pharmaceuticals - South San Francisco (San Francisco Bay Area) Job Description Quantitative Analysis Manager South San Francisco, CA Full Time/Direct Hire Do you want to work for a fast growing company with an executive team that is recognized as leaders in the biotechnology industry? Do you have the passion and drive to excel in what you do? Do have the business knowledge to make an impact on the strategic sales and marketing decisions for a group/department? Then look no further! Onyx is looking for a Manager of Quantitative Analysis to help with Business Intelligence from a strategies perspective. Headquartered in South San Francisco, CA, Onyx received FDA approval for two drugs in 2012. Our sales teams are now promoting 3 oncology drugs in 5 indications and as a result, Onyx is in explosive growth mode! In 2012, we hired 300+ new employees and we are poised to hire another 250+ in 2013. Onyx has received awards for our overall performance as a company, our contributions to the community and our patient advocacy. We have made the top 20 list in the MedAdNews 21st Annual Top 100 Biotechnology Companies List in June 2012 and we were awarded the Outstanding Product Award for Kyprolis™ (carfilzomib) for Injection at the Northern California BayBio Pantheon Awards in November 2012. What we are looking for?

Able and willing to hit the ground running. Jump right in and contribute! Looking for someone who can help with Business Intelligence from a strategies

perspective Experience with Business Intelligence, SAS and SQL - they would be heavily looking and

generating data for the sales team so that exposure is great! Here is the detailed job description for this position: Summary The Manager – Quantitative Analysis will support business intelligence strategy and initiatives by performing model based analytics on data sets of provider, account, system and GPO /Payer level in order to uncover insights for better utilization of resources, better decision making for sales force and program deployment and marketing mix/resource optimization. The role also includes requirements gathering, project management, data integration and data quality monitoring. He/she will partner with the Global Business Analytics team to provide analytics insights, such as account segmentation and prioritization, performance metrics and other elements to be used in forecasting and IC goal setting processes. This role will also generate reasonable assumptions in the absence of hard data. Overall, the Manager – Quantitative Analysis role will have an impact on strategic sales and marketing decisions from within Global Business Analytics department in support of Commercial Team initiatives. Essential/Primary Duties, Functions and Responsibilities

Collaborate with stakeholders across the commercial organization to determine key data needs, define assumptions, and share results

Perform advanced quantitative analyses (spreadsheet modeling, data analysis, etc.) o Be involved in design, development, and maintenance of multiple ad hoc queries

o Identify data dependencies and data integration points and collect business metadata o Participate in analyzing business processes, relational database modeling, dimensional data modeling, and database design o Employ statistical and Monte Carlo simulation methods to build models of key business processes and perform optimization and resource allocation recommendations

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Monitor and evaluate program processes and results to determine impact, communicate outcomes, and identify areas for improvement

Work effectively with stakeholders, shared service groups, peers, team members and other departments to accomplish company and departmental objectives

Lead and complete data analysis projects as a part of initiatives focused on identify sales and performance trends utilizing available data resources

Ability to support multiple projects simultaneously, adjusting priorities as needed and meeting deadlines

Other Duties as assigned. Desired Skills & Experience Requirements Work Experience: 3-6 years of analytical/ modeling and data mapping experience in pharmaceuticals with some exposure to oncology Prior experience analyzing pharmaceutical data either at a pharmaceutical manufacturer or consulting firm Very strong analytical and problem solving skills and experience; this position will involve both modeling and database analysis. Management of Staff: No direct management of full time staff, management of projects and vendor will be required Some familiarity with managing external consultants in subject areas of relevance to this role Functional/Technical Knowledge & Skills: SQL Writing experience (Oracle, MS Access, SQL Server) SAS (preferred) or SPSS experience at either the PC or Server level Familiar with relational database Gathering and documenting business requirements Strong working knowledge of presentation software, including MS Excel, MS PowerPoint, MS Project, and MS Visio Customer & Industry Knowledge: Experience with Business Intelligence reporting tools Understanding of marketing and business analytical concepts Education/Training: Bachelor’s in a quantitative discipline ( Engineering, Social Science, Economics, etc.) MBA/ MSc Preferred in similar disciplines PhD not needed but desirable Relevant business training at prior employment roles Other Requirements: This role is expected to be a strong team player as well as a BI advisor within the GBA organization. H/She must have excellent written and oral communications skills, and a proven ability to analyze, organize and integrate large amounts data into clear concise presentations through technical translation of business requirements, analysis and report development. Previous business intelligence, SQL programming and analytical background required. Experience succeeding in a very fast paced and dynamic work environment

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Self-motivated, self-disciplined and results-oriented Understanding of marketing and business analytical concepts Competencies

Develop presentations to communicate findings, illustrate key insights, and influence decision-makers

Communicate and coordinate with internal customers, vendors, and others, as necessary

Ability to work collaboratively within the team and with other teams to gather inputs, overcome obstacles and share results

Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Job ID:5417804 ************************************************************************ Apply on company website Process Expert_Manufacturing site Novartis Pharmaceuticals- San Francisco Bay Area Job Description Supports the PU in all process-specific issues, drives continuous process improvement for quality and quantity and ensures GMP requirements are met and guidelines and SOPs are followed. Major Accountabilities (Describe the main results of the job to be achieved ) • Provide continuous supply of high quality products that meet technical specifications, cGMP, regulatory policies and procedures. • Root cause analysis and investigation for deviations and complaints (external and internal). • Lead and/or support of decision making for manufacturing problems. • Continuous process verification (establishes QRAs, performs process monitoring). • Provides input on process performance for APR/PQRs. • Lead and team member for quality and productivity projects. • Subject Matter Expert (SME) for inspections and audits (healthy authorities, internal inspections) according to product responsibility. • Support of launch projects; contact person for development and validation team from manufacturing. • Author and reviewer for SOPs. • Ensures productivity is aligned with schedule. • Responsible for managing deviations. • Preparation and performance of operator trainings and monthly deviation CAPA training. • Initiation and implementation of change requests. • Support for KPI improvement (e. g. TPT, OAE, yield, right first time etc.) • Authoring of process and GMP risk assessments. • Ensures that manufacturing is according to GMP guidelines and within registered and validated specifications. • Establish and maintain master batch records (including bill of material). • Responsible for SOPs. • Ensure manufacturing procedures are in compliance with Health Safety and Environ-mental

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guidelines. • Supervision of trainees. Desired Skills & Experience -Bachelors in Science or Chemical Engineering -English (fluent, oral and written) - A minimum of 10 years experience in the pharmaceutical/chemical industry. Knowledge of a process oriented organization and self-directed culture a plus. Requirements: • Carrying out Planning and Monitoring activities • Motivating, leading and influencing others • Effective problem solving and decision making • Collecting, analysing and evaluating information • Communicating effectively (e. g. moderation of a meeting) Specific Professional Competencies: • Detailed knowledge of GMP • Detailed knowledge of processes and company guidelines • Product knowledge • Very strong analytical skills, scientific and statistical knowledge to identify root causes of product failures. • Knowledgeable of industry HS&E standards (process safety handling of hazardous materials).. • Project management skills • Application and knowledge of risk management • Application of Lean Manufacturing principles. • Presentation and moderation skills • Working knowledge of process improvement tools. • Coaching and motivation skills, indirect personal management skills • Knowledge of technical change management • High flexibility and endurance • Ability to handle conflicts • Knowledge of MS office, SAP, Track wise, Company Description Novartis provides healthcare solutions that address the evolving needs of patients and societies – products to prevent and treat diseases, ease suffering and enhance quality of life.<br><br>The Novartis portfolio focuses on science-based healthcare sectors that are growing and reward innovation, such as pharmaceuticals, eye care, generics, vaccines and diagnostics, over-the-counter (OTC) and animal health.<br><br>Novartis is the only company with leading positions in each of these areas. Novartis research is driven by a distinctive clinical and scientific strategy focusing on unmet medical need and knowledge of disease. <br><br>Corporate social responsibility is an integral part of how Novartis operates and key to our success. We focus on improving access to healthcare globally, and our Malaria Initiative has become one of the largest access-to-medicine programs in the healthcare industry, as measured by patients reached. <br><br>Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 121,000 associates and operate in more than 140 countries around the world. Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Manufacturing Industries:Pharmaceuticals

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Compensation:DOE Job ID:5626711 _________________________________________________________________ GMP Officer_Quality Manager_12 hour shifts Novartis Pharmaceuticals- San Carlos, CA (San Francisco Bay Area) Job Description Supports day to day site compliance needs on the shop floor. Identifies and resolves compliance issues within the Process Unit unilaterally and cross-functionally. Works closely with the Process Units and Quality Organization to ensure compliance with current FDA regulations through operational oversight, internal audits, deviation management, and proactive process improvement initiatives. Assists with Regulatory Agency inspections/ activities, as needed. • Responsible for ensuring compliance with Federal (FDA, EPA, OSHA), State and local regulations. Ensure and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection. • Responsible for commercial product release. • Provides general oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise. • Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level. • Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers to determine root causes and corrective actions to resolve complex, compliance related issues. (product failures, stability failures, and compliance issues, including supplier investigations). • Evaluation and decision of deviations reports in AQWA (trackwise) compliant with cGMP guidelines and SOPs, while escalating the decision for critical /major deviations to QA management. • Drives timely resolution of deviations, disposition of batches and escalates in case of delays within the Process Unit. • Support Quality Assurance and GQO with internal audit coordination, response, and follow-up activities. • Evaluate current operational practices and recommend process improvements to ensure continued compliance to regulatory requirements and industry expectations. • Actively participates in process improvement teams/initiatives Participate in or lead internal/external audits, as needed. • Compilation of data and information for contribution to Risk Assessments and Reports (e.g. APR/PQRs). May actively author risk assessment and reports. Authoring and revision of SOPs where in the departments area of responsibility. Desired Skills & Experience Bachelor degree in a scientific discipline. Equivalent experience may be accepted. • A minimum of 8 years of related pharmaceutical experience. • Experience in Deviation Management and batch disposition. • Auditing and technical report writing experience. • Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations. • Excellent oral and written communication skills required. • Very good user knowledge for Microsoft Word and Excel. SAP and Trackwise knowledge a plus. • Demonstrate leadership ability and excellent interpersonal skills. • Ability to work under minimal direction, independently or as part of a team if necessary.

