JobsThatCrossedMyDesk March 17, 2013 - Audrey' s Network file3/17/2013 · Jobs That Crossed My Desk...

Jobs That Crossed My Desk Through March 17, 2013 Complimentary Service of Audreysnetwork.com

March 17, 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.

******************************************************** FTE (Full time) positions (San Francisco Bay area): Medical Information Manager Director Drug Safety Bioinformatics Associate Director CMC Regulatory Manager CMC Regulatory Statistical Programmer (Multiple openings up to the Associate Director Level) Medical Writers/ Medical Writing Managers (Sr) GCP Quality Specialist GCP Quality Manager Quality Validation Specialist Quality Specialist (batch record review experience) Project Manager Diagnostics Regulatory Project Manager Director Asia CMO Quality (Senior) Clinical Program Manager (Sr) Clinical Trial Manager SCRA (Sr Clinical Research Associate) Texas: Clinical Research Associate (Medical Device experience) And these CONTRACT openings in the (San Francisco Bay area): (Note that most of our contract jobs are Contract to Full time hire) Clinical Trial Manager (Contract) Clinical Site Contracts / Budget Coordinator (Contract) GCP Quality Specialist (Contract)

3/17/2013 2

Quality Specialist (batch record review experience) Quality Validation Consultant Document Control Specialist CONTRACT POSITIONS ELSEWHERE

Southern California

Marketing Operations Specialist Interaction Designer

T Technical Writer U User Experience Designer T Technical Publications Writer S Senior Administrative Assistant S Specialty Receptionist T Technical Writer / Editor C Community Relations Coordinator

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

Clinical Pharmacist (Inpatient), Department Of Veterans Affairs, Palo Alto, CA

http://www.pharmacyweek.com/career/26771/Clinical-Pharmacist-Inpatient-California-Ca-Palo-Alto

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

Apply Deb Denardis [email protected]. Come join an amazing company and supportive team as we all grow together.

Agilux Laboratories is looking for a Director of Business Development in California

Agilux labs is hiring a Director, Business Development-California area. Must be AGGRESSIVE Identify and develop new business opportunities in CA. Generate annual sales to meet or exceed the sales target for the territory.Conduct cold calls.Develop and maintain long term client relationships. Bachelor’s Degree, preferably in Science. Enthusiastic individual with strong customer service orientation.4 years emonstrated success in business development in CRO or pharmaceutical industry.

************************************************************** Apply on company website

3/17/2013 3

1) Manage staff from hiring to training to firing represents an important job of product sales managers 2) Maintain and increase sales of the company's products Product Sales Manager ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Descriptio 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: [email protected] (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 3) Ensure that all sales representative activities are in accordance with the guidelines of the company's code of conduct 4) Observe the performance of medical representatives in the field on a regular basis 5) Co-ordinate proper company resources to ensure efficient and stable product sales results 6) Establish and control budgets for product sales promotion and trade show expenses 7) Develop specific plans to ensure revenue growth in all company's products 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. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-88629 TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine,

3/17/2013 4

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: [email protected]

Additional Information Posted:March 11, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11169188629 Job ID:5073452 __________________________________________________________

3/17/2013 5

Biologics Procurement Manager ( Purchasing / Sourcing ) 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: [email protected] (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Develop the company's supply-chain to ensure adequate supply of various biological tissue types needed to meet market demand 2) Manage business relationships with existing tissue collection sites plus expanding the network of suppliers to meet production requirements and enable introduction of new products 3) Develop the company's diseased tissue program and manage efforts with internal staff (Sales, Marketing and Operations) to ensure continuous supply of tissue meeting customer requirements 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. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again:

3/17/2013 6

http://www.mybiotechcareer.com/JD/Purchasing-Procurement-California-Biotechnology-Jobs-Careers-89903 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: [email protected] Additional Information Posted:March 11, 2013 Type:Full-time Experience:Mid-Senior level Functions:Purchasing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11169189903 Job ID:5073442 ******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5084379&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3GvNCl-nbzN5E1 Regulatory Affairs Publishing Specialist Pharmalink Consulting - San Francisco and San Diego (San Francisco Bay Area) Job Description Position Purpose:

3/17/2013 7

The Publisher is responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions to ensure delivery on all regulatory submission milestones and compliance with applicable regulatory obligations. Role Description: • Deliver project-specific paper and electronic submissions, including coordination and execution of publishing solutions that meet unique requirements of each submission and management of product delivery to regulatory agencies • Integrate data from various electronic or paper sources into either electronic or paper submissions using formats and styles essential for regulatory compliance •Collaborate effectively with team members to assemble, copy, quality check, and publish required documents. • Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluently with multiple dossier formats and publishing requirements as required • Liaise with project team representatives to ensure paper and electronic submission requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional markets • Define, investigate, and implement regional and global process efficiencies for paper and electronic submission publishing, including the evaluation of current processes • Lead or participate on global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions • Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level • Work with the team leaders to effectively forecast and manage project-specific resources utilizing flexible resourcing, and global load sharing as normal business practice • Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimens, such that regulatory and internal compliance is preserved • Define and implement standards and regional process efficiencies for submission publishing and project learning sessions to meet these standards • Responsible for incoming Health Authority correspondence as well as archiving of final submissions and agency acknowledgement receipts into regulatory electronic archive repository • Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues • Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites •Create and maintain templates for regulatory submissions. Desired Skills & Experience 5+ years Regulatory experience; specifically in a Publishing function Bachelor's degree Company Description Pharmalink Consulting is the No 1 choice for sustainable outsourcing for all Regulatory Affairs requirements. We can resource any Regulatory Affairs project – regardless of size and timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world. Unlike some other consultancies, Pharmalink specialises in Regulatory Affairs only. The business has become so specialised in the last 10-15 years, it requires dedicated teams of Consultants to meet the increasingly complex demands of local health authorities and keep abreast of all the changes that are constantly happening on a global and local market level. For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com

3/17/2013 8

Additional Information Posted:March 11, 2013 Type:Contract Experience:Associate Functions:Consulting Industries:Pharmaceuticals Job ID:5084379 ******************************************************* Connie Milburn [email protected] Marketing Assistant (or even an Associate Product Manager) One of my clients is looking for a Marketing Assistant (or even an Associate Product Manager). If you know of anyone searching for a new opportunity, I would love to meet them! ******************************************************* Principal Catheter Design Engineer wanted to let you know about job openings at Medtronic Ablation Frontiers LLC in California that you might be interested in: Principal Catheter Design Engineer – California at Medtronic Ablation Frontiers LLC http://www.mydevicecareer.com/JD/R-AND-D-Science-Product-Management-California-MedicalDevice-Jobs-Careers-89501 Please *do not* send me a resume directly – you will need to apply online at the link above. ******************************************************** Apply on company website Sr. Supplier Quality Engineer- AccessClosure -Mountain View, CA Req# 13-5806 Exempt Regular Full-Time PROFILE: Ideal candidate is an independent, well-organized self-starter who thrives in a fast-paced environment and can independently juggle work priorities. A relationship-builder, you take a creative yet efficient approach to product quality, establishing supplier evaluation criteria and accountability. You are comfortable making decisions under pressure and exhibit a calm, efficient presence when faced with escalated turnaround times and/or sudden changes in daily work demands. SUMMARY: Responsible for the Supplier Quality Control system. Partner with internal departments and Suppliers to efficiently deliver safe and effective medical device designs and processes for manufacturing in line with AccessClosure’s policies and procedures. This includes supporting project teams on new and existing process and product development activities to ensure that processes and products are designed and developed in accordance with customer, corporate and regulatory guidelines. DUTIES & RESPONSIBILITIES: • Responsible for the management of the Supplier Quality System: o Supplier approval process including off-site manufacturing suppliers o Schedule and conduct Supplier audits, including off-site manufacturing suppliers o Present quality metrics as it relates to Supplier performance to Senior Management o Manage and investigate CAPA’s as they relate to Supplier quality performance o Direct interface with Suppliers relating to quality performance • Manage process improvements to the Supplier Quality System • Establishes measurement systems to monitor effectiveness of quality and reliability systems

3/17/2013 9

as they relate to supplier performance and component acceptance to identify, bracket, correct and prevent defects, presenting reports to management • Management of the NCMR system and facilitate MRB meetings • Assists with root cause analysis and corrective actions for Non-conformances related to components • Provide guidance to inspectors in the understanding of specifications, inspection technique and quality workmanship standards • Provides guidance to the engineering staff for the risk based approach to establish the sampling plan for components • Manages the quality related aspect for transition of manufacturing processes to off-site manufacturing suppliers • Represents the Quality department as a subject matter expert in External and Internal audits for Non-Conforming materials, Supplier Quality and other responsible areas • Assists with the document control process as it relates to components Requirements EDUCATION/EXPERIENCE: • BS in Engineering or related discipline • > 5 years related work experience with at least 3 years in the medical device field • Ability to perform multiple tasks concurrently with accuracy • Must have demonstrated hands-on experience in: o Auditing o FDA GMP o ISO 13485, 21CFR Part 820 • Clear and effective communication skills o Proficiency in MS word, Excel and PowerPoint o High attention to detail and accuracy is required • Working knowledge of SPC & Process Capability strongly preferred • Technical expertise in a commodity, such as extrusion or injection molding strongly preferred WORK ENVIRONMENT: • potential exposure to human bloodborne pathogens or other potentially infectious materials. • potential exposure to radiation sources such as fluoroscope in a catheter laboratory. • potential exposure to chemicals. • travel up to 25% (including some international) SUPERVISORY RESPONSIBILITIES: • May supervise Supplier Quality Engineers We are committed to promoting diversity in the workplace and embrace our responsibility to equal employment opportunities for all qualified individuals and are committed to providing accessibility to employment opportunities for individuals with disabilities. If you need technical assistance with the online application process, please call (650) 903-1000. ****************************************************************** For the opportunity below, please send resume to wd_darshana at hotmail dot com. Machine Learning Specialist - SF, CA Other opportunities are posted in JOBS category at the link below. darshanavnadkarni.wordpress.com Machine Learning Specialist - SF, CA Requirements: Minimum 5 years experience in creating high-performance classifiers,

3/17/2013 10

preferably working on biological data. Deep knowledge, skills and experience in machine learning techniques, in particular for processing large databases of biological information. Should be proficient and able to design, operate and validate intelligent systems from scratch. Excellent written, verbal and teamwork skills. Highly preferred: Relevant bio experience, such as working with biological signal databases; Experience in engineering for consumer devices/services; and Python expertise. Responsibilities: Lead the development of algorithms based on the signals from our advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into our consumer products. ******************************************************** https://jobs.smartbrief.com/action/listing?listingid=301FF649-3812-4CDC-A0EE-223AB40A20F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 REGULATORY AFFAIRS SPECIALIST Masimo Corporation Job Description Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion. To learn more about us, please visit: www.masimo.com Job Summary: In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations. From coordinating with international regulatory team members on product changes to maintaining up-to-date information on domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent’s medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people’s lives. Duties & Responsibilities:

Support the regulatory team managing international and domestic filings/registrations; Coordinate with international regulatory team members on product changes and

regulatory notification / approval requirements; Assist in maintaining product list on Certificate of Foreign Government; Maintain up-to-date knowledge on international and domestic regulatory requirements;

3/17/2013 11

Generate and maintain product compliance checklists; Provide regulatory support to the OEM Deployment group; Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports; Submit document change orders (DRO/agile) for approvals; As requested by supervisor, represent RA department in project meetings and provide

regulatory guidance;

Update RA responsible quality system procedures as required (SQP/SOP’s); Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience: Minimum Qualifications: Computer Proficiency with MS Office (Word/Excel/Access/Outlook);

Excellent verbal and written communication skills; Excellent prioritizing, organizational, and interpersonal skills; Excellent documentation skills including record maintenance/tracking and understand

document traceability; A detail-oriented individual with a “can do” attitude; Ability to work in a team environment as well as individually with minimal supervision; Ability to work in a fast-paced , Project Team environment, with multiple

tasks/projects; Preferred Qualifications:

Some previous work experience in a medical device Class II/ III environment; Experience in patient monitor systems, hospital-based products, software or electronic

device products; Knowledge of regulatory submission requirements for FDA Class II medical devices, and

equivalent classification requirements for international submission; Experience with FDA/GMP requirements for medical device; Experience in Quality Systems, per ISO 13485;

Experience with the UL/ETL certification process;

Experience interacting with regulatory bodies, such as the Notified Body; Education: High School or GED is required. Some college level coursework is preferred. BA/BS Degree is a definite plus. Physical requirements/Work Environment This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local

3/17/2013 12

travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described. Masimo is proud to be an EOE, M/F/D/V, and we value and are committed to Diversity at every level. ********************************************************

http://bull.hn/l/12DW5/4

Contact me today about a Senior Clinical Data Manager opportunity in the South San Francisco, CA area! [email protected]

Now Hiring: Senior Clinical Data Manager in South San Francisco, CA Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have a contract opportunity for a Clinical Data Manager for our client in South San Francisco, CA. The Clinical Data Manager will act as a core member of Study Management Teams and serve as the study data management contact at the study and/or program level, providing expert guidance to program teams. RESPONSIBILITIES: - Leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies -Interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met -Provides early strategic input into protocol design focused on data management issues -Leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives -Oversees all data review and cleaning activities involving close interaction with project clinical research professionals -Implements standards within Study Data Management across one or more CDM study teams -Develops and executes ad hoc database queries utilizing data review and query tools -Manages projects resourced externally via contract research organizations or corporate partners SKILLS: -Knowledge of core clinical data management applications Clinical data management systems, electronic data capture, query tools, web browser, MS Office suite -Clinical data management system experience EDC Medidata Rave preferred -Ability to apply advanced principles, theories and concepts for CDM as a whole -Understanding of the conceptual basis for data management conventions, standards and processes -Good understanding of the role of data management, biostatistics and statistical programming in the drug development process -Ability to develop solutions to complex problem -Ability to multi-task and effectively set own priorities -Strong organizational skills -Strong communication and interpersonal skills

3/17/2013 13

EDUCATION/EXPERIENCE: - B.A./B.S. or equivalent -Minimum of 5 years experience in Clinical Data Management If you meet the qualifications and requirements for this position, please Apply Now. Qualified candidates will be contacted.

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

Dermatopathology Rep - Los Angeles

Now hiring: Dermatopathology Rep - Los Angeles http://www.ziprecruiter.com/job/Dermatopathology-Rep-Los-Angeles/3b8ddba7/?source=social-linkedin-group-jobs

******************************************************** Senior) Clinical QA Specialist – Contract or 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 [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: The Clinical QA Specialist supports the Clinical Quality Assurance (CQA) management in developing its clinical quality systems and procedures. Assists in development of audit plans to ensure all trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements. Assists with CQA audits of clinical sites, quality systems, clinical vendors and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements. Assists with audit reports management and corrective action plan completion. Ensures work is carried out according to GCP standards as defined in the ICH Guidelines, corporate policies and procedures, and all regulatory requirements. Assists with development of CQA plans and implementation of the actions necessary to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirement. Assists with conducting US and international sites, internal and external clinical systems and clinical vendor audits. Assists with all audits are followed-up and corrective actions are completed, implemented, and verified. Assists with investigations of GCP-related matters (i.e., product complaints). Assists with CQA quality systems and supports department infrastructure development; assist with creation/revision of appropriate CQA SOPs. Assists with GCP training activities. Assists in the review of regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (Protocol, Informed Consent Form, and Trial Master Files). Assists in the development of metric reports to CQA management of all issues related to the outcome of the audits. Facilitates CQA team meetings and discussions as needed. EXPERIENCE AND QUALIFICATIONS: Minimum BA/BS Degree in biological sciences, chemistry, or related field. 3+ years of pharmaceutical experience in a clinical development arena.

3/17/2013 14

1+ year direct US and international Clinical QA auditing experience. Must be a team player. Excellent working knowledge and understanding of GCP-related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong clinical development background. Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem solving skills. Ability to work effectively in a fast-paced environment with initiative and great organization skills. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e., Microsoft Office products). Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com ******************************************************** Apply on company website If you wish to apply, simply click the ‘Apply’ button and fill out the form or email your resume to: [email protected] (no PDFs please) Senior Regulatory Affairs / RA Specialist Sterling Life Sciences- California (San Francisco Bay Area) Job Description See below for a job description / partial list of responsibilities. JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Develop submissions for domestic US clearances 2) Work with various project teams and provide regulatory support to assigned teams as needed 3) Ensure for management of preparation and maintenance of US regulatory submissions and other pre-market filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner 4) Determine and document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with regulatory management as needed 5) Control and maintain regulatory records 6) Represent regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions 7) Confer with other departments about the regulatory requirements of new product designs and changes to existing designs 8) Review and approve new documents and product changes for compliance and to determine if a new premarket application is required 9) Assist engineering in maintenance of design history files and related records on an as needed basis and where regulatory responsibilities permit 10) Review technical publications, articles and abstracts to stay abreast of regulatory and technical developments in the industry More questions? Want to know the Salary range? Keep reading.

3/17/2013 15

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. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-89905 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).

3/17/2013 16

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: [email protected] Additional Information Posted:March 13, 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:11171189905 Job ID:5101369 __________________________________________ Apply on company website Senior Regulatory Affairs / RA Specialist 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: [email protected] (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Develop submissions for domestic US clearances 2) Work with various project teams and provide regulatory support to assigned teams as needed 3) Ensure for management of preparation and maintenance of US regulatory submissions and other pre-market filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner 4) Determine and document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with regulatory management as needed 5) Control and maintain regulatory records 6) Represent regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions 7) Confer with other departments about the regulatory requirements of new product designs and changes to existing designs 8) Review and approve new documents and product changes for compliance and to determine if a new premarket application is required 9) Assist engineering in maintenance of design history files and related records on an as needed basis and where regulatory responsibilities permit 10) Review technical publications, articles and abstracts to stay abreast of regulatory and technical developments in the industry More questions? Want to know the Salary range? Keep reading.

3/17/2013 17

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. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-89905 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

3/17/2013 18

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: [email protected] Additional Information Posted:March 13, 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:11171189905 Job ID:5101369 _______________________________________________________ QC Manager ( Quality / QA ) 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: [email protected] (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Establish Key Performance Indicators (KPI) and Quality Performance Indicators (QPI) for site quality and compliance operations 2) Manage the effective operation of the document control system and maintenance of the relevant records 3) Ensure effective external and internal audit programs and determine compliance with regulations 4) Manage document for all company documentation (policies, procedures and controlled forms) including document change requests, notifications of new documents mastered 5) Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality 6) Conduct root-cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process 7) Ensure company and products are compliant with applicable regulations and laws 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

3/17/2013 19

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. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Quality-California-Biotechnology-Jobs-Careers-89336 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.

3/17/2013 20

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: [email protected] Additional Information Posted:March 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Quality Assurance, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11170189336 Job ID:5087427 ___________________________________________________ Apply on company website QC Manager ( Quality / QA ) 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: [email protected] (no PDFs please) JOB DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES) ============================================== 1) Establish Key Performance Indicators (KPI) and Quality Performance Indicators (QPI) for site quality and compliance operations 2) Manage the effective operation of the document control system and maintenance of the relevant records 3) Ensure effective external and internal audit programs and determine compliance with regulations 4) Manage document for all company documentation (policies, procedures and controlled forms) including document change requests, notifications of new documents mastered 5) Participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality 6) Conduct root-cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process 7) Ensure company and products are compliant with applicable regulations and laws 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

3/17/2013 21

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. Another Tip: Don't worry about whether you are ‘qualified’ or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right? Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win – because you've improved your visibility with one of the most prestigious recruiting firms in the country! Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will. Here is the link to the job description again: http://www.mybiotechcareer.com/JD/Quality-California-Biotechnology-Jobs-Careers-89336 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.

3/17/2013 22

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: [email protected] Additional Information Posted:March 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Quality Assurance, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11170189336 Job ID:5087427 ******************************************************** Controller Alexza Pharmaceuticals- San Francisco Bay Area Job Description We have an exciting opportunity for a Controller on our team. This person will work closely with our Finance staff to transition our organization to commercial readiness. Responsible for the controller function in an independent corporation on a global, regional or country basis. Directs the accounting function, maintains fiscal records, establishes and maintains budgetary controls and procedures and prepares financial reports. Responsibilities: • Develop, interpret, prepare and administer the company policies, procedures and plans relating to all accounting and reporting matters, including revenue recognition and share-based compensation. • Manage the accounting systems, including the general ledger, accounts payable, accounts receivables, fixed assets and payroll. • Collaborate with the Executive Director, Finance and Manager, Cost Accounting in the areas of cost and inventory accounting. • Maintain and develop internal control structure including development and revision of accounting policies and procedures. • Lead the annual financial audits and quarterly financial reviews with the independent auditors. • Prepare and file the Form 10Qs and 10Ks, Proxies and annual reports • Work with our outside counsel to ensure we comply with all SEC reporting requirements (Form 8-Ks, Section 16, etc). • Manage the Sarbanes Oxley 404 compliance program. • Research accounting issues and prepare memorandums for management, the Audit and Ethics Committee and the independent auditors • Supervise, develop and train members of the accounting staff • Function as the Company’s stock administrator, including stock options, restricted stock units, share-based compensation, etc. • Manage governmental grant processes.

3/17/2013 23

• Assess and implement appropriate accounting and project systems. • Manage tax reporting and the tax return filing processes. • Review contracts for accounting implications. • Lead the annual 401K plan audits and compliance activities. • Manage relationships with various vendors such as the: auditors, transfer agent, outside counsel, etc. Desired Skills & Experience Skills required: • Excellent communication skills, both written and oral. • Ability to interface effectively with senior management, board members/audit committee and other internal/external contacts. • Strong attention to detail and confidentiality. • Ability to manage financials for multiple products/programs. • Advanced MS experience including Excel, Word, PowerPoint, and financial software programs. • Ability to work in a fast paced environment. Education and experience: • Bachelor’s Degree, CPA, 10-12 years of experience, with at least 2 years manager level experience at a Big 4 accounting firm • Strong knowledge of GAAP and ability to advise on technical accounting issues • Background with life science companies and government grants a plus We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. Alexza Pharmaceuticals is an Equal Opportunity Employer. Direct Applicants only - NO AGENCIES, PLEASE. Company Description Alexza Pharmaceuticals, located in Mountain View, CA, uses our proprietary Staccato technology to develop CNS products to enhance patient treatment. The Staccato technology provides for the rapid but non-invasive delivery of drugs to treat acute conditions. Our products address unmet medical needs not currently addressed, for example, by either oral medications or injections. We recently received FDA approval of our first product, ADASUVE. You can read more about ADASUVE at www.adasuve.com. ADASUVE has received regulatory approval in the US and our application is pending final approval for Europe. As you can see, our approach is simple but elegant. We combine the proven Staccato delivery technology with known drugs that currently lack an optimal mode of delivery. Alexza hopes to write a new chapter in the ever advancing field of patient treatment. Alexza was founded by Alejandro Zaffaroni, a pioneer and visionary in the field of drug delivery. Through the years, Alexza has strived to maintain both the entrepreneurial spirit and very high standards set by Dr. Zaffaroni. Alexza has great technology and great people who are doing great things. Every individual in the company plays a critical role in Alexza’s success. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance, Accounting/Auditing Industries:Pharmaceuticals, Medical Devices, Biotechnology Job ID:4950549 ********************************************************

3/17/2013 24

Apply on company website VP | Sr Director Marketing - Early Stage Big Data Start Up Concurrent Inc.- San Francisco HQ (San Francisco Bay Area) Job Description Reporting to the CEO, the VP Marketing is responsible for WW Marketing, including corporate, field, product, online and customer marketing. This position is responsible for planning, organizing, staffing, training and managing all marketing functions to achieve Concurrent’s objectives of user adoption and sales growth while ensuring a marketing message and position consistent with corporate direction. Key Responsibilities:

Create and manage marketing campaigns to increase leads, opportunities, and upsell to existing customers

Promote campaigns and activities that increase web presence, visitor traffic, and lead generation

Understand, track and improve upon key marketing metrics Proactively identify, develop and drive longer-term marketing and communications

strategies and initiatives that will result in increased visibility and profitable growth Produce in-depth market assessment, sales information and customer retention data to

define gaps in business strategy and develop recommendations for action based on sound analysis

Develop the company’s marketing communications and brand strategy, and work with the Executive Team to establish corporate messaging and positioning

Convert business ideas and research into actionable product releases with an emphasis on revenue and performance

Work in close conjunction with the Sales organization and own the key messaging points around value proposition and differentiation, including the needs of different regions

Work closely with Product Development and Product Management to assist in prioritizing strategic direction and feature/product priorities

Speak externally to analysts, customers and trade journalists Achieve market share by developing and establishing promotional strategies; implementing advertising

Accomplish staff results by communicating job expectations, planning, monitoring, and appraising job results, coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies and procedures; ensure that staff morale is positive to meet the sales organization's commitments

Desired Skills & Experience Experience leading a Marketing department in Enterprise Software Experience with marketing open source technologies and or freemium product offerings

is a big plus Experience with building and nurturing developer communities Minimum 10 years of experience in progressive Marketing roles at the senior

management level Must possess key competencies including strategic vision and analytical skills enhanced

by intuitive consumer insights Must have entrepreneurial and innovative DNA, willing to consider the outrageous and

respect the pragmatic Must have deep understanding of social media, viral marketing, the Internet and the

strategic marketing opportunities they represent Must be a team player and believe in the value of inclusion and collaboration Must be comfortable with the high growth/small company dynamic of rolling up your

sleeves and doing whatever it takes to get the job done given the constraints of time, budget and human resources

3/17/2013 25

Strong leadership and motivational skills, responsive and flexible Ability to think strategically one minute and execute tactical details the next Focused on flawless execution Extremely resourceful, highly creative and high energy, able to brainstorm and

implement new ideas Demonstrated analytical, problem solving and decision-making abilities Ability to persuade and positively influence at all levels of the organization Ability to handle multiple projects in a fast-paced environment

Our ideal candidate would have all of the above; however, if you feel that your combination of skills, education, and experience positions you as a good fit, we'd love to hear from you. Company Description Concurrent is one of the hottest early stage Enterprise Big Data startups. Founded in 2008, Concurrent simplifies Big Data application development, deployment and management on Apache Hadoop. We are the company behind Cascading, the most widely used and deployed technology for building Big Data applications with more than 75,000 user downloads a month. Enterprises including Twitter, eBay, The Climate Corp and Etsy all rely on Concurrent’s technology to drive their Big Data deployments. Concurrent is funded by Rembrandt Venture Partners and True Ventures and is headquartered in San Francisco. Web - http://concurrentinc.com. Case Studies - http://concurrentinc.com/casestudies. Additional Information Posted:February 16, 2013 Type:Full-time Experience:Executive Functions:Marketing Industries:Computer Software Compensation:Competitive, Stock Options Job ID:4896527 ******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5012906&trk=rj_em&ut=0h3l9OxVa9N5E1 Sr Marketing Product Manager NCompass Recruiting Services- San Francisco Bay Area Job Description Sr Marketing Product Manager Summary: Accountable for 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.

3/17/2013 26

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. Build an identity and establish effective positioning, working closely with Marketing

Directors, Marketing Communications, Clinical Field Specialists, Sales Directors and Sales Training Staff.

Desired Skills & Experience Medical Device Marketing experience in the cardiovascular space is highly preferred. 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 ServicesAdditional Information Posted:March 4, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Medical Devices Job ID:5012906 ******************************************************** https://jobs.smartbrief.com/action/listing?listingid=4924B304-3585-430F-B029-AEAE1A2410F4&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Compliance Consultant 2 DJO Global Job Description

3/17/2013 27

DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Compliance Consultant 2at our Corporate Headquarters in Vista, CA. JOB DETAILS • Responsible for researching, monitoring and executing compliance tasks of intermediate scope, complexity and risk. • Participates in and provides compliance support for projects and initiatives with moderate risk to identify, assess and mitigate compliance risk in business activities. • Develops and implements testing methodologies to evaluate the effectiveness of compliance policies, procedures and processes. • Identifies, documents and reports findings and issues to compliance management. • Creates corrective action plans, communicates and manages the change to ensure compliance with federal, state, agency, legal, regulatory and internal requirements. • Works on special projects and audits as assigned EDUCATION & EXPERIENCE • Bachelors Degree required. • Minimum of 3 years of experience in compliance. • Knowledge of AdvaMed (or PhRMA) Code of Ethics preferred. • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. • Ability to be interactive with executives and other senior level personnel. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Computer skills: Excel, Visio, Word, Access. ABOUT DJO GLOBAL DJO Global is headquartered in San Diego, CA (Vista). The Company's products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company's medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Our product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare® and DJO® Surgical. DJO is a portfolio company of the Blackstone Group. EEO/AA-M/F/VET/HANDICAP ******************************************************** Posted by Harry Wachob, President & Founder of The Bio2Device Group Please give me a call (916) 835-1004 or send me an email regarding any of these roles. Send me your resume too. Greg Grichuhin Senior Recruiter Med Device Search Group

3/17/2013 28

(916) 835 1004 [email protected] multiple opportunities Senior Manufacturing Engineer - San Francisco (CA) Company manufactures novel vascular devices. Need a Senior Manufacturing Engineer. Create and modify Processes. Small company environment. 300 employees and one location. This company is growing and exciting to work for. Polymer Scientist - Mountain View (CA) Company manufacturers vascular plug (PEG) to close femoral artery after surgery. Need an Engineer with knowledge of medical device polymers. Looking for someone who can develop new formulations AND help with manufacturing / process manufacturing. This is more of an Engineering role than a Scientist position. Staff R&D Engineer - Irvine (CA) Company manufacturers RF Ablation devices for heart procedures. The global organization has jobs open superstar candidates. Must have ME and have done at least one catheter based project from concept to commercialization. Senior Development Engineer - Mountain View (CA) Company makes catheter components and medical device tubing. Rapidly growing group. Heat shrink tubing and extrusions. Project R&D Engineer - Salt Lake City (UT) Company makes electrosurgial products for cutting and cauterizing tissue. The role is designing Arthroscopic instruments. Past instrument design experience with laparoscopic needed here. ******************************************************** Apply on company website Financial Planning Manager Allergan- Orange County, CA (Orange County, California Area) Job Description Reporting to the Director of Finance – R&D, the Financial Planning Manager is responsible for integrity of operating expenses and preparation of Global R&D organizational reports encompassing all constituents of R&D – Pharma R&D, Medical Device R&D, Regulatory Affairs, Phase IIIB, International Projects and Medical Affairs. Be responsible for Accounting and Financial Planning management for R&D. GL accounting oversight and reconciliation (P&L, Balance sheet accounts). In licensed deal and acquisition support. Preparation of Global R&D reporting encompassing all constituents of R&D – Pharma R&D, Medical Device R&D, Regulatory Affairs, Phase IIIB, International Projects and Medical Affairs. Proficient use of enterprise accounting and reporting systems (SAP BW, EPM). Global R&D Capital (Equipment and Facilities) support. Prepare Capital Strategic plan and forecasts. Representative for Global R&D needs and issues. Global facility overview and support – leasehold improvement projects, lab/vivarium changes etc. Interact with Allergan senior R&D and Corporate Engineering management and building landlords. Support the budgeting and forecasting processes for Discovery outside costs and departmental expenses, as well as analysis of variances. Work with executive leaders in Discovery to help manage financial performance. Actively participate in the data collection, review and consolidation of clinical study cost drivers to generate realistic, achievable study budgets. Using available system technologies (Cleartrial, SAP/BW), prepare appropriate analyses and reports for use by R&D Management. Act as finance liaison for select clinical study teams. Provide support and training to R&D personnel to ensure accounting and finance policies and procedures are understood. Ad hoc projects. Desired Skills & Experience

3/17/2013 29

Degree with emphasis in Finance, Accounting or Business Administration; MBA / CPA / CMA preferred. Current knowledge of finance and accounting practices and theories as they apply to broad cross-functional business decisions and plans. This level of knowledge would normally be acquired through at least five additional years of finance / accounting experience, preferably in a Fortune 500 company. 5-10 years financial planning experience preferably gained in the pharmaceutical industry. Excellent planning, organization and time / resource management skills, analytical and communication skills. Strong personal computer and systems skills, primarily in the areas of financial spreadsheets, modeling and database management, as well as presentation formats. Proficiency with SAP, Business Warehouse (BW) and Enterprise Performance Management (EPM) is preferred. Strong interpersonal skills, with an effective ability to influence others. Able to weigh costs / benefits. Proactively seeks out ways to add value / reduce work. Ability to work independently, with minimal supervision, under tight deadlines. Ability to function as an effective team member. High level of intellectual curiosity and flexibility. Company Description Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 10,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work. Additional Information Posted:March 15, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Pharmaceuticals, Biotechnology, Financial Services Job ID:5130558 ******************************************************* Apply on company website Payroll and Benefits Administration Manager Pharmacyclics- San Francisco Bay Area Job Description The Payroll and Benefits Manager will implement, manage and administer all payroll and benefits programs. The individual will have direct responsibility for payroll processing, benefits administration, Federal and State compliance, public company/sox compliance, service reporting, cost management, and relationship management. PAYROLL

Ensure accurate calculation of wages, tax withholdings and company deductions. Perform accounting/general ledger functions as it relates to payroll and compensation,

i.e. balance sheet account analyses, journal entries, accruals and other month end close functions.

3/17/2013 30

Identify and resolve discrepancies between payroll interface and the General Ledger. Work closely with Financial Planning & Analysis to produce compensation reports used

for the annual budget process . Deposit withholding taxes, file quarterly payroll tax reports, and manage W2 year end

process. Generate and respond to inquiries regarding paychecks. Processes bi-weekly payroll for US . Responsible for various payroll production processes (e.g. process new hires,

terminations, employee equity transactions, computing and processing time sheet data, pay rate changes, etc.).

Work with employees, internal departments (Finance, Accounting, HR, for example) and outside vendor companies to resolve problems and correct errors.

Respond to request for employment/salary verifications to the requesting organizations (mortgage companies, Federal/State agencies, etc.) according to established Company procedures .

Monitor changes in payroll tax laws to ensure compliance. Automate and streamline current processes when appropriate.

BENEFITS - Implement, manage and administer all employee benefit programs, including, but not limited to, medical, dental, vision, life, disability, COBRA, 401(k), Stock Options, ESPP, LOAs (FMLA, disability, personal, etc.), unemployment insurance, Workers’ Compensation, vacation and sick time, Flexible Spending Accounts (Section 125), etc.

Evaluate and compare existing employee benefits with the current market place and make specific recommendations.

Manage annual benefits renewal and conduct open enrollment (prepare materials and present benefit plan changes to employees).

Evaluate quality and usage of benefit programs. Research alternate benefit designs and deliveries. Conduct periodic financial analysis of benefit plans.

Plan, manage and conduct RFP process annually and as needed. Answer and/or research specific employee benefit questions. Investigate and resolve

discrepancies/issues working with employees, carriers and broker of record. Manage and process 401(K) plan administration, deferrals, loans and distributions

according to federal regulations and established Company procedures. Review, update and administer Company benefit programs and ensure compliance with

federal and state labor laws. Ensure legal compliance of all plans including timely and accurate ERISA and DOL filings such as 5500.

Work with EH&S team to accurately and timely report workers’ compensation claims; manage claims process efficiently; provide guidance to employees in returning to work.

Identify and resolve information system issues affecting benefits administration. Provide all required information to relevant department members and administer

benefits for new employees, current employees and terminating employees. Process timely enrollment/termination of employees in benefit plans and perform status

changes. Administer COBRA and LOA benefits timely and completely, ensuring all deadlines for

required notices are met. Coordinate stock option grants and ESPP enrollments. Plan and deliver education and wellness events (health fair, retirement seminars, etc.) Review and reconcile benefit related invoices for accuracy and process for payment. Maintain and upkeep required files following regulatory requirements.

Desired Skills & Experience Bachelor’s degree plus 5-10 years experience in a payroll and benefits role with

thorough knowledge of benefits and payroll principles. Prior experience as a Manager or Sr. Payroll & Benefits Administrator for a multistate,

publicly traded company.

3/17/2013 31

Experience with ADP HRIS and Payroll modules (HRB, Payroll, EZLabor, etc.) required. Certified Payroll Professional (CPP) certification or equivalent, required. In-depth knowledge in various areas of payroll (e.g. multi-state tax jurisdictions, equity

transactions, hypothetical tax issues, relocation, payroll systems, etc.), reporting and privacy issues.

Proven experience building, developing, and maintaining Payroll and Benefits policies and practices to support expansion and growth.

Experience with benefits administration, renewal negotiation, and open enrollment. Demonstrated knowledge of benefits programs, audits, filings (5500 and scheduled),

practices and related applicable laws. Strong computer skills in Microsoft Word, Excel, PowerPoint, and Outlook. Experience working in a fast-paced team environment handling multiple priorities and

tasks with professionalism, accuracy and efficiency. Demonstrated prior success in providing excellent customer service to all levels of the

company’s workforce. Ability to establish trust and confidence by maintaining a high level of credibility,

integrity, and excellent verbal and written communication skills. Ability to interface effectively with all levels of the organization. Ability to handle confidential and sensitive information appropriately. Effective conflict management, negotiation and time management skills.