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Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Other Industries:Pharmaceuticals Compensation:DOE Job ID:5626669 ___________________________________________________________________ Associate Director of Regulatory Affairs Novartis Pharmaceuticals - San Carlos, CA (San Francisco Bay Area) Job Description Directs the regulatory activities that support site and company projects and programs. Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products, medical devices and medical device/pharmaceutical combination products under development or license for assigned projects. Provides regulatory guidance and leadership to USSC and partner-sponsored project/program teams. Manages internal staff and external resources to ensure quality and timeliness of submissions. Coordinates, prepares, edits and submits applications to regulatory authorities. Serves as principal regulatory contact with corporate partner programs and for Novartis at partnered meetings with regulatory agencies; primary regulatory representative to US and ex-US regulatory agencies for routine interactions. May select, develop, and evaluate personnel to ensure the efficient operation of the function. Act as a combination product and medical device expert and contact for identified TAs and for the Department, and external line units in a specific area of expertise. Within the area of expertise and beyond, promote awareness within Novartis of worldwide legislation/guidelines, ensure proactive participation of the company in opportunities to comment on draft legislation/guidelines, promote best practices and provide training to Reg CMC, DRA, Development and ESO/TechOps. Ensure, consistency of regulatory strategies and documentation and strong Reg CMC participation in interdepartmental meetings, in cooperation with Management team and group heads. Advise Reg CMC and line functions by taking into consideration regulatory issues, trends and processes for medical devices and combination products. For projects within own responsibility, independently provide and drive global and regional regulatory strategies for complex submissions and/or highly strategic projects/products covering development, registration and approval/post approval activities as assigned. Essential Duties and Responsibilities: • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. • Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. • Establishes and assures adherence to budgets, schedules, work plans and performance requirements. • Responsible for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.). • Works with project teams and department management to develop regulatory strategies,

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identify regulatory risks, and enable earliest possible approval. • Ensures that submissions meet format and content requirements applicable to specific health authority regulatory requirements (i.e., US, ICH, and ROW, ISO, IEEE, ASTM, etc.). • Provides input on, and reviews specifications, methods, SOPs, protocols, reports, labeling, and etc. for regulatory compliance. • Supports design control for project teams in the Regulatory role. • Provides direction and requirements to internal staff to ensure high quality output and timely project completion. • Ensures that documentation for all projects is maintained and kept current. • Identifies Regulatory Affairs' SOP needs and discusses with site head/department. • Drafts and reviews local Regulatory Affairs' SOPs and global medical device/combination product SOPs. • Participates in, and provides regulatory guidance, strategy and leadership to working teams (both internal and partnered programs), Project Teams (Core), and Company Management. • Serves as principle regulatory contact with corporate partner programs, and contract manufacturers. • Develops and maintains timelines for department initiatives and corporate goals. • Manages timelines for regulatory submissions. • Functions as primary contact for project related interactions with US and Ex-US regulatory agencies for partner and internal programs. • Solves problems of significant levels of complexity following established company policies and procedures; informs management of impacts. • Works independently to complete assigned projects; keeps management informed on progress. • Negotiates, interacts and supervises the activities of contract organizations and consultants in the preparation of regulatory submissions as necessary. • Advises department, project teams and company on issues related to regulatory strategy; identifies areas of concern in regards to developing regulations. • Provides input on Regulatory Affairs department activities, including but not limited to; staffing requirements, budget proposal and tracking, regulatory SOPs, training requirements, documentation retention policy and implementation, and etc. • May be responsible for conducting performance reviews, and providing feedback and coaching to direct reports. • Single point of contact for USSC regarding dissemination of new regulations and guidelines. • Responsible for driving consistent and creative regulatory strategies and for sharing with management and others within Reg CMC, within matrix responsibility (TA, or other topic of expertise) and beyond. • Within area of expertise, provide training, coaching and advise to Reg CMC and other line functions and promote awareness of worldwide medical device & combination products legislation/guidelines. • Within area of expertise, ensure proactive participation of the company in opportunities to comment draft legislation/guidelines. • Facilitate consistency in regulatory strategies and documentation by critically reviewing CMC documentation, coaching, participating in Reg CMC challenge meetings and integrating regulatory trends and experiences. • Lead or participate in multidisciplinary teams focusing on continuous improvement and management initiatives. • Represent Reg CMC in interdepartmental meetings, working groups and initiatives. • Represent Reg CMC in Due Diligence and Divestment Teams. • Increase awareness of Reg CMC contributions to other line units by educating them in the critical points of CMC strategies and documentation and by providing training/guidance. • Hold Lessons Learned sessions within and external to Reg CMC leading to improved strategies and decisions on common regulatory approaches. Ensure information is archived and