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:March 16, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Biotechnology Job ID:5130791 ****************************************************** Posted by Amanda Rosales, Recruiter at SMR Group Ltd Email resume to [email protected] Looking for specialty pharma reps w/ demonstrable over quota sales success in Fargo-Grand Forks-Bismarck, ND, Albany, GA, Lima, OH, Phoenix, AZ, Tucson, AZ, San Francisco, CA, Cincinnati, OH. ____________________________________________________________ Looking for specialty pharma reps w/ demonstrable over quota sales success in Denver, CO, El-Paso-Albuquerque, TX-NM, Morristown, NJ, Boise, ID, San Jose, CA, Hempstead-Melville, NY. ****************************************************** Posted by Harry Wachob, President & Founder of The Bio2Device Group

3/17/2013 32

Connie Milburn [email protected] Marketing Assistant (or even an Associate Product Manager) One of my clients is looking for a Marketing Assistant (or even an Associate Product Manager). If you know of anyone searching for a new opportunity, I would love to meet them! ***************************************************** Apply on company website Payroll Specialist ZELTIQ- San Francisco Bay Area Job Description Reports To: Manager of Payroll, Compensation and Benefits Department: Human Resources FLSA: Non-Exempt Date: March 1, 2013 Summary: Process payroll for the company’s global employees. Track all accrued holiday/PTO and time taken on a domestic and international basis. Reconcile flexible spending and other benefit plans against payroll on a regular basis, as required. Reconcile state withholding taxes as required. Duties and Responsibilities include the following (other duties may be assigned.): The Payroll Specialist has primary responsibilities for ensuring that the Company’s payroll is processed accurately, timely and in compliance with the Company’s processes and controls. This includes:

Process Payroll for all Company employees, both domestic and international (presently U.S. and 7 countries in EMEA and APAC)

Ensure the appropriate calculation of all overtime for the Company’s non-exempt employees

Process any bonuses, sales commissions, and other earnings as necessary. Ensure appropriate approvals of all PTO requests through the Payroll system Assist in preparing month-end payroll journal entries. Reconcile payroll, PTO, flexible spending, and any other payroll related GL accounts. Investigate inquiries from taxing agencies (e.g. state tax departments, unemployment

insurance departments, etc.). Maintain appropriate controls, including verifying HR changes to the payroll system,

comparing roster of employees to pay register, etc. Desired Skills & Experience Qualifications:

This position requires a minimum of an Associate’s degree (A.A. or A.S.) or equivalent experience. Bachelor’s degree (B.A. or B.S.), or equivalent experience is preferred.

Requires 3-5 years experience working in a payroll position in a mid-size company environment.

Ability to work with salary and other confidential employee information in an appropriate manner

Must have experience using an automated Payroll system for purposes of Payroll processing, reporting, approval and processing

Must have experience with international payroll, preferably Europe, Canada and/or Asia Moderate PC skills, especially Excel, Word, and Microsoft Outlook. Organized, detail oriented, and responsible. Ability to communicate effectively, orally and in writing, with all levels of employees. Ability to use word processing and database applications, and various software

programs such as Excel and PowerPoint. Company Description

3/17/2013 33

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:March 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Human Resources, Finance Industries:Medical Devices, Health, Wellness and Fitness Job ID:5119859 *************************************************** Apply on company website Corporate Trainer Pharmacyclics- Sunnyvale, CA (San Francisco Bay Area) Job Description The Corporate Trainer will work as part of a team that delivers training in a number of formats to Pharmacyclics employees worldwide. Key Accountabilities/Core Job Responsibilities:

Identify and assess the training needs among Pharmacyclics employees and managers. Communicate with a variety of people including Pharmacyclics management. Coordinate training schedules with the customer and understand training demands. Establish the Training Institute within the organization Maintain positive relationships with all Pharmacyclics personnel and management. Keeps management informed of all area activities and of any significant client or

personnel problems. Demonstrate initiative by constantly looking for and recommending ways to improve

Pharmacyclics operations and/or customer service. Attends and participates in meetings as required. Develop, organize, conduct and evaluate training programs. Formulate training outline and determine instructional methods such as individual and

group training. Design or Facilitate training courses through online or onsite training sessions. Select or develop training aids such as training handouts, multimedia visual aids,

computer tutorials, and reference guides. Assist employees and managers with usage concerning “how to” perform specific tasks

related to Pharmacyclics. Develop strong relationship with all customers to develop course materials and receive

feedback. Help develop Pharmacyclics training material for new-hire internal training. Create teaching materials including training plans, handouts and visual materials. Amend and revise materials and/or training programs as necessary in order to adapt to

changes that occur. Facilitate the execution of all training plans including business and technical training for

new hires and/or current employees Train other trainers as the organization grows Plan, organize and implement a range of training activities. Present information using a variety of instructional techniques and formats such as role

playing, simulations, team exercises, group discussions, videos and lectures.

3/17/2013 34

Evaluate training effectiveness. Ensure all employees without fail have a training plan, that covers their basic corporate

training and on the job training according to their career path. Oversee all training schedules and ensure regular training is maintained. Maintain

training attendance records and report those back to management. Maintain training records.

Keep all up-to-date course material on file in online version of courses as applicable. Act as a supportive resource fielding questions about a variety of training topics. Act as a role model for all Pharmacyclics employees. Continuously increase knowledge in particular field and training by reading books,

journals and articles and attending meetings and training events. Adhere to all policies of Pharmacyclics including those outlined in the Pharmacyclics

Employee Handbook. Handle related tasks as assigned. Desired Skills & Experience BA/BS in Communications, Education, or Business

5-7 years training experience in a corporate environment delivering technical training and programs.

Previous training experience in the bio/pharmaceutical industry highly desirable. Well-versed in Windows and Mac and desktop software applications. Experience presenting to large audiences from all backgrounds. Demonstrated record of strong customer-facing skills and ability to build and sustain

ongoing customer relationships; ability to practice excellent customer service skills in a fast-paced environment.

Ability to present in front of a group, strong presence. Demonstrated ability to work within and team or independently with a high degree of

personal initiative and self-motivation. Ability to properly track and communicate problems, resolutions, and action items to

the customers and managers. 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:March 14, 2013 Type:Full-time Experience: Mid-Senior level Functions:Human Resources Industries:Biotechnology Job ID:5118392 ___________________________________________________ Apply on company website Payroll and Benefits Administration Manager Pharmacyclics- San Francisco Bay Area

3/17/2013 35

Job Description The Payroll and Benefits Manager will implement, manage and administer all payroll and benefits programs. The individual will have direct responsibility for payroll processing, benefits administration, Federal and State compliance, public company/sox compliance, service reporting, cost management, and relationship management. PAYROLL

Ensure accurate calculation of wages, tax withholdings and company deductions. Perform accounting/general ledger functions as it relates to payroll and compensation,

i.e. balance sheet account analyses, journal entries, accruals and other month end close functions.

Identify and resolve discrepancies between payroll interface and the General Ledger. Work closely with Financial Planning & Analysis to produce compensation reports used

for the annual budget process . Deposit withholding taxes, file quarterly payroll tax reports, and manage W2 year end

process. Generate and respond to inquiries regarding paychecks. Processes bi-weekly payroll for US . Responsible for various payroll production processes (e.g. process new hires,

terminations, employee equity transactions, computing and processing time sheet data, pay rate changes, etc.).

Work with employees, internal departments (Finance, Accounting, HR, for example) and outside vendor companies to resolve problems and correct errors.

Respond to request for employment/salary verifications to the requesting organizations (mortgage companies, Federal/State agencies, etc.) according to established Company procedures .

Monitor changes in payroll tax laws to ensure compliance. Automate and streamline current processes when appropriate.

BENEFITS - Implement, manage and administer all employee benefit programs, including, but not limited to, medical, dental, vision, life, disability, COBRA, 401(k), Stock Options, ESPP, LOAs (FMLA, disability, personal, etc.), unemployment insurance, Workers’ Compensation, vacation and sick time, Flexible Spending Accounts (Section 125), etc.

Evaluate and compare existing employee benefits with the current market place and make specific recommendations.

Manage annual benefits renewal and conduct open enrollment (prepare materials and present benefit plan changes to employees).

Evaluate quality and usage of benefit programs. Research alternate benefit designs and deliveries. Conduct periodic financial analysis of benefit plans.

Plan, manage and conduct RFP process annually and as needed. Answer and/or research specific employee benefit questions. Investigate and resolve

discrepancies/issues working with employees, carriers and broker of record. Manage and process 401(K) plan administration, deferrals, loans and distributions

according to federal regulations and established Company procedures. Review, update and administer Company benefit programs and ensure compliance with

federal and state labor laws. Ensure legal compliance of all plans including timely and accurate ERISA and DOL filings such as 5500.

Work with EH&S team to accurately and timely report workers’ compensation claims; manage claims process efficiently; provide guidance to employees in returning to work.

Identify and resolve information system issues affecting benefits administration. Provide all required information to relevant department members and administer

benefits for new employees, current employees and terminating employees. Process timely enrollment/termination of employees in benefit plans and perform status

changes.

3/17/2013 36

Administer COBRA and LOA benefits timely and completely, ensuring all deadlines for required notices are met.

Coordinate stock option grants and ESPP enrollments. Plan and deliver education and wellness events (health fair, retirement seminars, etc.) Review and reconcile benefit related invoices for accuracy and process for payment. Maintain and upkeep required files following regulatory requirements.

Desired Skills & Experience Bachelor’s degree plus 5-10 years experience in a payroll and benefits role with

thorough knowledge of benefits and payroll principles. Prior experience as a Manager or Sr. Payroll & Benefits Administrator for a multistate,

publicly traded company. Experience with ADP HRIS and Payroll modules (HRB, Payroll, EZLabor, etc.) required. Certified Payroll Professional (CPP) certification or equivalent, required. In-depth knowledge in various areas of payroll (e.g. multi-state tax jurisdictions, equity

transactions, hypothetical tax issues, relocation, payroll systems, etc.), reporting and privacy issues.

Proven experience building, developing, and maintaining Payroll and Benefits policies and practices to support expansion and growth.

Experience with benefits administration, renewal negotiation, and open enrollment. Demonstrated knowledge of benefits programs, audits, filings (5500 and scheduled),

practices and related applicable laws. Strong computer skills in Microsoft Word, Excel, PowerPoint, and Outlook. Experience working in a fast-paced team environment handling multiple priorities and

tasks with professionalism, accuracy and efficiency. Demonstrated prior success in providing excellent customer service to all levels of the

company’s workforce. Ability to establish trust and confidence by maintaining a high level of credibility,

integrity, and excellent verbal and written communication skills. Ability to interface effectively with all levels of the organization. Ability to handle confidential and sensitive information appropriately. Effective conflict management, negotiation and time management skills.

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:March 16, 2013 Type:Full-time Experience:Mid-Senior level Functions:Finance Industries:Biotechnology Job ID:5130791 **************************************************** Marketing Product Manager - San Diego Miltenyi Biotec, Inc.- Greater San Diego Area

3/17/2013 37

Job Description Miltenyi Biotec Inc., a global leader in biological magnetic separation technologies, is seeking a Marketing Product Manager in San Diego, CA to perform strategic marketing functions for designated product areas supporting corporate direction, communicating new product launch and coordinating tactical marketing projects. Responsibilities: • Perform strategic market analysis: market size and drivers, segmentation analysis, competitive landscape, opportunities and factors for success, etc. • Develop and execute comprehensive marketing plans and programs, both short and long range, to support sales and revenue objectives • Develop pre-launch and launch plans for new products for US and Canada • Develop and implement “how to sell” guidelines for sales representatives, including product rationale, positioning, competitive overview, companion products, etc. • Coordinate and participate in strategic discussions/activities with counterparts in Germany • Monitor competitive products and marketing activities • Develop rolling sales forecasts for new and current products • Establish and maintain relationships with industry influencers, key opinion leaders and strategic partners Desired Skills & Experience Requirements: Bachelor’s or graduate degree in the life sciences, Ph.D. or MBA preferred. Candidates must have in-depth technical knowledge and 5 years of experience in Stem Cell or Immunology/Hematology research areas; or equivalent combination of education and industry experience. We offer a competitive salary and excellent benefits package. There is no relocation associated with this position. EOE/AA Company Description Miltenyi Biotec, founded in 1989, has grown to over 1100 employees in 18 countries. The company develops, manufactures, and sells more than 1000 products and services; particularly in the fields of cell biology, immunology, regenerative medicine, and molecular biology. Miltenyi Biotec developed MACS® Technology, the gold standard method in magnetic cell separation. The ease and speed of the procedure combined with high purity and yield are some of its many advantages. MACS Technology combines the use of MACS MicroBeads (nano-sized superparamagnetic particles coupled to specific antibodies), patented MACS Columns, and MACS Separators. MACS Technology offers a multitude of applications: from small-scale to large-scale cell purifications, from cell to biomolecule separations, from lab bench to clinical research applications and separation of adult stem cells – for example, with the CliniMACS® Cell Separation System. The MACSmolecular Business Unit develops, markets, and sells innovative products for molecular biology research and provides bioinformatics and gene expression profiling services, as well as the generation of transgenic disease models. The TheraSorb™Therapeutic Apheresis product division offers unique medical instruments, adsorbers, and tubing sets for therapeutic apheresis. The Miltenyi Bioprocess division manufactures custom biopharmaceuticals, cellular products, medical devices, and related products and services. Our R&D departments are constantly developing novel reagents and instruments for use in immunology, cell and molecular biology, bioinformatics, and stem cell technologies – researchers working for researchers. The technical expertise of the employees is vast. It spans biological and chemical disciplines, including immunology, cell and molecular biology, hematology, regenerative medicine, organic

3/17/2013 38

and inorganic chemistry through physics and engineering, including biomedical, electrical, plastics and software development. Additional Information Posted:March 14, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Biotechnology Job ID:5117331 **************************************************** Contact [email protected] if interested! Local candidates only will be considered at this time. If you are not local but plan to relocate, please let us know. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. Senior Quality Assurance Specialist BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Senior Quality Assurance Specialist to work for a leading Bay Area biotechnology company. Senior Quality Assurance Specialist Position Description: Perform as a senior level lead in a quality environment, implementing, documenting and auditing the company’s quality system and compliance. Ensure documentation and auditing are performed for quality system procedures Perform failure investigations and corrective actions Prepare, review, approve and improve documentation for manufacturing and quality control Schedule or perform maintenance and calibrations on equipment Ensure products meet R&D specifications and quality standards. Operate lab instruments and software for data collection and analysis Promote and oversee design control, verification, and product validation Preparation, review, approval and improvement of documentation for manufacturing and quality control Ability to participate in audits for regulatory and customers. Update existing documentation to new regulations/standards. Input QA incident reports to automated system. Requirements: Bachelor’s degree in Microbiology, Molecular Biology; or related life science discipline with microbiology experience Minimum 4 years of related experience in Microbiology or Molecular Biology with significant knowledge of quality control operations Experienced with cGMP and ISO Familiarity with the preparation of published documents such as Certificate of Analysis and MSDS’s.

3/17/2013 39

Computer experience with MS office and ERP systems. Excellent skills in communication and time management *****************************************************

Jobs That Crossed My Desk through March 7, 2013 *************************************************** Posted by Harry Wachob, President & Founder of The Bio2Device Group FYI--Software Engineer Curexo Technology Corp. Fremont, CA Llink at http://goo.gl/r59D4 The Company is a pioneer in medical robotics and world leader in image-directed, robotic products for orthopedic applications. The Company’s product allows surgeons to pre-operatively plan their surgery in a 3-D virtual space and then execute the surgery in the operating room, exactly as planned. JOB DESCRIPTION The software engineer designs, implements, and integrates software for the ROBODOC system. The ideal candidate will have extensive experience designing and implementing C++ applications for medical devices. In addition, the ideal candidate will have a working understanding of FDA and ISO standards. • Works with software engineering team to develop software for robotic surgical assistant. • Design and implement user interface and workflow for surgical procedure. • Integrate algorithms and modules designed by other groups. • Design, implement, and validate C++ applications. • Follow rigorous design control methodology and write concise requirements specifications, architecture specifications, and design description, verification plans, and test cases. • Performs unit testing of software and assists in the verification and validation process. • Manages schedules, meet and adhere to development goals. • Provides planning and status information to project manager. This position may require less than 5% travel. Requirements QUALIFICATIONS • Must have 5+ years of experience in software development and developing applications with C++. • Must have 3 years of experience with medical imaging. • Must have 3 years of experience with algorithms development • Must have 3 years of experience with image processing. • Must have a strong working knowledge of object-oriented programming and system design. • Experience with multithreaded and multi-process programming. • Experience developing test procedures and testing modules. • Familiarity with VTK and ITK desired, but not required. • Excellent communication and documentation skills. • Bachelor’s degree in computer science or related field. ADDITIONAL INFORMATION Curexo Technology Corporation offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits. ******************************************************* For more information and to apply please call or visit:

3/17/2013 40

http://jobs.cpspharm.com Phone (Toll Free): 877.806.7888, Ext:1238 - See more at: http://www.pharmacyweek.com/career/26640/Director-Pharmacy-California-Ca-Turlock#sthash.2Mm5ZY9S.dpuf DIRECTOR OF PHARMACY Emanuel Medical Center Turlock, CA DESCRIPTION As Director of Pharmacy with CPS you will have a full support team available to you. From a 340B Specialist, Regulatory Specialist, Drug Information Specialist, Operations specialists and more. We’ll rely on you to oversee all pharmacy operations including planning, organizing, controlling and supervising activities in the hospital pharmacy according to hospital policies, standards of practice of the profession, and State and Federal laws. PHARMACY The 24/7 Pharmacy is centralized with BMV and supported by Meditech and Omnicell. The Pharmacy is managed by Comprehensive Pharmacy Services (CPS). The Director of Pharmacy is an employee of CPS. All other pharmacy staff are employees of the hospital. FACILITY Emanuel Medical Center has been providing healthcare services to the community of Turlock since 1917. The current medical center includes a 206 bed acute care, not-for-profit community hospital, and offers state-of-the art services including emergency, critical care, birthing, pediatrics, cardiology, surgery, imaging, laboratory, rehabilitation, home health, hospice and community education. The hospital has a widely acclaimed cardiac surgery program and has just implemented a new Cancer Center. Emanuel Cancer Center is fully accredited by the American College of Surgeons’ Commission on Cancer in recognition of its stellar quality of treatment and care. Emanuel is owned by Evangelical Covenant Church. In addition to the acute care hospital, Emanuel also operates a 145 bed skilled nursing facility and a 49 bed assisted living facility. REWARDS CPS full-time employees enjoy a competitive salary and comprehensive benefits package, including Medical/Dental/Vision Insurance / 401(k) with a Match / Paid Time Off (PTO) including Paid Holidays / Company Paid Short and Long-Term Disability / Basic and Supplemental Life Insurance / Medical Flex and Dependent Care Accounts / Relocation / and More. QUALIFICATIONS

BS or PharmD degree from an accredited school of pharmacy California pharmacist licensure in good standing. Current or recent experience as a pharmacy leader in a hospital setting. Demonstrated ability to work independently, set priorities, make critical decisions,

respond to client concerns and work cooperatively with other members of Comprehensive Pharmacy Services and hospital and pharmacy staff.

ABOUT CPS CPS is a pharmacy management services provider for 350+ acute-care hospitals, long-term acute care, behavioral health systems, and specialty hospitals in 47 states, Puerto Rico and the Virgin Islands. For over 40 years we have delivered pharmacy service value through financial, operational, clinical, therapeutic, and regulatory expertise. We’re growing at a breathtaking rate. As a CPS employee, you will discover, along with our other 1800+ employees, that CPS is a company you’ll be proud to grow with. ***************************************************** Posted by Taylor Langston, Social Media & Sales Support Specialist at PharmacyWeek, Inc.

3/17/2013 41

Director of Pharmacy DOP (206-bed), Emanuel Med Ctr, Turlock, CA CPS (Located 15 mi South of Modesto) http://www.pharmacyweek.com/career/26640/Director-Pharmacy-California-Ca-Turlock _____________________________________________________________ Area DOP, Eureka, CA Cardinal Health http://www.pharmacyweek.com/career/25276/Director-Pharmacy-Eureka-Ca-California-Ca-Eureka ________________________________________________________ Pharmacist II - Temp, Covina, CA Cardinal Health http://www.pharmacyweek.com/career/26652/Pharmacist-Ii-Temp-California-Ca-Covina ******************************************************* To Apply Online: http://jobsearch.covance.com/39333-jobs.aspx If link does not work: www.covancecareers.com (ref 39333 in search box) Medical Writing Communications Manager – Remote Position http://jobsearch.covance.com/39333-jobs.aspx Covance - San Diego, CA (Greater San Diego Area) Job Description The Medical Writing Communications Manager key responsibility will include developing and executing publications/communication plans for internal customers and external clients. This position can be a remote based role but will support our San Diego CA location. Essential Job Duties: - Develop and execute publication/communication plans for internal customers and external clients* - Develop abstracts and poster/oral presentations for data dissemination at major scientific meetings and congresses for internal customers and external clients* - Provide technical support at major scientific meetings and congresses for internal customers and external clients* - Develop manuscripts, white papers, and review articles for submission to high-quality, peer-reviewed journals for internal customers and external clients* - Act as primary client lead for medical communications-related activities* - Assist the Head of Value Communications in the development of the medical communications department for CMA - Provide editorial support as needed for internal customers - Mentor Value Communication junior staff to grow and develop their skills. Ensure they attend appropriate Covance, CMA, and client-specific training programs. Desired Skills & Experience Education/Qualifications - PhD in scientific field preferred with 3 years experience in medical communications, including at least 2 years in medical writing - Master in scientific field acceptable with 4 to 5 years experience in medical communications, including at least 3 years in medical writing Experience - Excellent verbal and written communication skills - Scientific knowledge of therapeutic areas - At least 2 years experience and participation in scientific congresses and meetings - Leadership potential - Knowledge of and experience with medical affairs-related activities - Knowledge of medical, pharmacokinetic, and statistical terminology - Ability to be detail-oriented and yet pay attention to global strategies and “the big picture”

3/17/2013 42

- Ability to be innovative and “think outside the box” to provide novel solutions for internal customers and external clients *********************************************************** Apply on company website Biomarker Project Manager - Clinical Trials Quest Diagnostics- Valencia, CA (Greater Los Angeles Area) Job Description Quest Diagnostics (NYSE: DGX) is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Currently, we have an opportunity available for a Biomarker Project Manager at our Valencia, CA location. Responsibilities As a key contact for Sponsors, this individual will: - Participate in CLW meeting process to ensure during the life of the study, requirements of the clients and projects are met - Provide pro-active monitoring on the study to ensure accurate clean data for the client. - Facilitate regular review meetings to discuss pro-active problem resolution of study specific issues utilizing the necessary resources from all relevant internal departments - Manage all service related issues - Ensure clear communication, expectations and deliverables with the study team - Discuss and agree on special handling procedures and ensure these are defined in study specific SOPs, and all relevant groups understand and are trained on the requirements. - Ensure set-up of study meets all applicable Quality Standards - Collaborate with counterparts to ensure global consistency on global study set-up. - Prepare weekly / monthly metrics and /or study status reports. - Attend internal and client audits - Act as back–up for Project Manager (set-up) as necessary - Enter and result of study testing verification report requests; interact with laboratory personnel including Alliance and referral laboratories regarding resulting of study testing verification reports, requests and issues - Perform other duties as required by management in support of customers and the broader clinical trials organization Desired Skills & Experience - BS (Science based) degree or equivalent education and experience. - 3+ years of clinical trials experience or experience in a clinical laboratory, either technical, customer service or support operations-related. Multiple experiences preferred. Company Description Quest Diagnostics Incorporated (NYSE: DGX) is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers physicians the broadest test menu (3,000+ tests), is a pioneer in developing innovative new tests, is the leader in cancer diagnostics, provides anatomic pathology (AP) services, & interpretive consultation through its medical & scientific staff of about 900 M.D.s & Ph.D.s. The company has about 43,000 employees, serves approximately ½ of all physicians & hospitals in the U.S., & reported 2009 revenues of $7.5 billion. Quest Diagnostics offers the most extensive clinical testing network in the U.S., with

3/17/2013 43

laboratories in most major metropolitan areas, & in Mexico, the UK & India. The company also operates four esoteric laboratories, 40 outpatient AP laboratories, & 160 smaller, rapid-response laboratories. Patients may have specimens collected in any of the company’s approximately 2,000 patient service centers. On a typical workday, testing is performed for about 550,000 patients. With its MedPlus subsidiary, Quest Diagnostics empowers healthcare organizations & clinicians with state-of-the-art connectivity solutions. The company is the leading provider of pre-employment drugs-of-abuse screening for employers & risk assessment services for the life insurance industry. It is the world’s 2nd largest provider of clinical trials testing for new pharmaceuticals. Additional Information Posted:March 6, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Science, Health Care Provider Industries:Hospital & Health Care, Health, Wellness and Fitness Job ID:5046020 ********************************************************** Posted by Tom Hayes, Director Quality Assurance at Klein Hersh International Director of GMP plant compliance with a large cap client in the San Francisco Bay, CA area, contact me to learn more: 267-948-1440 Job: Director Quality Assurance in Castro Valley, CA A large cap pharmacuetical company is hriing in the San Francisco Bay area. If you are looking for a strategic leadership opportunity in pharma & medical device QA working as the head of compliance for a manufacturing facility keep reading! The Director of site compliancee - GMP will develop and deploy the quality / compliance program for a large manufacturing plant producing clinical and commercial Medical Devices (class I-III) and Biologics. This position oversees all quality assurance, quality engineering and quality control employees (roughly 100 FTEs). Responsibilities: •Assures systems and procedures for regulatory compliance are established and deployed. Periodically reviews the suitability and effectiveness of the quality system with executive management. Manages regulatory inspections. Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. •Directs large programs and departments in support of division or companywide initiatives. Is responsible for results in terms of product quality and conformance to regulations and company policies. •Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements. •Understands and deploys processes to assure conformance to regulations in a mid to large size plant or a large programs or department. Manages regulatory inspections. •Periodically reviews the suitability and effectiveness of the quality system with executive

3/17/2013 44

management •Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements. •Assesses and advises senior management concerning acquisition targets. •Interacts frequently with all levels of internal management as well as across functions and franchises. •Manages interactions with customers and regulators concerning the quality of products, systems and processes. •Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility. •Develops budget for a mid to large size plant or large programs/ department and ensures adherence to the budget. •Manages overall coaching, training, development and succession plans for the team. Job Requirements In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics. Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally. Strong analytical, problem solving, and decision making skills •Excellent verbal and written communication skills •Success working with multifunctional, global teams. •Excelle... http://bull.hn/l/11USP/2 ******************************************** Posted by David Kohl, Sr. Recruiter at Onyx Pharmaceuticals http://www.linkedin.com/jobs?viewJob=&jobId=5042955&trk=eml-anet_dig-b_premjb-ttl-cn&ut=05kHsI-dZ4yRE1 Sr. Manager, Clinical Data Management Onyx Pharmaceuticals- San Francisco Bay Area Job Description Essential/Primary Duties, Functions and Responsibilities

Recruits, trains and manages employees and consultants with area of responsibility; Develops training standards

Contributes to technical infrastructure of the Data Management and process improvement

3/17/2013 45

Provides operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring the Onyx established standards

Manages DM related timelines. Coordinates and synchronizes deliverables / milestones with the overall Study Execution Team timelines

Responsible for building effective DM vendor relationships for all assigned studies. Involved in RFP development, contract negotiation and selection of DM and/or technology, as needed. Escalates issues with proposed solutions, as necessary

Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications

Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions

Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards

Represent DM in Study Execution Team(SET) meetings; establishes and negotiates timelines with internal and external team members for completion of activities for a group of projects

Project management for DM deliverables for one or more projects as required Supports budget and resource planning across one or more projects Develops, applies and promotes consistent Data Management standards through

standard processes and SOPs Manages group of internal data managers, consultant data managers. Mentors and

develops direct reports provides training of the CRF completion guidelines, EDC system at Investigators'

meeting and to internal and external project members as needed Represents the DM function in external professional initiates and organization to identify

industry best practices May require travel up to 15% of the time

Requirements Work Experience:

Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 8 years of data management experience in the pharmaceutical or biotechnology industry plus 2 years of staff management experience, or MA/MS with 6 years of experience plus 2 years of people management experience

Minimum of 2 years in oncology Experience with an EDC system preferred Experience in working in and contributing to cross-functional teams

Education/Training: Requires Bachelors or higher in scientific discipline or equivalent combination of relevant

educational and professional experience. Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:March 6, 2013 Type:Full-time Experience:Associate Functions:Science

3/17/2013 46

Industries:Biotechnology Job ID:5042955 ________________________________________________________________________________ http://www.linkedin.com/jobs?viewJob=&jobId=5042955&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3AuBdQDvhayRE1 Apply on company website Sr. Manager, Clinical Data Management Onyx Pharmaceuticals- San Francisco Bay Area Job Description Essential/Primary Duties, Functions and Responsibilities

Recruits, trains and manages employees and consultants with area of responsibility; Develops training standards

Contributes to technical infrastructure of the Data Management and process improvement Provides operational leadership to the direction, planning, execution, collection and handling of all

clinical data to the highest quality standards while ensuring the Onyx established standards Manages DM related timelines. Coordinates and synchronizes deliverables / milestones with the

overall Study Execution Team timelines Responsible for building effective DM vendor relationships for all assigned studies. Involved in RFP

development, contract negotiation and selection of DM and/or technology, as needed. Escalates issues with proposed solutions, as necessary

Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications

Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions

Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards Represent DM in Study Execution Team(SET) meetings; establishes and negotiates timelines with

internal and external team members for completion of activities for a group of projects Project management for DM deliverables for one or more projects as required Supports budget and resource planning across one or more projects Develops, applies and promotes consistent Data Management standards through standard

processes and SOPs Manages group of internal data managers, consultant data managers. Mentors and develops direct

reports provides training of the CRF completion guidelines, EDC system at Investigators' meeting and to

internal and external project members as needed Represents the DM function in external professional initiates and organization to identify industry

best practices May require travel up to 15% of the time

Requirements Work Experience:

Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 8 years of data management experience in the pharmaceutical or biotechnology industry plus 2 years of staff management experience, or MA/MS with 6 years of experience plus 2 years of people management experience

Minimum of 2 years in oncology Experience with an EDC system preferred Experience in working in and contributing to cross-functional teams

Education/Training: Requires Bachelors or higher in scientific discipline or equivalent combination of relevant

educational and professional experience.

3/17/2013 47

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:March 6, 2013 Type:Full-time Experience:Associate Functions:Science Industries:Biotechnology Job ID:5042955 ____________________________________________________________________________________ Manager, Study Builds & Clinical Data Programming South San Francisco, CA This oversight role is responsible for the delivery of study builds and clinical programming requests. Study builds includes the set up and deployment of technologies such as EDC, Coding, IVRS and Safety Gateway. This role will also be responsible for the development of SOPs and performance metrics related to Study Build and Clinical Programming. ___________________________________________________________________________ ******************************************************* Started by Ashley Reynolds, Program Manager at BIOCOM Institute For more information, visit www.biocollaborative.com. Free training for veterans to move from military into life sciences in San Diego. A group of San Diego companies are working together to help military veterans enter their industry. Now, the BioCollaborative Life Science Immersion Program in San Diego is helping veterans go from life on the battlefield to life sciences. "A lot of people in the military only see a life science career as a lab coat," explained Kristie Grover, executive director of BIOCOM Institute. That is one reason why they are having trouble filling the 100-plus spots for their online training course, which is free for veterans. About 40 veterans are in some phase of the roughly 100-hour course launched 18 months ago. The course is a much-needed tool to battle unemployment at 10.4 percent among local military veterans in 2011, and nearly 13.5 percent for veterans in the 18-34 age group, according to a recent report from the San Diego Regional Chamber of Commerce. The program not only connects veterans with mentors, but it follows up after the course with job opportunities and interview tips. The program is also open to non-veterans. *****************************************************

Respond via email: [email protected] Post Doctoral Scientist, Assay Development—Atila Biosystems, Mountain View

3/17/2013 48

Position Summary: Invention of new assay techniques is central to this work. We are seeking a highly talented and motivated postdoctoral Scientist with experience in molecular diagnostics, specifically RNA and DNA diagnostic development. The ideal candidate will have experience in nucleic acid chemistry, real-time PCR, probe design, DNA Circuits design, and strong molecular biology skills. This position will be responsible for the development, optimization, qualification/validation, implementation, and writing technical reports, test methods, protocols, and other documentation of quantitative assays to support nucleic acid amplification and detection products, and enzymatic assays. Desired Skills and Experiences:

Ph.D. or MS. in Molecular Biology, Chemistry, Biochemistry, Analytical Chemistry, Bioanalytical Chemistry or related filed. Experience developing assays and kits for nucleic acid amplification and detection. The Scientist will develop and execute Nucleic Acid Diagnostic development, and sample collection/processing approaches. Experimental strategies include RNA and DNA preparation from tissue and other bodily fluids, RT-PCR based assay development relating to single base mutation detection, DNA circuit design, T7 transcription, cDNA synthesis. He/she may supervise Research Associates/technicians and coordinate with technical transfer of developed assays.

Expert proficiency in the use of standard molecular biology techniques (DNA amplification, real time PCR, probe design, BLAST, cDNA synthesis, T7 transcription).

Expert proficiency in fluorescent and luminescent assay detection platform, especially Real time-PCR and luminex platform.

Demonstrated success in developing and optimizing in vitro enzyme assays. In addition to impeccable technical skills, successful candidates should possess strong

organizational and communication skills, as well as be able to work within a team and thrive in a fast-paced start-up environment.

Responsibilities: This will be primarily a hands-on, bench level position with key responsibilities in the area of multiplex PCR based assays. The successful candidate must have a strong general science background in several disciplines and possess skills associated with IVD product development. This candidate will be involved in all aspects of assay development including design of nucleic acid isolation methods from different sample types, design of highly multiplexed, real-time PCR and RT-PCR assays, probe design and validation, creating and validating test methods, systems integration, capable of hands-on work at the bench as well as directing others to meet timelines successfully. About Atila BioSystems: Atila BioSystems, Inc. is a start-up company located in Mountain View, CA, developing novel technologies for molecular diagnostics. We are looking for energetic and highly productive scientists to join our fast-paced, goal-oriented team.

**************************************************** To Apply: To respond to this position please visit: http://ejob.bz/ATS/jb.do?reqGK=662382 Biorepository Manager Insperity Client- Thousand Oaks, CA (Greater Los Angeles Area) Job Description BioStorage Technologies is the premier, global provider of comprehensive sample management solutions for the bioscience industry. We were founded in 2002 and are a privately held organization headquartered in Indianapolis, Indiana with an additional full-service site near

3/17/2013 49

Frankfurt, Germany. Our mission is to provide our clients with world class, biorepository services, exceeding clients’ expectations of service, value and quality while setting the industry standard for the storage, management and logistics of samples. Biorepository Manager of On-Site Solutions Utilizing your working relationships and leadership skills, you will provide direct, hands-on leadership of all Biorepository and Sample Preparation personnel. In managing these multidisciplinary personnel, you will ensure quality execution of Biorepository policies and procedures. You will also direct and implement the day-to-day tactical activities associated with Biorepository activities and Sample Preparation. We will rely on you to create and implement Biorepository and Sample Preparation policies and procedures which result in attaining departmental milestones and achieve high levels of client satisfaction. Responsibilities include:

Oversee day-to-day operations of Biorepository including: o Receiving and coordinating retrievals of materials coming into and leaving the

facility. o Contact and handling of potentially biohazardous materials including blood, body

fluids and other tissues from various sources (typically in a frozen state) o Working with biological materials at various temperatures o Data entry of information related to the biological materials into a proprietary

computer database o Sample preparation services as directed by customer of BST protocols

Provide leadership of multidisciplinary teams toward a common objective Responsible and accountable for all activities and outcomes of assigned personnel Responsible for overall fiscal management of areas of responsibility; ensure all

quoting/billing documents are harmonized and accurate Responsible for monitoring obligations in client master service agreements and

contracts to ensure that Biorepository and Sample Preparation activities meet these contractual obligations

Create actionable strategies that ensure the smooth and timely start-up, integration, and quality execution of Biorepository and Sample Preparation projects

Develop metrics and new business processes that align with a global strategy and achieve consistent high levels of client satisfaction

Propose recommendations and solutions that increase the likelihood of consistent operational success

Develop appropriate best practices resulting in standardized and streamlined global processes and efficient use of resources

Establish overall department vision and drive for continuous improvement initiatives, develop and monitor effective performance metrics, and coach and develop department members

Work with other functional areas to develop and implement project and resource planning

Identify, monitor, and maintain the appropriate department resources to successfully achieve milestones and high levels of client satisfaction

Determine and monitor cost drivers to assist in prospective identification of profitability and resource planning

Balance workload within and across departments to meet operational and client requirements

Develop and implement an integrated and effective planning (resource planning, specimen project grouping, etc.) and forecasting tool

Develop, implement and monitor processes that strive for an effective balance between flexibility/customization and process efficiencies designed to work effectively across

3/17/2013 50

functional departments, to remove potential roadblocks and resolve organizational conflicts concerning people, resources, facilities, etc.; and that ensure appropriate escalation of issues and continuous, appropriate communication of issues across the organization

Communicate regularly with sales account managers for assigned clients; develop relationships with targeted clients

Ensure all service failures are identified, investigated, and resolved appropriately; proactively manage and drive the resolution of client issues; promote continuous process improvement

Work closely with the Sr. Director of Global Biorepository Operations and staff to develop strategic initiatives that focus on overall performance metrics, client satisfaction, and leading indicator mechanisms that are meaningful and drive quality and efficiency improvements

Provide general scientific and operational knowledge to Sample Preparation and Management

Ensure maintenance of all facility equipment including freezer units and generator is done timely and in accordance with BioStorage Technologies SOPs

Desired Skills & Experience Qualifications:

Bachelor’s degree in a Science related field required; Master’s degree preferred Fluent in English (verbal and written) Minimum 5 years of clinical laboratory experience Minimum 3 years of management and supervisory experience Excellent computer skills in MS Word, Excel and Outlook Proficient with Internet for research and working with companies, Strong orientation to detail Good working and communication relations with colleagues and customers Flexible and adaptable to changing work environments Demonstrated high level of initiative and ability to work independently Ability to organize, prioritize and manage workflow Ability to initiate and complete tasks Excellent problem solving skills

Preferred:

Master’s degree in science related field Multi-lingual Successful completion of graduate-level business courses Central laboratory experience

Working Conditions:

Working in an area with potentially infectious materials. Responsible for maintaining a clean work environment and enforce universal

precautions for pathogens when working in an area considered to be potentially contaminated.