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available. • Represent Reg CMC aspects within TRD-EP, TRD-LP, CPIC meetings etc. • Act as a senior member of the section or department with a function or specific skill set supporting the Group, Section or Department Head, as appropriate; assist Group Head/Section Head in coaching and training other associates within department as necessary • For projects/products under responsibility, proactively communicate regulatory strategy, key issues and any other critical topics throughout life cycle in an adequate and timely manner to the project team and to appropriate management level in TechOps, DRA and TRD as appropriate. Provide strategic regulatory guidance, advice and training to line units within Development and TechOps. • Lead cross-functional Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, as appropriate. • Lead preparation of CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions under own responsibility. • Ensures compliance with GMP/HSE regulations, Novartis policies, procedures and standards as appropriate for the role. Champions a Quality Culture and ensures a safe working environment. Desired Skills & Experience • A minimum of a Bachelors degree in a scientific discipline is required. An advanced degree is preferred. Equivalent experience may be accepted. • A minimum of 10 years experience in the pharmaceutical or other related industry is required. • Minimum of 7 years hands-on Regulatory Affairs experience in the pharmaceutical industry dealing with combination products and/or medical devices. • Experience in the respiratory therapeutic area a plus. • Strong verbal and written communication skills are required, as well as presentation skills; must be able to present departmental policies and practices. • Must be detail- and goal-oriented, quality conscientious, and customer-focused. • Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines. • Experience working in a multi-disciplinary team environment is required. • Ability to manage changing priorities multiple tasks, and to communicate impact to project teams is required. • Strong computer skills in Word, Excel, PowerPoint and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset; can use Internet for research applications. • Must possess an understanding of cGXP regulations and provide guidance to project teams on regulatory compliance issues. • Knowledge/experience of worldwide regulations, guidelines and regulatory processes for NCEs and product life cycle maintenance. • A good understanding of chemistry, analytics and pharmaceutical technology and in-depth understanding of the drug development process. • Proven track record of early recognition of potential Regulatory CMC issues, distilling complex situations, sound risk assessment and overcoming hurdles. • Ability to work in cross-functional and international environment. • Strong team player. • Proven track record of strategic thinking maintaining awareness of business impact. • Proven track record of successful risk assessment. • Respected subject matter expert within department and external line functions. Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level

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Functions:Other Industries:Pharmaceuticals Compensation:DOE Job ID:5626624 ********************************************************************** Apply on company website Senior Software/Scientific Quality Engineer Ingenuity Systems- San Francisco Bay Area Job Description POSITION SUMMARY As a Senior Software/Scientific Quality Engineer, you will work with a dynamic and hard-working team to help improve the quality of our flagship systems biology product, Ingenuity Pathways Analysis as well as other Ingenuity products (Variant Analysis and iReport)and services. You must observe and constructively work towards improving the overall product quality, testing and risk management process. You will work closely with developers, product management, customer service and other internal groups to proactively seek product information, develop in depth test plans, derive practical use cases, and author appropriate test cases. You will also be responsible for communicating risks, test status and results to QA, Development, and Management. You will perform functional black box testing as well as white box and test automation where applicable. DUTIES & RESPONSIBILITIES Essential Functions:

Scientific testing of biological content through Ingenuity Software Develop test automation scripts using Java based automation tools (FitNesse, Selenium,

etc) Conduct functional-level testing including both GUI and backend tests Involvement with Agile iterative software development process - test-driven

development, continuous integration testing, rapid automation to efficiently build the best industry software

Interpret requirements and specifications to develop test plans, test cases and test documentation

As an individual contributor, hands-on involvement in all areas of Quality Assurance: processes, test plan and test case creation, bug tracking lifecycle, and functional testing

Think from a customer perspective, and creatively solve real user problems Marginal Functions:

Make recommendations for QA process, best practices and other implementation according to business goals

Recommend and implement enhancements to our automated testing framework Coordinate and lead efforts for cross functional testing and/or integration tasks on a

project basis Desired Skills & Experience KNOWLEDGE, SKILLS, & ABILITIES Minimum:

Strong knowledge of molecular biology and genomics Proficiency with Java or other object-oriented programming languages, automation with

WebDriver (Selenium 2), Unix and Windows operating systems, and experience with testing web-based and java-based applications

Experience in both white and black box testing, and with performance/load testing web apps

Familiarity with SQL and database design, with version control software like CVS or Subversion, and with defect-tracking software and processes

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Experience developing test plans, designing, implementing, executing and analyzing test cases, writing bug reports, and assessing risk

Preferred: • Scripting experience with Perl or Python • Experience in test automation using Silk Test, Fitnesse

Strong experience with analysis of algorithms, statistical analysis skills and understanding Agile Development Methodologies

Experience with multi-tiered web technologies including web servers and application servers

Experience with or interest in working with life sciences: • Familiarity with the bioinformatics field and with computational biology tools and practices • Familiarity with viral and bacterial pathogens, host-pathogen interaction, disease response, infection and inflammation pathways • Experience working with data from Next Generation Sequencing (NGS) platforms • Familiarity with ontologies, specifically bio-ontologies (GO, MeSH, UMLS) • Familiarity with general bioinformatics databases and computational biology resources (NCBI Entrez Gene, KEGG, PubMed) EXPERIENCE Minimum:

3+ years experience in biotech or bioinformatics Preferred:

2+ years experience in molecular biology research 3+ years experience in test automation

EDUCATION Minimum:

M.S. in Molecular Biology (biology, biochemistry, genetics) or equivalent industry experience.