Some travel up to 10%, including international travel may be required. Benefits: We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where

3/17/2013 51

each person feels encouraged to contribute to our processes, decisions, planning and culture.Additional Information Posted:March 5, 2013 Type:Full-time Experience:Mid-Senior level Functions:Engineering, Information Technology Industries:Information Technology and Services Compensation:Excellent Salary + Benefits Package Employer Job ID:662382 Job ID:5031030 *************************************************** Posted by Don Lim, Sr. Recruiter at Onyx Pharmaceuticals Apply Here - http://jobvite.com/m?3cUFJfwe Sr. Manager, Clinical Data Management | South San Francisco, California Join Onyx Pharmaceuticals, Inc.hire.jobvite.com *********************************************************** Director Business Development Adamas Pharmaceuticals, Inc.- Emeryville (San Francisco Bay Area) Job Description The Director of Business Development will be responsible for corporate partnering and alliance management activities and contractual relationships for the Company. The ideal candidate will be a business-minded operational leader who will bring strong corporate transaction, alliance management, and general operations expertise to Adamas. This person will also have responsible for managing critical supplier and contracts. This individual will lead our internal and external business development and partnering activites, and actively collaborate with product development, medical affairs and finance to achieve her/his objectives. This position will report to the CFO. Desired Skills & Experience Responsibilities:

Spearhead business development initiatives consistent with the Company’s overall strategy

Responsible for internal planning and execution of strategic partnering activities and alliance management

Responsible for managing all development and commercial aspects of outsourcing arrangements in support of the corporate strategy

Manage complex contract negotiations and work with outside legal counsel Working closely with the other members of the executive team, participate in strategic

planning and assist in development and management of the market and commercial assessments

Conduct initial high level business fit and scientific evaluation of potential in-licensing opportunities to determine if they are worthy of further, detailed functional evaluation

Qualifications: At least 10 years in business/corporate development and transactions, with multiple

demonstrated successful partnerships at a high growth Biotech, Medical Device or related Healthcare company

Experience in evaluating in-licensing/out-licensing commercial opportunities through partnered collaborations

Excellent interpersonal skills Excellent verbal and written communication skills Excellent quantitative modeling skills Advanced degree (MBA or PhD) preferred

3/17/2013 52

Company Description Adamas is a clinical stage pharmaceutical company focused on advancing its aminoadamantane-based therapeutics programs for disorders of the central nervous system, including Alzheimer’s disease and Parkinson’s disease. Adamas was founded in 2004 to develop new therapeutics for CNS disorders based on improvements to an underutilized class of drugs called aminoadamantanes, including amantadine and memantine. Today, with operations in Emeryville, CA and Bangalore India, Adamas is developing controlled release versions and optimized fixed dose combinations of aminoadamantanes to improve tolerability and clinical efficacy, and to provide superior clinical and health economic benefit. Adamas Pharmaceuticals, Inc.Additional Information Posted:February 26, 2013 Type:Full-time Experience:Director Functions:Business Development Industries:Pharmaceuticals Job ID:4884507 **************************************************** Apply on company website Dir, Product Marketing - 9572 Affymetrix, Inc.- Santa Clara, California (San Francisco Bay Area) Job Description Position Summary: Responsible for executing strategic product management responsibilities associated with current and future clinical molecular cytogenetic testing applications. This position will be accountable for product management and business activities pertaining to the relevant portfolio including, but not limited to, strategic product management and portfolio positioning of existing products, collaboration development, product and platform positioning, and marketing communication strategy. This position is also accountable for the creation of a portfolio strategy and roadmap to inform future product development decisions. New product development activities include financial business case development, market research, voice of customer, requirements development, core team leadership, and new product launch activities. This role interacts deeply with all internal business functions as well as customers, regulatory bodies, and global field-based personnel. The role requires a technical knowledge of cytogenetic applications and molecular genetics. Requirements: 1 Strategic product management and product lifecycle activities associated with existing and new product management 2 · Strong background in molecular diagnostic applications · Experience developing clinical products for regulated markets

3/17/2013 53

· Experience managing an integrated application & hardware platform (assay, software, and instrumentation) a plus 3 Key skills and competencies · Effective documentation of voice of customer / developing products for competitive advantage · Business case development / analytical capabilities · Effective participation in phase-gate product development processes · Direct experience developing clinical products for regulated markets · Superior communication skills · Excellent team player · Highly flexible and willing to take on new assignments in emerging focus areas · Strong cross-functional execution experience · Takes initiative without being coached · Excellent planning and scheduling skills · Knowledge of key accounts and key researchers 4 Partners closely with field sales teams and global business leaders to align strategic priorities and ensure a balanced approach to current and future product development activities. 5 BS/BA or Higher with experience in cytogenetics and/or molecular diagnostics MBA a plus 5 year+ related experience in marketing, sales, business development, or program management 7 Key competencies: · Strong cross-functional execution experience · Excellent communication skills · Takes initiative without being coached · Excellent planning and scheduling skills · Experience working in a structured product development environment Travel: 30-50% Primary Working Relationships: Reports to Clinical applications market leader. Works across functions including Field Sales and Marketing, Program Management, Manufacturing, Product Development, Finance, Legal, Quality Assurance, Regulatory Affairs, Corporate Business Development, Software development as well as with external business partners. Level of Autonomy and Complexity: Participates in department decision making in relation to procedures, continuing education for self and peers, and strategic business planning. Performs most job functions independently and at a high level, utilizing resources appropriately to fulfill job responsibilities in a cost-effective manner. Works independently and is highly motivated. Primary Duties and Responsibilities:

3/17/2013 54

Directs the development of business and marketing plans and manages product lifecycles

Oversees market research, monitors competitive activity, and identifies customer needs Directs market opportunity and product requirements definition, pricing strategy and go

to market plan Monitors product development, working with R&D Provides forecasts and monitors resolution of product quality issues, working with

Operations Interacts with key thought leaders, working with Commercial Operations 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 Education:High School Bachelor's Yrs of related experience:8-10 years managerial Competencies: (skills, knowledge, abilities) Interpersonal skills, Results oriented, Change Leader, Understand complex scientific information Program Project Management Licenses/Certificates:None Travel Requirements:Up to 20% Working Conditions:Office 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

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

Additional Information Posted:February 20, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Biotechnology Employer Job ID:9572 Job ID:4931506

3/17/2013 55

***************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4862242&trk=rj_em&ut=2bVSNy454py5E1 Pharmaceutical Director / Sr. Dir of Marketing - Oncology The Alpine Group- San Francisco Bay area Job Description Breakthrough science. Positive corporate culture. A start-up drug company is expanding their commercial team and needs a Director / Sr. Director of Marketing to lead their oncology franchise. This dynamic, high-growth organization has tripled in size in the two years and has three products in various stages of commercial and clinical development. If you have a strategic orientation and enjoy a creative challenge, this could be the opportunity for you. With a business model based on developing novel pharmaceuticals for critical, unmet medical needs, this is an exciting culture where their teams have unusually strong personal chemistry. And the dynamic nature of a start-up environment means that everyone is pitching in and working hard to get the organization to the next level. We are now looking for an entrepreneurial, strategic thinker to lead their oncology marketing team. The Role The Director / Senior Director will be responsible for all strategic and tactical marketing for a line of novel oncology compounds in the solid tumor segment. You will manage a team of three marketing professionals and lead the product lifecycle planning for their inline brands. Specific duties include market segmentation, positioning, branding, managing agencies for promotional programs and market research, and supporting the sales team. Your team will also develop Key Opinion Leader strategies and Medical Education programs, and will lead the Advisory Boards and Speaker’s Bureau. As new indications and products move through clinical develop you will also create and execute launch plans. This is a broadly defined role in a small, emerging organization where you will “wear many hats.” Other duties include coordinating the publication strategy and medical congresses with Clinical and Medical Affairs, assessing pre-clinical oncology pipeline opportunities, and developing reimbursement and pricing strategies. You will also analyze and track competitors for current and future indications of the oncology portfolio. This is a high profile, creative role requiring extensive commercial leadership, where you will interact on a routine basis with Senior Management. The rapidly expanding organization means there are significant opportunities for career development and advancement. Overnight travel is estimated at 20-25%. Desired Skills & Experience The successful candidate will have the following qualities:

10+ years of pharmaceutical or biotech industry experience in some combination of marketing, new product planning, and sales related assignments

8+ years of in-house oncology marketing experience, including product launch experience

3+ years of direct supervisory experience of oncology marketing personnel A willingness to be a “player-coach” in a leadership role that requires both strategic

planning and tactical execution Bachelor’s degree required; MBA preferred

Company Description The Alpine Group serves only the Medical Technology industry, including the Pharmaceutical, Biotech, Medical Device and Diagnostic markets. Our clients choose us because we are specialists rather than generalists. As niche recruiters, we bring our clients market mastery, trusted counsel and - most of all - expedited results. Since 1999, we've helped over 125 different medical technology organizations hire Impact Players in positions ranging from individual contributor to Chief Level leadership. Our current

3/17/2013 56

client list includes large, multinational organizations like Novartis and Medtronic down to small, emerging organizations - including start-ups. The Alpine Group has achieved the MRI Network "President's Club" award for top 20% performing offices each of the past eight years, winning the Regional Office of the Year Award six times since 1999. Our recruiting approach differs from the majority of other recruiting firms. We invest time in getting to know about each candidate's career interests and qualifications and only then do we present an opportunity that might be a fit, rather than emailing a job description and asking who they may know that would be interested. With this approach we can not only match great people with great opportunities, but we also know when to contact them again when new opportunities arise that might be of interest. Our approach takes more time up front, but pays big dividends later for clients who need to hire quickly and candidates who appreciate the efficiency and candor. We think you'll find that the recruiting experience you'll have with us is different from what you may have experienced with other Search Consultants in the past. Give us a call and see what The Alpine Group can do for you! Additional Information Posted:February 12, 2013 Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals Job ID:4862242 ********************************************************* To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-87928 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Director of Sales ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Responsible for representing all company products, maintaining base business, acquiring new business and meeting or exceeding annual sales goals. 2) Maintain call frequencies at hospitals, laboratories and physician accounts. 3) Represent the company to the customer in a manner that demonstrates the highest degree of integrity. 4) Attain a practical understanding of company products, methodologies and competition. 5) Utilization of good selling skills that allows for the identification of need and presentations based upon identified need. 6) Completion of tenders and presentations within assigned territory. 7) Have good understanding and working ability in Microsoft programs. 8) Strong relationship building skills with customers, vendors and co-workers. 9) Prompt reporting of competitive information and updates as to existing market conditions. 10) Update and adjustment of current customer base pricing.

3/17/2013 57

11) Aid in the training and development of new sales employees. 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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Director Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159187928 Job ID:5001080 ********************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4950125&trk=rj_em&ut=2aLXuHmHojy5E1 Sr.Director/Director of Marketing Sciton, Inc.- Palo Alto, California (San Francisco Bay Area) Job Description Develop and implement worldwide marketing strategies to achieve corporate sales and marketing objectives. Lead 14 person marketing team. Reports to Executive Vice President, Sales & Marketing.

3/17/2013 58

Specific Duties and Responsibilities: Coach/mentor marketing team members Identify market opportunities and mobilize resources to capitalize on them Drive the development of marketing materials and sales tools for the worldwide market Develop and implement marketing and promotional programs plus monitor and

evaluate them to determine their success Prepare launch plans for effective promotion of new products and applications

worldwide Cultivate relationships with key physicians worldwide Train worldwide sales and marketing teams Develop and work within program budgets Investigate new markets and play an active role in the product development function

for new applications, products and product improvements Develop knowledge of competitive products and companies and develop marketing

strategies to win against them Move Sciton to the forefront of digital and multimedia marketing Develop worldwide print and digital media plan Plan and execute worldwide trade shows Approximately 25-35% travel is required including international

Desired Skills & Experience 15 plus years of successful marketing or related business experience at consistently

more senior levels Demonstrated leadership skills Ability to work effectively within the Sciton team (Engineering, Manufacturing, Service,

Regulatory, Sales, Finance) Strong oral and written communication skills and project management skills Ability to execute against both short-term deliverables and long term strategic

initiatives Technical understanding of medical devices related to the aesthetic industry (lasers) Clear understanding of upstream and downstream marketing with emphasis on

downstream Successful track record in similar position BS or BA in Marketing, business or technical field MBA or other advanced degree preferred

Company Description Sciton is committed to providing best-in-class laser and light source solutions for medical professionals who want exceptional durability, performance and value. Sciton offers superior medical devices for fractional and full-coverage skin resurfacing, superficial and deep skin peeling, hair removal, phototherapy, wrinkle reduction, laser-assisted lipolysis, treatment of vascular and pigmented lesions and varicose veins, nail fungus, scar reduction and acne treatment. Additional Information Posted:February 22, 2013 Type:Full-time Experience:Director Functions:Marketing Industries:Medical Devices Job ID:4950125 Veteran Commitment

Sciton, Inc. commits to hiring returning veterans. Learn more »

3/17/2013 59

******************************************************** Sales Area Manager/Sales Rep of Neurovascular Intervention Products Asahi Intecc USA, Inc. Job Description This position will be responsible for the sales of Neurovascular intervention products. Responsibility includes -Sales activity -Product training to phycicians and lab staff - Promotion and tradeshow support - Clinical case observation and market feedback - Marketing activity support Date Posted: 3/1/13 Location: Any location in US, CA Years Experience: +3 years in the neurovascular intervention ****************************************************** Apply today online at www.hemacare.com. EOE M/F/D/V Posted by Lou Juliano, Sr. Vice President, Research Products & Cell Therapy at HemaCare Corporation - Administrative Sales Coordinator (Los Angeles based) HemaCare Corporation is a blood products and services company serving healthcare providers and the scientific community for over 30 years and we are GROWING! We have an immediate opening for an energetic and motivated Sales Coordinator who wants to join our team and expand HemaCare’s ever increasing clinical research division. You will be supporting our Research Sales Team in different capacities. Our various market segments consist of Pharmaceutical, Biotechnology, Vaccine and Academic R&D. Essential Responsibilities • Assist with the processing and renewal of quotes. • Process and track large volume orders to confirm the receipt of the purchase order, ensure that the fresh cell products are placed on the demand or that cryopreserved products are available and that the order will ship on the promised date. Follow up with customer to ensure that shipment was received and that it meets the customer’s expectations. • Perform customer billing • Assist with receivable collections from new research customers • Help to create and maintain an updated customer database • Manage customer contracts • Create projects that correspond with the release of new products or special promotions to increase customer awareness and create sales opportunities for the sales representatives. Projects include the creation of a “customer contact list”, calling or emailing customers to measure interest, entering leads into customer database and forwarding to the appropriate sales rep.

3/17/2013 60

• Tradeshow management - Responsible for tradeshow registrations, shipment of materials and literature, arrangements for booth set up and all other aspects. Contact attendees to invite them to HemaCare booth. Assist with booth coverage, enter leads into customer database, forward “hot” leads that need immediate attention to appropriate sales rep and pre-qualify remaining leads by contacting customers to clarify their needs, products of interest and timelines. • Manage customer complaints. Address concerns as needed to achieve a win-win outcome. • Build customer database -search for new customers to build database by using websites of major universities, medical schools, research centers/facilities and biotech companies along with Navigrant, Google Scholar and other available resources. • Help create flyers or toss sheets for sales reps to use at vendor shows or visits to customers in the field. • Assist with the organization of Research Team Sales Meetings (arranging for meeting locations, activities, hotel reservations). • Run sales trend reports for SVP and Research Sales Team Desired Skills & Experience • Bachelor’s Degree in Business, Marketing, or Life Sciences • Experience supporting or working in a sales/customer support type role • Strong knowledge & use of all Microsoft Office products is required • Accounting experience is preferred • Goldmine experience is preferred HemaCare offers a competitive compensation package based on experience and excellent benefit package. If you like a challenge and want to be part of a dynamic growing team this job is for you! ********************************************************** For more information, please contact me at [email protected], 415-491-1541. QA COMPLIANCE/SYSTEMS MANAGER/SR. MANAGER We are looking for external and internal auditing exerience and some experience developing systems. Travel is 30% mostly in the US. This is a ground floor opportunity to create a program for a small cell therapy company located on the Peninsula. Biologics experience preferred. ___________________________________________________________ QUALITY CONTROL MANAGER/SR. MANAGER This position requires flow cytometry experience and either cell therapy or gene therapy experience in your career history. Will manage 2. Client is a cell therapy company located on the Peninsula. Your referrals are so appreciated. For more information contact Nancy Symonds, President, NJS Recruiting Services, [email protected], 415-491-1541. ******************************************************** Apply on company website Business System Analyst (SAP FI/CO) Mizuho OSI- Union City, CA (San Francisco Bay Area) Job Description Requires: 3-4 years of experience with SAP FI/CO modules and a Bachelor's degree in computer science or other applicable field. Who We Are: Since 1977 Mizuho OSI has been enhancing patient outcomes as the industry leader in the design and manufacture of Specialty Orthopedic Surgical tables and patient positioning devices. Mizuho engineers, working with leading Orthopedic Surgeons, continuously develop new surgical techniques to drive the market. Our company has a strong market share, is financially stable; and performed well and beyond expectations in 2012.

3/17/2013 61

Who You Are: You are a results driven, deadline smashing, analyzing and implementing machine. You eat, breathe and live SAP and you are an evangelist for positive change. Of course you are a great business analyst - you know how to independently analyze needs, scope out the results needed for a project, design, implement, train and support. You are particularly strong with the SAP FI/CO modules. You have proven yourself as a liaison between IT and Finance. You spend a lot of time listening, observing, documenting, and analyzing. When you speak, you are clear, concise, and present intelligent recommendations. When you write, people at every level of the business get the message and take action. Bachelor's degree in computer science or related field? Check. Three or more years of relevant work experience? Check. Experience working in an FDA regulated environment? Not required but we'd love to see it. Duties:

Meet aggressive deadlines with high quality results. Undertake extensive program and structural database development tasks. Review business requirements and detailed specs to develop test scripts and testing

plans with schedule. Develop work plans, managing deadlines and coordination of projects team and sub-

team activities. Work with different functional areas across the company to identify research and

resolve complex data issues, in a timely manner, with minimal impact to the integrated system.

Support integration efforts of Programs and Projects; set and control project scope. Create User Acceptance (UAT) test scripts to the approved requirements. Handle change requests and bugs resulting from the UAT process, ensuring completion

and retesting. Desired Skills & Experience Qualifications: Requires: 3-4 years of experience with SAP FI/CO modules and a Bachelor's degree in computer science or other applicable field or equivalent combination of education and experience. Company Description BENEFITS At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more. FOR OUR SERVICE MEMBERS AND VETERANS Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact Ron Katz, PHR at (510) 429-1500 x202. FOR PERSONS WITH DISABILITIES If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact Ron Katz, PHR at (510) 429-1500 x202. MIZUHO OSI IS AN EQUAL OPPORTUNITY EMPLOYER Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws. Additional Information Posted:March 4, 2013

3/17/2013 62

Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Medical Devices Compensation:DOE plus annual bonus potential Employer Job ID:33-11a Job ID:5021346 ****************************************************** Apply on company website Senior Project Manger, Medical Device / IVD Alere, Inc.- San Diego, CA (Mira Mesa) (Greater San Diego Area) Job Description Position Overview: The overall responsibility of this position is to facilitate and manage all aspects of assigned projects including new product commercialization projects, on-market design changes and large scale quality initiatives. Interview dates for this role are planned for March 20thand 21st. Organization Chart: This role reports to the Program Manager of Project Management. No direct reports in the short term, possible future reports (Project Coordinators or Associate Project Managers). Major Functional Objectives:

Effectively manage the Cardiac Normalization team to the project plan and timeline with minimal supervision within 3 months. This project involves the creation of a new Design History File for an on-market product.

o Additional planning is required and should be completed within this 3 month period.

Ensure project team compliance with applicable company guidelines and regulatory requirements within 1 month.

o Complete all of the assigned Master Control training within a month Generate monthly project status reports including milestones, progress to plan, project

risks, project issues and recommended mitigations within 3 months. Analyze project schedule variances to recommend and implement corrective action

plans to eliminate or minimize schedule delays. Effectively manage a second project concurrently with the Cardiac Normalization project

within 6 months. Provide mentorship to junior staff members by guiding them through design control,

regulatory guidance questions and project strategy within 12 months. Subordinate Objectives:

Schedule and facilitate project team meetings to meet project goals. Schedule design reviews, generate meeting minutes and track action items to

completion. Develop, monitor and update project plans to ensure data integrity. Identify, analyze and provide possible solutions regarding resource and scheduling

conflicts between projects. Review project deliverables for consistency, compliance to procedures and

completeness. Process documents and labeling through the approval process. Provide guidance to Operations on On-Market Design Changes.

Management & Organizational Challenges: High expectations from Management in terms of project timelines with limited resources

and multiple competing priorities. Dynamic work environment resulting in routine shifting priorities and projects.

3/17/2013 63

Changes & Improvements Necessary: Improve project design control deliverables to increase value to the project team and

compliance to the regulations by creating or working with others to create new design file structure, framing, or templates where needed.

Problems to be solved: Work with appropriate parties to manage and resolve project issues (technical,

resourcing, strategy, timing, etc.), getting people with different agendas aligned in an environment filled with complex information.

This role will need to influence across the organization at Supervisor to Vice President levels in Quality, Operations, Regulatory, Strategic Business Units (SBU), and other areas.

Technical Skills in actual situation: Knowledge of design controls needed to generate and execute a compliant product

development and commercialization project or an on-market design change project. Proficient project management methodologies and techniques to effectively manage a

cross-functional team to deliver to the desired goal. Team Skills in Actual Situation:

Collaborative. Knowledge transfer. Ensure the accuracy and effectiveness of inter and intra departmental communications. Interpersonal skills Influencing skills Troubleshooting skills Teamwork

Environment / Culture: The job holder will be resilient, determined to deliver results, with high energy levels. They should be able to handle complexity and changing circumstances and be able to

communicate effectively to a wide audience. The job holder should be receptive to working in a fast-paced, constantly changing work

environment that demands they step out of their comfort zone on a day to day basis. They must be able to stay calm in pressure situations and be able to influence others to

take decisions based on business needs. Desired Skills & Experience Basic Requirements:

Minimum of 5 years experience in the medical device industry or similar regulated environment with over 10 years overall experience in influencing and decision making roles.

Minimum of 6 years experience in project management. Understanding of design control strongly preferred. Understanding of manufacturing systems (documentation, compliance, inventory

control, production scheduling / controls, etc.) Working knowledge of federal and other applicable regulations. For example: QSRs,

ISO, ISO 13485, and CMDR. Proficient in the use of MS Office applications (Word, Excel, Project, Visio, etc.) Excellent written and verbal communications skills. Detail oriented. Minimum of BA or BS degree preferably in a scientific or technical discipline. Certification in Project Management preferred.

Company Description By developing new capabilities in near-patient diagnosis, monitoring and health management, Alere Inc. (NYSE: ALR) enables individuals to take charge of improving their health and quality of life.

3/17/2013 64

A global leader in rapid point-of-care diagnostics, our products, as well as our new product development efforts, focus on infectious disease, cardiology, oncology, drugs of abuse and women's health. Being a leading developer of innovative diagnostic and monitoring devices allows us to combine near patient monitoring tools with value-added healthcare management services in order to improve care and lower healthcare costs for both providers and patients. Alere is headquartered in Waltham, Massachusetts. Additional Information Posted:March 4, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management Industries:Medical Devices Employer Job ID:03393 Job ID:5021920 ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=4924B304-3585-430F-B029-AEAE1A2410F4&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Compliance Consultant 2 DJO Global Job Description DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Compliance Consultant 2at our Corporate Headquarters in Vista, CA. JOB DETAILS • Responsible for researching, monitoring and executing compliance tasks of intermediate scope, complexity and risk. • Participates in and provides compliance support for projects and initiatives with moderate risk to identify, assess and mitigate compliance risk in business activities. • Develops and implements testing methodologies to evaluate the effectiveness of compliance policies, procedures and processes. • Identifies, documents and reports findings and issues to compliance management. • Creates corrective action plans, communicates and manages the change to ensure compliance with federal, state, agency, legal, regulatory and internal requirements. • Works on special projects and audits as assigned EDUCATION & EXPERIENCE • Bachelors Degree required. • Minimum of 3 years of experience in compliance. • Knowledge of AdvaMed (or PhRMA) Code of Ethics preferred. • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. • Ability to be interactive with executives and other senior level personnel. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Computer skills: Excel, Visio, Word, Access. ABOUT DJO GLOBAL DJO Global is headquartered in San Diego, CA (Vista). The Company's products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from

3/17/2013 65

degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company's medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Our product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare® and DJO® Surgical. ********************************************************** https://jobs.smartbrief.com/action/listing?listingid=376D8178-AF77-4ADE-860C-E682DEA973A1&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 Sales Area Manager/Sales Rep of Neurovascular Intervention Products Asahi Intecc USA, Inc. Job Description This position will be responsible for the sales of Neurovascular intervention products. Responsibility includes -Sales activity -Product training to phycicians and lab staff - Promotion and tradeshow support - Clinical case observation and market feedback - Marketing activity support ********************************************************** Apply on company website Are You All That and a Chip Factory?!? Manager/Sr. Manager Global Marketing Communications Needed Onyx Pharmaceuticals- South San Francisco (San Francisco Bay Area) Job Description Do you enjoy working in a fast-paced environment? Can you adapt well to ever-changing situations? Can you communicate clearly and concisely to broad audiences inside and outside an organization? Are you a qualified professional with at least 5 years of marketing, writing, and/or pharmaceutical experience with a passion for learning? If you answered no to any of the questions above, this position is not for you. The Global Marketing Communications Specialist (GMC Specialist) position requires the advanced ability to collaborate and communicate across all levels and departments within our organization, as well as manage critical internal processes and execute highly visible tasks including copy editing and dialog facilitation. This is primarily a process management role requiring a well-seasoned individual who will work closely with product marketing management, regulatory, legal, and medical teams in the management of our promotional

3/17/2013 66

review committee (TROPIC) and medical review committee. Onyx Pharmaceuticals is growing at an accelerated rate, and the capabilities and responsibilities of the GMC team are expanding in line with that growth. Sound good to you? If you’d like to know more about this position and Onyx please read on, and if intrigued, apply! Desired Skills & Experience Essential/Primary Duties, Functions and Responsibilities:

Participates in the development of plans for product promotion in support of marketing objectives.

Supports communications projects in the areas of advertising and promotional programs, public relations and trade shows, including Internet-based communications.

Responsibility may include managing agency contracts as needed. May serve as editor for formal business communications.

Responsible for confirming TROPIC reviewer comments have been incorporated into final piece submissions

Review all TROPIC documents for editorial accuracy Collaborate closely with AOR and internal stakeholders to ensure implementation of

requested edits Track all pieces through the TROPIC process and provide status and output reports as

required Coordinate with warehouse liaison to ensure document delivery to archive Maintain electronic archival of all final pieces and related documents Facilitate electronic project work streams via Livelink Be familiar with and support the submission of marketing materials to external

regulatory authorities Work within the timeframe allowed to meet project timelines Serve as a resource to company personnel to allow appropriate access to documents

including retrieval and photocopying/scanning, or downloads of documents as requested Work Experience:

Minimum five (5) years successful pharmaceutical work experience. Preferably 2-3 years experience in marketing and/or communications

Previous exposure with field sales organizations. Previous experience with copy writing/editing preferred

Customer & Industry Knowledge: Previous work in biotech or biopharmaceutical industry is mandatory Previous marketing agency experience is preferred

Education/Training: Bachelor degree in Marketing, Communications, Journalism preferred

Other Requirements: Excellent verbal and written communications skills. Strong initiative and ability to multi-task. Resourcefulness and ability to handle multiple tasks/initiatives with a high attention to

detail Ability to learn quickly and take on new challenges as they arise Strong team player who leads by example Change management skills

Company Description Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Additional Information Posted:March 5, 2013

3/17/2013 67

Type:Full-time Experience:Mid-Senior level Functions:Marketing Industries:Pharmaceuticals Job ID:4974409 ****************************************************** To apply: Visit http://tinyurl.com/b4ky8kr or www.BMRN.com Content Server Solutions Architect BioMarin- Novato, CA (San Francisco Bay Area) Job Description SUMMARY The Content Server Solutions Architect will have broad responsibility for BioMarin’s Enterprise Content Management platforms, including OpenText Livelink 9.7.1 and Content Server 10. This position is best suited for the person who thrives on new challenges and has the proven ability to make technology solutions work for the business challenges presented to IT by its clients. RESPONSIBILITIES • Architect, build, deploy and secure ECM solutions and equipment for internal customers. • Work with other ECM professionals to own, evangelize, and administer the ECM solutions used globally by BioMarin. • Develop, deploy, and maintain solutions in conjunction with business unit owners and cross-functional project teams. • Works with our external partners to manage operational issues of content management solutions, as well as being hands-on as required. • Understand business challenges and opportunities and drive new and innovative approaches to resolving them; Bridge the gap between business and technology to develop the right solutions for our clients. • Identify, recommend and implement technical solutions for application integration. • Deliver product, technology and/ or solution presentations to technical and business decision makers and engage interactively. • Lead and participate in project teams comprised of customers, partners, and peers from project inception through the hand off to operations as a technical subject matter expert. • Organize and lead user and technical requirements gathering and solution design sessions with customers, partners and other technical resources of all levels. • Practice disciplined execution focused on formulating solid vision, strategy, goals, and requirements collaboratively with customers and partners to ensure a well-defined opportunity with the right approach to executing on it. • Research and test emerging technologies to assist the business with developing strategic plans. • Provide ongoing systems support and enhancements once solutions are built and deployed. EDUCATION • BS/BA in related field or equivalent work experience. EXPERIENCE • 5-7 years related experience in designing, building and supporting advanced technical solutions on content management platforms. • Must be able to design and implement technical solutions to Enterprise business problems in a technology agnostic manner, but leverage existing platforms when it is the right choice to make. • Experience implementing and supporting Opentext’s document management system, Livelink/Content Server. • Must be able to think and deliver strategically while remaining proficient and engaged tactically with solutions. • Understanding of complex queries using Microsoft SQL.

3/17/2013 68

• Exposure to FDA or other regulated environments and ability to comply to such regulatory agency requirements. • Demonstrated ability to implement/upgrade/maintain systems within a rigorous change control environment. • Technical writing and verbal skills are required. • Candidate must be a strong team player recognizing personal improvement and awards are best achieved by making those around you successful. REQUIREMENTS • 2+ years in OpenText Content Server or Livelink development experience using Oscript, Workflows, Web/Live Reports, HTML, Java Script, Oracle PL/SQL • Impact analysis for upgrades, patches, and new enhancements • Familiarity with querying and organizing data using metadata • Development of LiveReports/WebReports •Experience with migrations, especially using 3rd party utilities such as Blubaker or Global Cents •Experience with any of the following: Livelink Builder, LAPI, OScript, Java, XML or Web services To apply: Visit http://tinyurl.com/b4ky8kr or www.BMRN.com Desired Skills & Experience EDUCATION • BS/BA in related field or equivalent work experience. EXPERIENCE • 5-7 years related experience in designing, building and supporting advanced technical solutions on content management platforms. • Must be able to design and implement technical solutions to Enterprise business problems in a technology agnostic manner, but leverage existing platforms when it is the right choice to make. • Experience implementing and supporting Opentext’s document management system, Livelink/Content Server. • Must be able to think and deliver strategically while remaining proficient and engaged tactically with solutions. • Understanding of complex queries using Microsoft SQL. • Exposure to FDA or other regulated environments and ability to comply to such regulatory agency requirements. • Demonstrated ability to implement/upgrade/maintain systems within a rigorous change control environment. • Technical writing and verbal skills are required. • Candidate must be a strong team player recognizing personal improvement and awards are best achieved by making those around you successful. REQUIREMENTS • 2+ years in OpenText Content Server or Livelink development experience using Oscript, Workflows, Web/Live Reports, HTML, Java Script, Oracle PL/SQL • Impact analysis for upgrades, patches, and new enhancements • Familiarity with querying and organizing data using metadata • Development of LiveReports/WebReports •Experience with migrations, especially using 3rd party utilities such as Blubaker or Global Cents •Experience with any of the following: Livelink Builder, LAPI, OScript, Java, XML or Web services To apply: Visit http://tinyurl.com/b4ky8kr 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

3/17/2013 69

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 Additional Information Posted:March 5, 2013 Type:Full-time Experience:Mid-Senior level Functions:Information Technology Industries:Biotechnology Job ID:5025073 ************************************************** Posted by Dave Catlin, Managing Director To apply, submit resume to [email protected] Clinical Trials Project Manager - Biologics The selected candidate will oversee the conduct of all clinical studies performed and ensure studies are completed on time within budget and in compliance with SOP’s, FDA regulations and ICH/GCP guidelines. You will work as part of a cross-functional team to ensure completion of the project clinical goals and act as a primary interface with the CRO. You will manage communications between monitors, clinical sites and the CRO including the implementation and execution of clinical programs, development and administration of site and vendor budgets. You will coordinate with non-project finance and project planning staff to ensure accurate allocation of expenses, accruals and resources. You will assist in the writing of protocols, the design of case report forms and other study documents as you work closely with external service vendors to oversee all aspects of the clinical trials. You will evaluate, tabulate and may prepare written summaries of clinical data. You will ensure compliance with protocol, overall clinical objectives and FDA/IHC requirements including conducting a review and source verification of clinical data to ensure timely resolution of data queries. Maintain contact with clinical investigators and staff and track all required site documentation. Qualifications include a BS/MS degree or equivalent in the life sciences, or a related technical degree with 8+ years of experience. Experience managing multi site trials, CRO’s and other vendors is required. You should also have experience in Clinical Trial Management, specifically demonstrating application of research methodology in a clinical trial setting. You should have thorough knowledge of GCP/ICH requirements and possess excellent oral and written communication skills. This position may supervise administrative support and other clinical

3/17/2013 70

staff and may be required to travel to clinical sites occasionally. This is a contract opportunity for approximately 6+ months in duration with the potential to convert to regular status. No relocation is offered for this position. ************************************************ For more information [email protected] Gastroenterology (GI) specialty Location: Southern California Working for a specialty therapeutics and diagnostics Company, this position will direct the clinical development and medical affairs functions for the GI diagnostics and therapeutic product lines. In addition, they will serve as an internal thought leader and spokesperson on any medical information and inquiries about the Company’s GI product lines. Requirements: MD degree; ten (10) years direct experience in gastroenterology (board certified not required); in depth experience with managing clinical trials; ability to deliver and express value to Key Opinion Leaders (KOL’s); demonstrated knowledge of medical affairs. ****************************************************** Send your resume at [email protected] Manufacturing Engineer with mechanical engineering degree Manufacturing Engineer (Medical Device) Title: Manufacturing Engineer with mechanical engineering degree Intanna Technologies Corporation is looking for Manufacturing Engineer with strong background in: 1) Design of Fixtures with Solidworks 2) Testing and validating parts and entire system with electronics inside (DVT and Validation). 3) System level experience in developing testing standards based on TUV, UL, FDA 4) Hands on person willing to work on the floor and participate for pre-production build 5) Analytical person who believes in statistical, six sigma and suggest clear path to launch products Requirement BS degree in Mechanical Engineering/Industrial Design/Manufacturing Engineering 5 to 8 years hands on exp. in product launch and manufacturing floor activities in medical device Hands on in product designing with plastics, sheet-metal and machined parts *************************************************

Jobs That Crossed My Desk Through March 3, 2013 ******************************************************* Interested Parties Please Contact: Katharine Rehahn Recruiter ICONMA 1.888.451.2519 Ext 111 [email protected] www.iconma.com http://bull.hn/l/119ZM/5

3/17/2013 71

I've got a great opportunity for a Jr/Mid Level Quality Engineer in Carlsbad CA. Please contact Katharine Rehahn at 888-451-2519 Ext 111 Know anyone for this job? Quality Engineer in Carlsbad, CA Quality Engineer Location: Carlsbad, CA Duration: 5-6 months Description/ Required Skills: - Tracks and initiates investigation of complaint trends. - Manages the Corrective and Preventative Action (CAPA) system. - Provides guidance for and assists with the process (re)validation activities. - Responsible for the implementation and management of the internal Quality Audit procedure and schedule. - Assures compliance to in-house and/or external specifications to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods. - Represents the site quality systems to customers in face-to-face meetings or through written and verbal correspondence. - May be required to perform other related duties as required and/or assigned. - Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. - Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. - Requires familiarity of c GMP.s and regulations applicable to the FDA. - Normally receives no instructions on routine work, general instructions on new assignments. - Requires strong, persuasive communication skills both verbally and in writing. - Work directly with Manufacturing teams on addressing product/process nonconformance’s, updating work instructions/SOPs, and manage CAPAs. - Ensure quality system protocols are being followed within the manufacturing process. - Update records as needed and prepare metrics for weekly review. Education: - Two plus year’s laboratory experience with a life sciences or medical diagnostics company. - Requires a Bachelors/Masters degree in molecular biology, chemistry, biochemistry, microbiology, engineering or related discipline. **************************************************** Posted by Jim Bishop, President and CEO - Bishop Executive Services LLC Dermatopathology Rep - Los Angeles Now hiring: Dermatopathology Rep - Los Angeles http://www.ziprecruiter.com/job/Dermatopathology-Rep-Los-Angeles/3b8ddba7/?source=social-linkedin-group-jobs ***************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=5009771&trk=eml-anet_dig-b_premjb-ttl-cn&ut=3Q5ErWgWTktBE1 For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com