Preferred: B.S. /M.S. in Computer Science or equivalent industry experience. PhD in Molecular Biology

Company Description Founded in 1998 by Stanford graduate students, Ingenuity Systems is a company that is taking on the challenge of next-generation knowledge management for the life sciences community. Our long-term focus on innovation in semantic search, ontology, and software development has allowed us to create groundbreaking technologies that help life science researchers more effectively search, explore, visualize, and analyze biological and chemical findings related to genes, proteins, and small molecules (e.g. drugs). Today, Ingenuity's products are used by thousands of researchers at hundreds of leading pharmaceutical, biotechnology, and academic research institutions worldwide. We are continually looking for new ways to develop and leverage our technology in order to address needs within the constantly evolving life science market. With such a strong focus on our customers, Ingenuity has developed a loyal and passionate user base that is the core of the company's success in this dynamic and evolving market. Ingenuity is headquartered in Redwood City, California and has offices in Germany, Switzerland, France, the United Kingdom, and Japan. Additional Information Posted:May 2, 2013 Type:Full-time Experience:Mid-Senior level Functions:Science, Quality Assurance, Information Technology

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Industries:Biotechnology, Computer Software, Information Technology and Services Job ID:5598245 ____________________________________________________________________ Marketing Programs Manager Ingenuity Systems- San Francisco Bay Area Job Description Ingenuity Systems is seeking a Marketing Programs Manager for Variant Analysis. Ingenuity Variant Analysis is a web application that helps researchers studying human disease to identify causal variants from human sequencing data. The Marketing Programs Manager will drive multiple, concurrent demand generation campaigns for prospecting and lead nurturing, from strategy definition through tactical execution. Campaigns will span a variety of offline and online marketing communication vehicles including emails, banners and social media. The ideal candidate is a creative, natural leader, who is metrics driven and possesses a strong ability to drive and project manage a wide range of initiatives. Must have strong prioritization skills, be self-directed, excellent communicator, results oriented and flexible, experienced in both strategic development and closed-loop campaign execution. Specific responsibilities include: Strategic development of campaigns, including audiences, messaging, offers, reach vehicles, frequency, campaign timing and flow, A/B testing, and forecasted metrics Campaign execution, including:

Setting up, testing and launching campaigns through list brokers, media partners, and Marketo

Reporting on campaign metrics / results, link tracking and closed-loop management of campaigns

Creative development (creative wireframes and copywriting) of emails, banners, landing pages and thank you pages

Coordination with design resources to produce the campaign artwork Developing and managing the demand generation campaign calendar Interfacing cross functionally to manage or gain approval on copy and offers Leveraging existing content and/or developing new content (copy and offers) List pulls, rentals, purchases Providing campaign insights, feedback and best practices

Desired Skills & Experience Qualifications:

4-6 years’ combined B to B marketing communications and demand generation experience in life sciences or high tech software (must have)

Strong project management and prioritization skills Experience with Marketo (ideal) Experience with Salesforce.com is helpful Experience with social media as a marketing tool (Facebook, twitter, blogs, target

audience related community sites) is a plus Requires solid writing, content development and editing skills – ideal candidate has

experience messaging to and reaching the academic life sciences audience Must be experienced with researching and procuring target audience lists Requires both strategic development and hands-on tactical execution expertise Proficiency with the Microsoft Office Suite BA/BS in marketing, communications, general business or similar Familiarity with next generation sequencing technologies

Additional Information Posted:April 19, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing, Product Management, Sales

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Industries:Biotechnology, Computer Software, Information Technology and Services Job ID:5469852 Veteran Commitment

Ingenuity Systems commits to hiring returning veterans ******************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5657923&trk=eml-anet_dig-b_premjb-ttl-cn&ut=09qnlajsAw0lM1 Sales Manager - Life Science and Diagnostic Tools Fluxion Biosciences- San Francisco Bay Area Job Description Fluxion is currently looking for an experienced Sales Manager to lead the commercialization effort for the recently-launched IsoFlux System. This position is an excellent opportunity for an experienced sales professional to take on a leadership role in the rapid commercial growth of a new instrumentation platform that will have a major impact in the field of cancer diagnostics. The successful candidate will be a natural ‘closer’ and contribute to both sales and business development activities as well as serving as a sales liaison to the project and management teams. This high visibility position will focus on the commercial adoption of the IsoFlux System within university, research center, biopharma, and clinical lab sites. The ideal candidate will have a background in sales and business development in the life science tools and diagnostics industry. A strong, verifiable track record of closing sales opportunities and exceeding projections is imperative for this role. This is a consultative sales role – the ideal candidate will able to maintain a high degree of technical knowledge and interact with high level customers across a variety of institutions. Location: This position will be based out of Fluxion’s South San Francisco, CA headquarters. Consideration will be made for exceptional candidates that are based out of other key geographies. The Sales Manager will:

Maintain responsibility for hitting the sales targets of the IsoFlux System, both in the US and internationally

Manage the sales pipeline by accurately tracking sales opportunities according to customer segment and progression towards closing

Pursue sales prospects coming from a variety of sources (marketing and business development activities) by offering sales presentations, technical consultations, evaluations, etc.

Work closely with the product and technical teams (field and in-house application scientists) to address customer inquiries and product evaluations

Conduct negotiations surrounding purchase orders, placements, etc. and ensure timely closing of opportunities

Analyze the key metrics surrounding progression of sales opportunities and be prepared to make recommendations to optimize the sales cycle and product positioning

Work closely with Fluxion’s network of international distributors to maintain sales targets in their geographies and close individual sales opportunities

Identify new areas of commercial growth for the existing IsoFlux product and make recommendations for future product development

Represent the product and company at US and international conferences and trade show exhibits

Identify and pursue sales and business development channels beyond single institution sales, including: OEM, private label, CRO/Reference Lab, and Dx partnerships

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Desired Skills & Experience This job will require the following attributes:

Bachelors level degree in the biological sciences or engineering (MS, MBA, or Ph.D. preferred)

A MINIMIUM of 5 full years of post-graduate experience with a life science tools or diagnostics company

A MINIMUM of 3 full years of experience in a direct sales role for instrumentation / capital equipment (>$10K) with ownership of territorial or product sales number

Additional experience in marketing, business development, and/or product development preferred

Direct experience as a sales professional with a company in any of the following areas: o Oncology diagnostic instrumentation o Biomarker testing / diagnostics o Sequencing instrumentation or reagents o qPCR / dPCR / multiplexed PCR instrumentation or reagents o Pathology / microscopy instrumentation o Ability to work both independently and within the team structure, good

teamwork attitude a must o Ability to work in a fast paced and changing environment o Flexible and quickly adaptable to changing priorities o Excellent written and oral communication skills and meticulous record keeping o Experience with sales CRM platforms (Salesforce preferred) o Moderate travel (20-40%) required to cover customer visits, conferences, and

international distributors Company Description Fluxion Biosciences is a rapidly-growing bioanalytical tool company that is addressing critical needs in the pharmaceutical, biotech, diagnostics, and life science research markets. We are looking for individuals who will thrive in a fast-paced environment and can make meaningful contributions to the development and commercialization of our line of products for cellular analysis. Fluxion offers competitive salary, stock options, and a comprehensive benefits package (health, dental, vision, FSA, and more). Additional Information Posted:May 8, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development Industries:Biotechnology, Medical Devices, Research Job ID:5657923 ********************************************************************** CHRIS WALERY, Recruiter WorkbridgeAssociates | Where People Meet Performance CONTACT Chris.walery@workbridgeassociates.com W: (949)833-1300 CONNECT Twitter: https://twitter.com/#!/ChrisWalery Linkedin: http://www.linkedin.com/pub/chris-walery/36/86b/444 Website: http://www.workbridgeassociates.com/ Workbridge Orange County | 4675 MacArthur Court, Suite 960 ,Newport Beach, CA 92660

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I work for a specialized recruiting firm in Newport Beach that specializes in placing electrical engineers and software engineers in Orange County and I am working with some very interesting companies right now and they are all in an aggressive growth mode. That being said, I am working with a cutting edge medical device company in Irvine that is looking for an experienced Director of Engineering. Our client is a leader in medical device instrumentation and surgical tools and has been at the fore front of cutting edge medical technology for over 20 years. They are looking for someone who has experience working in the Medical Device field and who has been either a Senior Manager or Director of Engineering and has managed engineers for new product development. *********************************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5626849&trk=eml-anet_dig-b_premjb-ttl-cn&ut=2LNPfoQdw50lM1 IT Services Manager Onyx Pharmaceuticals- San Francisco Bay Area Job Description Onyx is looking for an IT Service Manager to act as a liaison between different peers within IT operations and support. Headquartered in South San Francisco, CA, Onyx received FDA approval for two drugs in 2012. Our sales teams are now promoting 3 oncology drugs in 5 indications and as a result, Onyx is in explosive growth mode! In 2012, we hired 300+ new employees and we are poised to hire another 250+ in 2013. Onyx has received awards for our overall performance as a company, our contributions to the community and our patient advocacy. We have made the top 20 list in the MedAdNews 21st Annual Top 100 Biotechnology Companies List in June 2012 and we were awarded the Outstanding Product Award for Kyprolis™ (carfilzomib) for Injection at the Northern California BayBio Pantheon Awards in November 2012. What are we looking for?