3/17/2013 72

Regulatory Affairs Manager, Medical Device Pharmalink Consulting- San Francisco Bay Area Job Description • Offers strategic and operational regulatory support for identified medical devices projects involving in vitro devices, including PMA (Class III) devices. • In collaboration with management and regulatory project strategy teams, helps develop and review regulatory strategy for identified projects. • Interprets applicable regulations (21 CFR Part 820) and CDRH guidelines for project team use. Assists in keeping project team abreast of regulatory decisions, issues, potential problems, and new regulations. • Ensures timely submission of appropriate regulatory documents under direction of regulatory lead and in conjunction with Regulatory Operations. • Coordinates/solicits, reviews, and provides regulatory feedback on content of components for health authority submission from various functional areas. • Assists regulatory lead on assigned study teams to provide regulatory guidance on study activities. • Proactively raises major project issues to management for resolution and agreement. • Collaborates with other Regulatory Managers, and Regulatory Associates. • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses. Desired Skills & Experience Education & Experience Requirements • Bachelor’s degree is required in the scientific/health care field. • Experience with BLA submissions preferred, but not mandatory. • Possesses at least 7+ years of related experience within a medical device company, pharmaceutical company, CRO or similar organization and at least 4 years of direct experience with in vitro medical devices Key Skills and Competencies • Must be able to communicate comfortably and effectively with regulatory authorities. • Thorough knowledge of device design control and device regulatory submissions. • Proven ability to independently resolve problems. • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines. • Ability to work successfully within a cross-functional team. • Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. • Ability to work independently, take initiative, and complete tasks on deadlines. • Working knowledge of device filings including IDEs, PMAs and BLA filings. Company Description Pharmalink Consulting is the No 1 choice for sustainable outsourcing for all Regulatory Affairs requirements. We can resource any Regulatory Affairs project – regardless of size and

3/17/2013 73

timescale. From filing submissions to the more complex management of compliance issues and post-licensing activities, we are the experts in this field and can supply the market intelligence and consultants to match any Regulatory Affairs need – anywhere in the world. Unlike some other consultancies, Pharmalink specialises in Regulatory Affairs only. The business has become so specialised in the last 10-15 years, it requires dedicated teams of Consultants to meet the increasingly complex demands of local health authorities and keep abreast of all the changes that are constantly happening on a global and local market level. For additional information about the services offered by Pharmalink Consulting, please visit our website: www.pharmalinkconsulting.com Additional Information Posted:March 1, 2013 Type:Contract Experience:Mid-Senior level Functions:Consulting Industries:Pharmaceuticals Job ID:5009771 ******************************************************** Apply on company website for these Sterling Life Sciences positions To apply, please use this link: http://www.mybiotechcareer.com/JD/R-AND-D-Science-Engineering-General-Management-California-Biotechnology-Jobs-Careers-74416 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Clinical Program Manager Sterling Life Sciences - California (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/R-AND-D-Science-Engineering-General-Management-California-Biotechnology-Jobs-Careers-74416 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Oversee all trial operational aspects, including budgets, timelines, resources, vendor selection and clinical team staff during study start-up, interium monitoring and closeout activities 2) Manage multiple clinical trials 3) Manage one Anemia, Pre- Dialysis and Phase II global trial 4) Manage clinical study teams, CROs and vendors to ensure that the studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines 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,

3/17/2013 74

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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159174416 Job ID:5001135 ****************************************************** Apply on company website Medical Science Liaison (Hepatitis C) Boehringer Ingelheim - San Francisco (San Francisco Bay Area) Job Description The MSL I will function as a field based extension of Medicine serving as a liaison between Scientific Experts (SCEs) and BI Medicine in order to deliver scientific insights to the organization which address the scientific needs of the Hepatitis C Virus (HCV), Medicine colleagues, and influence strategic decision making and planning for compounds in development or products on the market. The MSL I will also function as an extension of the Medical and Technical Information (MTI) department in order to respond to HCP inquiries for scientific information and data. The MSL I will support the Clinical Development Medical Affairs (CDMA) HCV department including Scientific Affairs activities. At the direction of Clinical Operations, the MSL I may provide clinical trial support at various stages of a development program. The MSL I may provide scientific support, at the request of Commercial, for internal and external activities where there is a defined scientific role for Field Base Medicine (FBM). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and

3/17/2013 75

competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities:

The MSL I proactively interacts with SCEs within their assigned geography to support the Scientific Objectives (SOs) of the HCV Team. Through scientific exchange (SE), the MSL I will act as a scientific resource to SCEs and HCPs to answer specific questions on Hepatitis topics and BI compounds. The MSL I is responsible for establishing and maintaining scientific relationships with SCEs and having a strong understanding of the scientific landscape within their assigned territory. The MSL I will conduct SEs with SCEs, HCPs, as well as active and potential study investigators (BI-sponsored studies or IIS). The MSL I is responsible for providing field generated scientific insights regularly to FBM management.

The MSL I will provide scientific support for CDMA (BIPI & Corporate) and support Scientific Affairs activities such as Medical Grant Program Evaluations and Medical Publication Author Identification. The MSL I will also attend assigned scientific conferences, staff non-promotional Medical Information booths, as well as contribute to the development of the conference report.

The MSL I will adhere to all relevant BI policies and procedures and compliance expectations for FBM activities. The MSL I will incorporate ethical decision-making into all business practices.

The MSL I will maintain clinical, scientific, and technical expertise in specific TA through continuous learning and knowledge of the Hepatitis related scientific literature.

Desired Skills & Experience Doctorate degree (PharmD, M.D., DO, Ph.D.) with 1 or more years of relevant clinical or

therapeutic area experience in Hepatitis. Masters level degree in health sciences with 3 or more years of relevant clinical or

therapeutic area experience in Hepatitis. Previous MSL experience desired. The position is field-based with upwards of 75% required travel (car, train and plane) to

manage assigned geography. Easy access to large hub airport desired. Ability to use field-based electronic or other communication tools for all aspects of job is

critical, as well as the ability to maintain excellent relationships with scientific experts and health care providers.

Company Description The objectives and beliefs of Boehringer Ingelheim can be summed up in a single phrase: Value through Innovation. This vision has helped us build on our strengths and make the most of our distinctive character for over 125 years. Value through Innovation is what drives us to continuously search for new and innovative ways to bring more health to the lives that we touch - whether that be lives of patients and their families, our employees or our community. Boehringer Ingelheim is committed to furthering science that benefits the health of patients and their families. Over the years, we have brought a range of successful products from drug discovery to market. Learn more about successful products from our own Research & Development as well as examples of promising compounds in our pipeline by visiting: http://www.boehringer-ingelheim.com/research_development/drug_discovery/pipeline.html Boehringer Ingelheim is a globally operating group of companies with 138 affiliated companies worldwide and nearly 43,000 employees worldwide. Our business areas Our Human Pharmaceuticals business area covers the segments: • Prescription Medicines • Consumer Health Care • Biopharmaceuticals • Operations (Pharma Production and Chemical Production) In Animal Health, our core business segments serve food-producing and companion animals. Additional Information Posted:March 2, 2013 Type:Full-time

3/17/2013 76

Experience:Mid-Senior level Functions:Other, Science Industries:Pharmaceuticals Employer Job ID:130683 Job ID:5011526 ______________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Clinical-Research-Affairs-California-Biotechnology-Jobs-Careers-74698 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Clinical Research Associate / CRA Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Monitor one or more clinical trials 2) Participate in the design and writing of protocols, case report forms and informed consent forms for all clinical trials 3) Initiate and coordinate study start-up activities, including investigator identification and selection, contract and budget preparation, presentation at investigator meeting and vendor/investigator training 4) Take responsible for study management, including CRO, central lab and vendor management 5) Collect documents and generate supplemental material, including monitoring plans, data management plans and training materials 6) Ensure site evaluations, investigator meetings, study initiation, monitoring, closeout visits, review of case report forms, adverse event recording and reporting 7) Manage and ensure that the studies are conducted and adhere to FDA/ICH guidance on Good Clinical Practices (GCP) 8) Monitor investigator performance and ensure protocol compliance and patient safety 9) Ensure that Case Report Forms (CRFs) are reviewed, pulled in a timely manner and submitted to Data Management 10) Assist in writing and compilation of the clinical report for submission 11) Coordinate clinical supply requirements, shipping and key documentation with global R&D locations 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:

3/17/2013 77

http://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Project Management, Research, Science Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159174698 Job ID:5001134 ______________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Regulatory-Affairs-California-Biotechnology-Jobs-Careers-84415 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Regulatory Affairs Associate / RA Associate Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Assist in reviewing and maintaining documentation associated with manufacturing and vendor qualifications 2) Coordinate and support the development of the finished product stability program 3) Assist in maintaining the R&D database 4) Represent R&D by offering technical assistance to multiple groups within the company, including quality control 5) Oversee regulations, research and current events in regards to product labels, product claims and nutritional values, and material issues 6) Maintain up-to-date knowledge of laws, regulations and policies enforced by the federal, and the state governments 7) Author submissions and other regulatory documents to obtain approval to bring new or modified products to market TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine,

3/17/2013 78

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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 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:11159184415 Job ID:5001119 _____________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Quality-R-AND-D-Science-Laboratory-California-Biotechnology-Jobs-Careers-87456 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Sales Account Manager, Lab equipment ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Grow new accounts, identify new opportunities and build relationships to gain new business revenue for the company 2) Implement effective sales plans to position the organization competitively and meet / exceed territory objectives 3) Identify the needs of new prospects and develop appropriate responses

3/17/2013 79

4) Perform field calls for the account and assigned territory 5) Participate and attend sales meetings and professional association meetings outside of regular business hours, as required 6) Build and maintain key alliances with distributors and field sales team 7) Communicate with all levels of management within both the distributor and field sales organization 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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:March 1, 2013 Type:Full-time Experience:Mid-Senior level Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11159187456 Job ID:5001094 *********************************************************

3/17/2013 80

Meredith McClanahan Recruitment Services Specialist at BioPhase Solutions LocationGreater San Diego AreaIndustryStaffing and Recruiting http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=2830 Scientist Engineer BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Scientist Engineer to work for a leading Bay Area biotechnology company. BioPhase Solutions is recruiting for a Scientist Engineer in Signal Processing and Algorithm Development for Next Generation Sequencing. This is a direct-hire full time position with our exciting start-up client located on the San Francisco Bay Area Peninsula. In this role, you will be a key player in the development of DNA Sequencing technology for healthcare and diagnostics. __________________________________________ Regulatory Affairs (Orange County, CA) BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for Regulatory Affairs professionals to work for a leading Orange County Medical Device company. http://www.biophaseinc.com/viewjob.php?jc=j_cli&rec=252 _____________________________________________________ http://www.biophaseinc.com/viewjob.php?jc=j_cli&rec=251 Sr. Regulatory Affairs Associate (fluent in Japanese) BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Sr. Regulatory Affairs Associate to work for a leading Bay Area biotechnology company. BioPhase Solutions is recruiting for a Senior Regulatory Affairs Specialist with language skills in Japanese for our major medical diagnostic client located in Santa Clara, CA. This is a full time direct-hire career opportunity. ****************************************************** Posted by Whitney Hood Recruiting Consultant at Real Staffing San Francisco Sr. R&D Engineer Real Staffing Group- Irvine, CA (Orange County, California Area) Job Description R&D Project Engineer. This position is responsible for the research, design, and development of endovascular delivery systems and implantable medical devices for the treatment of peripheral and cerebrovasculature diseases Major Responsibilities: • Establishing product customer requirements, concept prototyping, conducting and overseeing product testing, design and development (including verification and validation), material selection, risk/failure mode assessment,

3/17/2013 81

performance and safety. • Develop and validation of test methodology • Interfacing with Physicians • Perform pre-clinical in-vitro and in-vivo testing • Assisting with pilot-production and post production GMP compliance • May directly supervise one or more technicians • Complete documentation of all project data (responsibility to assure accuracy and completeness) • Comply with applicable FDA / ISO13485 Job Requirements: Education/Experience: • Bachelors degree in Mechanical Engineering or similar field with 5+ years direct experience or Masters with at least 3+ years experience is required. Minimum of three years of experience in catheter design. Skills and Experience: • Extensive experience in the mechanical design and testing of medical products - specifically disposable catheter systems. • Catheter and medical implantable device experience including writing protocols and reports to support verification and validation activities for product commercialization. . • Minimum 5 years in medical device development. • Computer skills, to include spreadsheets, word processing, project scheduling, AutoCad, Solidworks • Working knowledge of FDA/GMP and ISO regulations (Design Controls). • Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports. • Strong, team-oriented professional with good interpersonal skills and project management experience. • Timeline and budget development and management • Independent self-starter requiring minimal daily supervision Salary: $90K to $125K + bonus, equity, benefits etc depending on experience. Location: Santa Ana, CA Company Description Real Staffing is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services and has one of the largest networks of specialist recruiters globally. Our premise is a simple one: by recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time. At Real Staffing we offer retained search as well as contingency recruitment within both the contract and permanent markets. Our consultants are market specialists and it is this in-depth market knowledge that allows our consultants to develop tailored recruitment solutions for this demanding recruitment market. We take the time to understand our candidates' current and future ambitions and actively seek out roles that will help take our candidates to the next level in their career. The strength of our client relationships and global network means we can access the best new roles within the sector. Whether you are looking to strengthen your team or looking for your next career move contact

3/17/2013 82

us today. www.realstaffing.com Additional Information Posted:February 27, 2013 Type:Full-time Experience:Not Applicable Functions:Project Management, Manufacturing, Business Development Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:$90K to $125K + bonus and equity package Job ID:4986609 ************************************************** Posted by Stan Cross, Clinical, Scientific and IT Recruiter http://bull.hn/l/1188J/3 HR Associate | San Carlos, CA Hiring a Human Resources Associate in San Carlos, CA looking for a HR Associate for a short term contract position in San Carlos, CA. The Human Resources Associate is responsible for providing confidential administrative, operational and project support to the Human Resources Team; responds to managers and associates requests for HR materials, job information, and route to appropriate resource or other HR colleague as required. •Serves as initial contact person in the Human Resources Department, providing direction on site policies, practices and procedures. •Participates and assists with department projects and activities as requested; works with HR staff on implementation of new programs/procedures or to solicit assistance in the resolution of a HR related issue; researches and compiles information for special projects as needed; and look for opportunities to enhance the effective of site HR delivery systems. •Coordinates and schedules meetings, interviews, appointments, etc. •Prepares and ensures appropriate materials are available. Creates overheads for presentations using presentation graphics software as requested. Writes, edits and proofs correspondence, reports, memos, etc. •Maintains files and records for Human Resources. Maintains, data enters and ensures the accuracy of information into assigned department databases and spreadsheets. Requirements •2-5 years in a Human Resources experience. •Complete understanding and use of human resources planning concepts/principles. •Full knowledge of pharmaceutical industry practices. •Ability to handle multiple projects and activities and work under pressure. •Demonstrated ability to work with limited daily direction; and able to exercise considerable initiative to provide a variety of advanced analytical and general HR administrative tasks. •Proficiency with word processing, spreadsheet and presentation graphics software. Microsoft Word, Excel, PowerPoint, and Outlook preferred. •PeopleSoft, applicant tracking system (BrassRing) or other HRIS systems experience highly desirable. ____________________________________________________

3/17/2013 83

http://bull.hn/l/11HLV/6 Sr. HR Rep | Brea, CA Are you a good fit for this job? Sr. Human Resource Representative in Brea, CA The Human Resources Manager will design, implement, and support strategies and programs to enhance the effectiveness of managers and the productivity and satisfaction of employees at the Brea site. The incumbent will optimize relationships between employee and employer; link human resources strategies to business objectives: ensure compliance with all labor laws; counsel and advise management on a variety of topics related to human resources and design and implement training, performance management, and organizational design programs. Drives and manages Workforce Planning and Headcount management Provides consultation and training on Engagement & Retention of associates Drives and manages Performance Mgmt processes including coaching leaders on tough conversations, co-creating performance improvement plans and ensuring leaders are following through with the annual process. Consults with clients on internal movement decisions; transfers, promotions, job enhancements and ensures decisions are in line with company policy and leveling guides. Conduct Employee Relations investigations and consult with managers and ER counsel on outcomes and next steps. May co-facilitate training and development programs. Delivers change management consultation to clients Reports monthly metrics to HR leadership and drives to ensure that countermeasures are in place when not hitting targets. ] Consults with leaders on talent management and organizational design challenges. Job Requirements Include • BA with an average of 9+ years of HR experience with 2+ years as a generalist or MA with an average of 7+ years of experience as a junior business partner or field generalist • Solid and sophisticated skills in: consulting, contracting, mediating, negotiating, coaching • Experience in compensation, recruiting, employee relations, organizational development is preferred (ideal mix 2 or more areas) • Working knowledge of employment law including Title VII, ADA, ADEA, FMLA, FLSA, OSHA and Workers Compensation • Thorough and deep knowledge of the employee life cycle • Has had experience leading or contributing to small to medium scale re-orgs, org alignment, workforce planning efforts • Has had previous experience managing complex and cross-functional initiatives, processes, or projects • Exposure to and comfort with higher management ************************************************* Posted by Darshana Nadkarni, Ph.D. For the opportunity below, please send resume to wd_darshana at hotmail dot com. Prototype Hardware/Firmware Design Engineer - SF, CA Other opportunities are posted in JOBS category at the link below. Prototype Hardware/Firmware Design Engineer - SF, CA There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in

3/17/2013 84

design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus. Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology. Darshana Varia Nadkarni's Blogdarshanavnadkarni.wordpress.com Jobs in Biotech & Medical Device... ********************************************** Posted by Jeff Randles, Account Manager - Sr. Recruiter at Precept Life Sciences Contract Regional CRA in Los Angeles, CA Now hiring: Contract Regional CRA in Los Angeles, CA http://www.ziprecruiter.com/job/Contract-Regional-CRA-in-Los-Angeles-CA/bd74e788/?source=social-linkedin-group-jobs ************************************************ Posted by Shantanu Lajmi, Entrepreneur ★ Founder ★ rawDATAjobs.com ★ practiceHRM.com ★