An IT Service Manager who is detail-oriented, organised, huge collaborator, proactive, a good communicator et al

Someone who knows how to fix and make things better! Someone who has experience managing process, the operations of IT - making sure

whether we are doing what we are doing not just from a customer perspective but also from a staff perspective.

Here is the traditional job description for your reference: This position serves as the lead within the group, training, assigning and monitoring performance for a 24/7 department. The position is also responsible for taking, routing and troubleshooting for escalated calls\tickets, which includes operation of a multi-computer network and related peripheral equipment, communications equipment located both at Corp and in the field. This position uses daily and real-time reports\alerting to run day-to-day operations. Responsibilities:

Manage and collaborate our managed services and ensure that their performance and provision of services and quality are in line with our expectations and enable us to meet or exceed service levels;

Responding to incidents and requests, ensuring they are resolved effectively and efficiently against service level agreements;

Ensure that practices and processes exist and when it is possible are standardized and repeatable. Ensure that these ones are continually improving and produce business cases to support team activities;

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Identify and implement improvements to the Service Desk incident logging system in order to provide a more effective and efficient service to customers;

Ensure that the Service Desk is fully using appropriate knowledge management tools and practices in order to provide a more effective and efficient service to Onyx users;

Contribute to the success of the business and assist in improving the overall customers experience within the team;

Meet goals and KPIs as set by the IT management; Ensure that team’s KPIs are monitored, actions are taken, evaluated accordingly and

delegated properly; Review aspects for improvement with own practices and process

Desired Skills & Experience Work Experience: Eight plus years of professional, related work experience Management of Staff:

Experience with managing staff and/or managed services Functional/Technical Knowledge & Skills:

Strong computer skills (Windows XP, Windows 7, Word, Excel, Outlook, etc.) Strong knowledge of Windows XP Professional operating system in a networked

environment Strong understanding of ITIL Service and Service Delivery, Incident\Problem

Management, KB, and Service Catalogs. Customer & Industry Knowledge: Life Science, GxP, Compliance Education/Training:

Bachelor’s degree, technical certificate or equivalent. PMP or fundamental understanding of Project Management a plus

Other Requirements: Advanced level of time and priority management skills a must Ability to work independently and appropriately prioritize multiple tasks from all

departments Advanced critical thinking skills Must be organized and have the ability to handle a large number of rapidly changing

priorities and exhibit excellent flexibility and follow-up skills Excellent written and verbal communication skills Professional interaction and teamwork with others Must have strong interpersonal skills, with the ability to work with many levels of

management Ability to troubleshoot remote laptops via telephone Willingness to work flexible hours to ensure helpdesk coverage and task completion

Additional Information Posted:May 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Pharmaceuticals Job ID:5626849 ****************************************************************** Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions

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Contact cheryl@biophaseinc.com if interested, and visit www.biophaseinc.com to view all our current opportunities! Associate Project Coordinator (El Dorado Hills) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Associate Project Coordinator to work for a leading Bay Area biotechnology company. Associate Project Coordinator BioPhase Solutions is seeking a candidate for a Scientific Associate Project Coordinator. This position is located in El Dorado Hills, CA, and is contract with possibility of conversion to regular. RESPONSIBILITIES: Set up client and project specific files. Assisting Project Coordinator and/or Project Manager with sample receipt, sample reconciliation, tracking and storage, any necessary communications to site or sponsor. Table generation and final analytical report that is written according to SOPs and ready for QAU review. Quality control review of data tables, and validation and bioanalytical reports. Additional responsibilities within project management with proper training. Responsible for following GLP guidelines and laboratory SOPs and maintaining a safe working environment. QUALIFICATIONS: Bachelor’s degree (BA or BS) preferred; or 2 years of college courses in a scientific discipline. 1 year of relevant experience in data management preferred. Possess a sound background in GLP compliance, knowledge of GCP and other regulatory standards, applicable guidance documents and white papers. Local candidates to the El Dorado Hills area. Relocation is not provided. ********************************************************** Posted by Cynthia Williams, Director of Business Development and Recruiting at Compass Consulting Group If you are a Sales Reporting Manager with the above experience, please RUSH your resume to cwilliams@compasscgroup.com for immediate consideration! SF East Bay Area Biotech leader seeking FTE Sales Reporting Manager... Our San Francisco East Bay biotech client is seeking an experienced Sales Reporting Manager to join their Business Analytics team. The Sales Reporting Manager will project manage, develop, deploy and govern an online strategic sales reporting tool, leading a large sales reporting project, and interfacing with sales and marketing, IT and outside vendors to upgrade sales reporting tools, ensure data integrity, and scope out data strategy business needs. Requirements: 1. Prior experience with sales force reporting project, preferably in biotech, and 5+ years working experience in sales reporting and/or BI systems integration in industries such as Healthcare, Pharmaceutical, Medical Device, or Consumer Packaged Goods. 2. Experience with systems integration of CRM tool solutions (Salesforce.com, Cognos BI, Siebel, or SAP) required.Strong understanding of relational databases required with experience managing IMS, SDI, Wolters Kluwer databases preferred. 3. Prior history of successful project management of large capital projects (>$500k in capital)

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and systems integrations for sales reporting solutions required. 4. Candidate must have experience directly interfacing with sales reps and/or account managers. *********************************************************** Apply on company website Pharmaceutical Engineer III- Gilead Sciences - Foster City- Job No- 10805 Reporting to the Associate Director, Pharmaceutical Manufacturing, the Pharmaceutical Engineer III works as team member with Formulation and Process Development, Quality Assurance, Materials Management, Regulatory Affairs, Project Management, and staff from other functional areas to meet complex project deliverables such as new product launches or start-up of new manufacturing sites while ensuring uninterrupted commercial product supply. Essential Duties and Job Functions: • Develops strategies to implement changes to processes. • Interfaces with contract manufacturers to address standard documentation and compliance issues. • Contributes to organization processes across functions and interacts effectively with the other team members. • With guidance, prioritizes own work to ensure conformance to departmental goals. • Writes internal procedures required to ensure GMP compliance. • Supports and revises specifications and resolves technical issues with material suppliers. • Prepares documents for Regulatory filings. • Responsible for planning and implementing activities on projects related to scale-up, validation, and technology transfer between sites. • Supports discrete aspects for the specification, installation, utilization, qualification, and improvement of equipment used for solid dose and liquid products. • May oversee equipment/process qualification (IQ/OQ/PQ) and validation (PV); may write qualification/validation/technical reports. Requirements • 6+ years of relevant experience and a BS or BA. • 4+ years of relevant experience and a MS. • Prior experience in pharmaceutical industry is preferred. • Proficient knowledge of Good Manufacturing Practices (GMPs). • Audit and Investigation Skills, Report Writing Skills. • Strong verbal, technical writing and interpersonal skills are required. • Proficiency in Microsoft Office applications. • Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents. ____________________________________________________________________ Facilities Project Engineer III- Gilead Sciences - Foster City Job No. 10441 Reporting to the Facilities Engineering Manager, the Facilities Project Engineer III is responsible for providing engineering and project management services for laboratory construction projects at the Foster City campus. For small to medium projects, they will lead the effort from concept to construction closeout. For other projects, they will support other project engineers as needed. This is a critical and exciting position on a rapidly growing campus. Essential Duties and Job Functions:

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- Ensures effective communication between Project Stakeholders, Engineering, Space Planning, Maintenance, Site Services, Security, IT, Quality, Purchasing, EH&S, Finance, and Legal. - Compiles and analyzes statistical data to determine the feasibility of buying products and to establish price objectives. Makes recommendations to senior managers based upon evaluation. - Participates in project management through the entire work flow including scope development, schedule, financials to upgrade facilities and equipment. - May establish project teams, develops project strategy, master scheduling, spending forecasts, logistics systems, including RFQ's, bid selection, award of purchase orders, and invoice approval. - Manages the process to secure executed contracts, purchase order terms and conditions, insurance certificates, bonds, and other documents as required to protect the interests of Gilead. - Reviews and approves project plans, specifications, and submittals to ensure equipment and facilities are constructed to proper requirements. - Ensures projects are executed in accordance to Gilead Policies, Federal/State/Local Codes, Industry Best Practices, safety codes and cGMP requirements. - Works on engineering planning, financial justification, start-up activities, scale up processes, implementation, process improvements, and validation. - Generates and reviews required engineering and documentation. Provide accurate budget estimates for capital equipment and projects. Independently resolve engineering issues of complex scope. - May provide guidance to other project engineers, maintenance/calibration technicians, and EH&S personnel. - Confers with vendors and analyzes vendors' operations to determined factors that affect prices and determines lowest cost consistent with quality, reliability, and ability to meet required schedules. - Reviews proposals, negotiates prices, selects or recommends suppliers, analyzes trends, follows up ordered placed, verifies delivery, approves payment, and maintains necessary records. - Investigates and elicits client requirements and specifications for projects and ensures that business drivers are clearly defined and communicated. - Generates project standards and updates existing documentation standards. Requirements BS degree in Engineering and minimum of 5 years of relevant experience in related field. An MA/MBA degree can be substituted for 1 year of relevant experience. - Experience with design and operations of Mechanical, Electrical, and Plumbing (MEP) Systems and working in cGMP environment. - Possess strong leadership, project management, negotiation and communication skills. - Must be familiar with Autocad, MS Office applications, MS Project, Oracle Enterprise Systems, Siemens Apogee Products and System Architecture/Programming. - Must have experience and knowledge of Fire/Life/Safety systems, HVAC systems, with regards to their design and operation. - Experience in design and implementation, planning and schedule, and project management of small to medium capital projects and facilities equipment upgrades. - May coach and mentor junior engineers. - May manage and coordinate resources across different teams. ******************************************************* *************************************************************************

Other Information for Those in Transition *************************************************************************

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*********************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:

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1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are

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careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

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About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************* Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.”

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The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/

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Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************