SEEKING 'DATA ANALYTICS' professionals in USA with 2-4 yrs work exp, RECRUITMENT DRIVE @ Los Angeles, CA-Saturday, 9th March 2013. Interviews & Spot offers! (H1B/OPT/EAD/GC/USC) http://lnkd.in/X2TpqT Data Analytics professionals across domains (some experience in PHARMA domain preferred/not mandatory) for SF Bay Area, California, USA. Please email CVs to: [email protected] Position: ASSOCIATE - Analytics (Full-time/Permanent)rawdatajobs.com Job Location: San Francisco Bay Area, CA (Interviews on Saturday- 9th March, 2013 , Spot offers for selected Candidates!) Our Client is an 'award-winning' pure-play Analytics and decision sciences organization, based out of USA... ****************************************** Posted by Isabel Brito, Atlantic Management Resources Send resumes to [email protected] We're looking for sales in Central LA. We're looking for strong pain sales reps with excellent hospital experience (a must) in Central LA. This is a great opportunity to work for a small, growing pharma company. ************************************************ Started by Venkat Giri, Clinical & Scientific Recruiter at Makro Scientific

3/17/2013 85

Apply Online http://www.wisestep.com/ROFQSOOQ/IRDGFKEFJE or Refer Friends who will love to take it. Hiring for Associate Scientist I at Foster City, CA and is looking for suitable candidates. I am using wisestep.com to share my jobs on Multiple Linkedin Groups with a single click. Job Description: Makro Scientific: Life to Life for Better Life. Makro Scientific: Staffing Specialist in Clinical and Scientific. Job ID : LVG-31167 Job Title : Associate Scientist I Duration : 10/31/2013 Location : Foster City, CA Duties: Conduct pre-designed scientific or engineering experiments using laboratory equipment and calculations. Verify and validate product design and performance during the development cycle, from feasibility through product release. Products include benchtop instruments, sample preparation, synthetic biology, protein expression, protein analysis, and enzymes. Plan the use of equipment, materials and own time. Assist in lab procurement, calibration or maintenance of equipment. Make detailed observations and basic data analysis. Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. Suggest options /ideas for additional experiments. Troubleshoot experiments with assistance from supervisor. Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment. With supervisors guidance, become familiar with literature directly associated with assigned project and transmit information gathered to other members of the scientific team. Maintain complete and thorough lab notebook and training file in accordance with division standard. Comply with all company safety regulations and procedures. Position exercises judgment within defined procedures and practices to determine appropriate action. Normally receives general instruction on routine work, detailed instruction on new assignments. Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. Works on problems where analysis of situation or data requires a review of identifiable factors. Accuracy is required in performing all functions of this position, mistakes in work could cause substantial interpretive errors. May be required to perform other related duties as required and/or assigned. Main duties would include, but may not be limited to: Running tests and experiments in the laboratory. Preparing PCR reaction plates and running on AB qPCR systems. Contributing to writing and executing test plans and reports. Executing statistical data analysis. Major responsibilities are understanding and executing procedures, accurately recording data, and assisting in data analysis. Skills: Experience working in a lab environment and familiarity with basic laboratory practices a must. Good communication skills and experience developing testing, measurement and characterization methods are desired. Familiarity with proper documentation practices and technical writing experience, including creating test protocols and SOPs is desired Experien ********************************************************** Senior Consultant – Rachel Riley, [email protected] Clinical QA Consultant Real Staffing Group- San Francisco Bay Area Job Description Clinical QA Consultant A pharmaceutical company in the Palo Alto, CA area is looking for a Clinical QA Consultant to join their team. This is an excellent opportunity to join a start-up with an exciting pipeline. Clinical QA Specialist Overview: Provides critical direction, documentation, deliverables, assistance and support for all quality control compliance functions related to Good Clinical Practice (GCP) for clinical development activities. Ensure high level GCP compliance, documentation and adherence to company’s and external partners SOPs. The position requires a strong working knowledge of FDA regulations and guidance documents, International Conference on Harmonization guidelines and cGCP guidelines. Through proactive and comprehensive compliance initiatives directed by the Clinical Compliance Specialist, the company’s clinical development activities will be conducted at a very

3/17/2013 86

high level consistent with GCPs with robust documentation to provide confidence and assurance in all clinical data and results generated. The Clinical QA Specialist will have the following responsibilities and roles:

Clinical SOPs, processes –development, revision, training and implementation of required SOPs

Oversight and accountability for compliance within the Clinical Department with internal SOPs, process, and regulatory requirements by:

Identifying process gaps Performing internal process assessments of clinical operations and or documentation Effectively documenting process improvements to demonstrate due diligence with

proactive compliance Identifying the critical components to achieving increased clinical compliance through a

risk-based approach Identify and development of specific tools, critical documents needed to track

compliance, and processes to enable proactive and systematic detection, analysis, remediation and prevention of compliance quality issues/risks

Identifying useful indicators for assessing compliance for ongoing performance of clinical vendors

Evaluating performance indicators tracked to ensure GCP compliance is maintained and to alert management of potential non-compliances

Effective strategies for tracking and recording changes to study documentation Participate in end of study documentation compliance reviews including data set review,

Tables, Listings and Findings, CSR, Trial Master File reconciliation Serve as Clinical interface with Topica’s Quality Assurance Group for all GCP internal

and external audits and CAPA. Some travel may be required to key clinical vendor sites and clinical research sites.

Desired Skills & Experience Clinical QA Specialist Requirements:

Minimum BS or equivalent and minimum 10 years clinical research experience in a pharmaceutical/biotech company working within clinical compliance, process improvement, and/or risk management

Proven ability to work independently, efficiently and effectively Effective communication and time management skills critical to achievement of QC

goals; Good working knowledge of clinical development software (IWRS, Rave, MS Office etc.); Familiarity with an outsourced clinical trial model; Ability to represent Topica effectively with CRO and key external vendors, and; Excellent documentation skills and systems design.

If you are interested in this position, please respond to this job positing ASAP. 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

3/17/2013 87

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. 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:February 28, 2013 Type:Contract Experience:Director Functions:Quality Assurance Industries:Pharmaceuticals Job ID:4988803 ******************************************************** Posted by Craig Charyak, Talent Manager Please send resume to [email protected] and/or call (415) 374-8872 R&D Partners is seeking a Cleaning/Equipment Validation Engineer for a 12 - 18 month project in San Diego, California . Cleaning/Equipment Validation Engineer in San Diego, CA R&D Partners is seeking a Cleaning/Equipment Validation Engineer for a 12 - 18 month project in San Diego, California . Please send resume to [email protected] and/or call (415) 374-8872 See below job description Responsible for generating, executing, and finalizing equipment, IQ,OQ,SIP and cleaning validation. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site. Working closely with Engineering, MSAT, Quality Assurance and Manufacturing. requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams. Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).

3/17/2013 88

Generation of Tracability Matrix Participate in cross-functional team meetings and where required Sound knowledge and understanding of GMP guidelines, USP, and CFRs applicable to the pharmaceutical/biotechnology industry. Skills: -Ability to manage technical projects through to completion to achieve results. -Logically and methodically works through complex problems to identify root causes and provide rational solutions. -Proven effective verbal and written communication skills. -Delivers results -Understands the validation process and recognizes supplier limitations and customer expectations. -Accountable for projects, and communication. -Seeks guidance and support when required. Education: Bachelor's Degree Required http://bull.hn/l/11ESW/1 ******************************************************* Posted by Kendra Bullock, Researcher - Northeast Region at inVentiv Health Email [email protected]. Looking for Part-Time Pharmaceutical Sales? Do you live near Riverside, CA, Las Vegas, NV, San Francisco, CA or Dallas, TX? ******************************************************* https://jobs.smartbrief.com/action/listing?listingid=301FF649-3812-4CDC-A0EE-223AB40A20F6&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7%25252db8c8%25252d41a0%25252d9df0%25252d199b99dc80c0 REGULATORY AFFAIRS SPECIALIST Masimo Corporation Job Description Masimo (NASDAQ: MASI) headquartered in Irvine, California, is a fast-growing and award-winning international medical technology and device company with operations spanning the globe. We develop innovative, noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. These revolutionary technologies are helping to solve "unsolvable" problems that have plagued the healthcare industry, while taking the pain and discomfort out of blood monitoring. For more than 20 years, innovation has been and will continue to be our passion. To learn more about us, please visit: www.masimo.com Job Summary: In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an

3/17/2013 89

expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations. From coordinating with international regulatory team members on product changes to maintaining up-to-date information on domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent’s medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people’s lives. Duties & Responsibilities:

Support the regulatory team managing international and domestic filings/registrations; Coordinate with international regulatory team members on product changes and

regulatory notification / approval requirements; Assist in maintaining product list on Certificate of Foreign Government; Maintain up-to-date knowledge on international and domestic regulatory requirements; Generate and maintain product compliance checklists; Provide regulatory support to the OEM Deployment group; Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports; Submit document change orders (DRO/agile) for approvals; As requested by supervisor, represent RA department in project meetings and provide

regulatory guidance;

Update RA responsible quality system procedures as required (SQP/SOP’s); Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience: Minimum Qualifications: Computer Proficiency with MS Office (Word/Excel/Access/Outlook);

Excellent verbal and written communication skills; Excellent prioritizing, organizational, and interpersonal skills; Excellent documentation skills including record maintenance/tracking and understand

document traceability; A detail-oriented individual with a “can do” attitude; Ability to work in a team environment as well as individually with minimal supervision; Ability to work in a fast-paced , Project Team environment, with multiple

tasks/projects; Preferred Qualifications:

Some previous work experience in a medical device Class II/ III environment; Experience in patient monitor systems, hospital-based products, software or electronic

device products; Knowledge of regulatory submission requirements for FDA Class II medical devices, and

equivalent classification requirements for international submission; Experience with FDA/GMP requirements for medical device; Experience in Quality Systems, per ISO 13485;

3/17/2013 90

Experience with the UL/ETL certification process;

Experience interacting with regulatory bodies, such as the Notified Body; Education: High School or GED is required. Some college level coursework is preferred. BA/BS Degree is a definite plus. Physical requirements/Work Environment This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described. Masimo is proud to be an EOE, M/F/D/V, and we value and are committed to Diversity at every level. ******************************************************************************************************* Posted by Meredith McClanahan, Recruitment Services Specialist at BioPhase Solutions Contact [email protected] if interested! Management Leader in Sequencing Technology BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Management Leader in Sequencing Technology to work for a leading Bay Area biotechnology company. Management Leader in Sequencing Technology BioPhase Solutions is recruiting for a direct-hire full time employee for our exciting start-up client located on the San Francisco Bay Area Peninsula. In this role, you will be a key player in the development of DNA Sequencing technology for healthcare and diagnostics. This is a leadership role at the Director to Sr. Vice President level. Responsibilities will include: Lead a team in biology, chemistry, and sequencing to include chemistry, sample preparation, and applications. Design and analyze experiments. Collaborate closely with scientists and engineers working on development of signal processing, bioinformatics, sensor technology and instrumentation. Establish and manage relationships with early-access collaborators; and help to identify optimal early applications for sequencing technology.

3/17/2013 91

Requirements: PhD in chemistry, biology, or equivalent, with 10+ years of biotechnology industry experience. Experience with Next Generation Sequencing technologies, sample preparation, and applications required. Experience with assay development and/or life science instrumentation product development. Ability to have productive collaborations within a multidisciplinary environment. Excellent communications skills – ability to speak clearly about the technology both internally and externally. Proven ability to drive new technology forward at a rapid pace. Strong analytical skills. Familiarity with bioinformatics and data analysis methodologies. Experience building and leading strong, talented teams of scientists. Be sure to visit http://www.biophaseinc.com to view all our latest job opportunities. ________________________________________________________ Bioconjugation Scientist BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Bioconjugation Scientist to work for a leading Bay Area biotechnology company. Bioconjugation Scientist This is a temporary position located in Fremont, CA, supporting our growing medical diagnostics client. In this role, you will be working with a team of scientists, engineers and manufacturing personnel in the development and scale-up of cell-based diagnostic devices; and assist the R&D team in the development and optimization of bead based reagents, manufacturing and QC. http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=2822 **************************************************** Posted by Jennifer Harvey, HR Business Partner at Veracyte Reimbursement Specialist - Temp (Possible Temp to Perm) Now hiring: Reimbursement Specialist - Temp (Possible Temp to Perm) http://www.ziprecruiter.com/job/Reimbursement-Specialist-Temp-Possible-Temp-to-Perm/7938e3e6/?source=social-linkedin-group-jobs _________________________________________________ Clinical Trials Manager Now hiring: Clinical Trials Manager http://www.ziprecruiter.com/job/Clinical-Trials-Manager/e25f445c/?source=social-linkedin-group-jobs ******************************************************** http://www.linkedin.com/jobs?viewJob=&jobId=4963354&trk=eml-anet_dig-b_premjb-ttl-cn&ut=0AqyRhzJ_UmlE1 Associate Director/Director of Regulatory Affairs (Clinical Development) Real Staffing Group- San Francisco Bay Area Job Description Associate Director/Director of Regulatory Affairs (Clinical Development) A small to medium sized pharmaceutical company in South San Francisco is looking for an Associate Director or Director of Clinical Regulatory to join their team. This is an excellent

3/17/2013 92

opportunity to join growing a company with a product out in Canada and the EU and looking to get their drug approved in the US. Summary: Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate. Duties and Responsibilities:

Responsible for contributing to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).

Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.

Represent regulatory on relevant project teams. Mentor other Regulatory staff members. Identify/assess and timely communicate regulatory risks for assigned projects or

programs. Prepare and deliver effective presentations for external and internal audiences, as

required. Interact with regulatory agencies relevant to assigned projects or programs, as

appropriate. Contribute to life-cycle management of products. Ability to work both independently with minimal direction and within project teams,

committees, etc. to attain group goals. Desired Skills & Experience Qualifications:

Minimum 8+ years in Regulatory Affairs Experience in providing regulatory support for all phases of clinical development. Experience with multipleINDand CTA filings and maintenance Experience and knowledge in the preparation of major regulatory submissions (NDA,

NDS, or MAA) and supportive amendments or supplements. Demonstrated excellent communication skills. Demonstrated strong organizational skills, including the ability to prioritize personal and

direct reports workload. Strong interpersonal skills and the ability to deal effectively with a variety of personnel

including medical, scientific, quality and clinical supply/manufacturing staff. Experience in interfacing with relevant regulatory authorities Experience in interpretation of regulations, guidelines, policy statements, etc. Experience working on products in development specifically relating to clinical and pre-

clinical regulatory aspects of the project. Good knowledge of GCPs and GLPs. Demonstrated effective cross-cultural awareness and capabilities.

Education: BA/BS/University degree required, Life/Health Sciences preferred. 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:

3/17/2013 93

- 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. 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:February 25, 2013 Type:Contract Experience:Director Functions:Quality Assurance Industries:Pharmaceuticals Job ID:4963354 ********************************************************** To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-87928 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Director of Sales ( Business Development ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Responsible for representing all company products, maintaining base business, acquiring new business and meeting or exceeding annual sales goals. 2) Maintain call frequencies at hospitals, laboratories and physician accounts. 3) Represent the company to the customer in a manner that demonstrates the highest degree

3/17/2013 94

of integrity. 4) Attain a practical understanding of company products, methodologies and competition. 5) Utilization of good selling skills that allows for the identification of need and presentations based upon identified need. 6) Completion of tenders and presentations within assigned territory. 7) Have good understanding and working ability in Microsoft programs. 8) Strong relationship building skills with customers, vendors and co-workers. 9) Prompt reporting of competitive information and updates as to existing market conditions. 10) Update and adjustment of current customer base pricing. 11) Aid in the training and development of new sales employees. 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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Director Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151187928 Job ID:493507 __________________________________________

3/17/2013 95

VP of Regulatory Strategy and Product Development Sterling Life Sciences - California (San Francisco Bay Area) Job Description To apply, please use this link: http://www.mybiotechcareer.com/JD/R-AND-D-Science-Engineering-Product-Management-California-Biotechnology-Jobs-Careers-87978 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Contribute to the development and implementation of procedures and policies for regulation of marketed promotional materials 2) Develop strategies for regulatory approval and introduction of new products to market 3) Manage the process from development of regulatory strategies through to approval 4) Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval 5) Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards 6) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements 7) Establish appropriate risk analysis activities which include the use of risk analysis tools 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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted.

3/17/2013 96

Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Executive Functions:Science, Project Management, Quality Assurance Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151187978 Job ID:4935064 ___________________________________________________ To apply, please use this link: http://www.mybiotechcareer.com/JD/Sales-Marketing-California-Biotechnology-Jobs-Careers-88545 or you can email resume to: [email protected] (NO PDFs please - we prefer MS-WORD or plain text) Vice President of Business Development ( Sales ) Sterling Life Sciences - California (San Francisco Bay Area) Job Description Tip: If you apply using the link above, your resume will be reviewed faster because it will go to the Lead Recruiter. 1) Initiate marketing strategies and co-ordinate actions to influence the market 2) Clarify goals and reach agreement maintaining the interests of all parties 3) Proactively develop and improve products and services 4) Build and maintain excellent relationships with colleagues and clients 5) Set sales targets and define strategy to achieve these targets and to follow the set strategy punctually 6) Manage the proposal development process and maintain the time-lines for the proposal teams 7) Co-ordinate with sponsors concerning size, standards, conditions and timing of research 8) Develop draft proposals based on team meetings and discussions 9) Maintain the business development databases 10) Support marketing activities, including trade / scientific shows, mailings, etc. 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,

3/17/2013 97

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://www.mybiotechcareer.com/sterling-hoffman-jobs-in-biotechnology-pharmaceutical.cfm 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). You are also welcome to join his network on LinkedIn: [email protected] - your invitation will be accepted. Remember: to apply for a position, use the LINK provided in the description (or click the 'APPLY' button on LinkedIn and follow the steps). It is much faster to apply it is best to use the link we provided above for quick review of your credentials. Tip: don't upload PDF resumes - they are hard for our system to manage. It's best to upload a plain text or MS-WORD resume. Additional Information Posted:February 21, 2013 Type:Full-time Experience:Executive Functions:Sales, Business Development, Marketing Industries:Biotechnology, Pharmaceuticals, Medical Devices Compensation:Superb. Commensurate w/experience. Employer Job ID:11151188545 Job ID:4935057 *************************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** 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

3/17/2013 98

*************************************************************** 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: 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

3/17/2013 99

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 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.

3/17/2013 100

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.

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

3/17/2013 101

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 [email protected], 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” • [email protected] 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.” 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.

3/17/2013 102

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 [email protected]. 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/ 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.

3/17/2013 103

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 [email protected] if they wish to receive these mailings directly. *************************************************************************

Date post:	05-May-2019
Category:	Documents
Upload:	vuonghuong
View:	214 times
Download:	0 times

JobsThatCrossedMyDesk March 17, 2013 - Audrey' s Network file3/17/2013 · Jobs That Crossed My Desk...

Documents