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Jobs That Crossed My Desk Through Dec. 8, 2013 Complimentary Service of Audreysnetwork.com

Dec. 8, 2013

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

Manager/Sr. Manager Regulatory Operations - San Francisco, CA Medivation - San Francisco, CA Posted 6 days ago

Job description Manager / Senior Manager, Regulatory Operations Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Manager / Sr. Manager, Regulatory Operations reporting to the Associate Director, Regulatory Affairs. Essential duties and responsibilities include but are not limited to the following: Incumbent will oversee a team responsible for producing, tracking and prioritizing Medivation regulatory submissions and submission-compliant documents to a variety of regulatory authorities, CROs and Strategic Alliance Partners. • Responsible for authoring, implementing and maintaining various departmental guidelines, procedures and templates as well as providing training to departmental and external resources • Evaluate and recommend new department technologies and collaborate with intra-departmental resources to ensure adherence to infrastructure standards Requirements: • Minimum 5 years relevant experience in the pharmaceutical industry, including submissions of original eCTD NDA and IND applications • At least 2 years experience leading and mentoring a staff of Regulatory Operations publishers • Expert-level proficiency in all Regulatory Operations technical technologies tools, including: At least

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one industry standard eCTD building system in a Part 11 validated environment, MS Word, Acrobat Professional, ISI Toolbox Ability to troubleshoot using these systems is vital • Ability to communicate effectively with a variety of corporate stakeholders and external vendors • Detail oriented • Excellent copy/editing and language skills • High familiarity with relevant industry guidance and regulations and ability to ensure departmental output consistently meets these standards • Ability to prioritize multiple projects • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) • Experience in implementing Part 11 validation protocols and use of FDA’s Electronic Gateway is a plus Education: • Bachelors degree desired Note: Internet Explorer is required to apply to positions. You may email your resume to hrpostings@medivation.com, if you do not have access to Internet Explorer. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V

Apply on company website

Manager, IXRS Onyx Pharmaceuticals, Inc. - South San Francisco, CA, US Posted 11 days ago

Job description The IXRS Manager will manage all aspects of the Interactive Voice/Web Response Services (IXRS) in support of Onyx clinical trials. Responsibilities will include standardizing workflow processes and standards and ensuring adoption across the organization and with business partners. The IXRS manager will define preferred vendor criteria, select preferred vendors and define metrics to measure vendor performance. The IXRS Manager will define business requirements for IXRS systems provided by vendor, assist with system design, and define acceptance criteria. The IXRS Manager will also be responsible for system implementation, adoption and maintenance, and IXRS vendor management in collaboration with cross-functional Study Execution Team (SET) members.

Collaborates with Clinical Operations Management and SET members to determine if an IXRS is required to support a clinical trial, and participates in the identification and selection of an IXRS vendor, including the development of a RFP, review of competitive bids, and participation in potential vendor audits

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Oversees, authors, reviews and approves IXRS study user requirements and system specification documents

Facilitates the review and approval of the final User Acceptance Testing of the IXRS application; works with cross-functional groups to ensure the appropriate testing and feedback is performed and captured

Supports study teams; works with the IXRS Vendor, Supply Chain, QA, and the Study Leads/CROs to resolve IMP issues at investigational site(s) globally, and contributes to and reviews vendor corrective/preventive action plan(s), as appropriate

Conducts specification and user acceptance testing activities for data feeds from IXRS and CRO vendors into the Clinical Trial Management System (CTMS), and other system integration activities

Supports process development efforts; develops IXRS processes, tools and standards, performs IXRS issue tracking and metrics analyses, and creates dashboards to track vendor performance

Collaborates with Global and Regional Study Leaders to evaluate, develop and/or select appropriate IXRS vendor reports, including but not limited to:

High-level, management dashboards for effective management of patient recruitment and Investigational Medicinal Product (IMP) supply management, including drug accountability and reconciliation

Reports to manage the operation of IXRS data feeds into CTMS and other systems as appropriate Detailed, working reports to enable study managers to manage patient recruitment and assist in

overall management of IMP; from initial authorization-to-ship to expiry date management and destruction

Supports vendor management activities, including regular business reviews, vendor contracts, and overall partnership management

Collaborates with Biostatistics on the generation of study randomization schemes, and with Statistical Programming and Clinical Data Management on data transfer methods

Education/Training:

BA/BS college degree or its equivalent Work Experience:

Minimum of 5 years of experience in Clinical Operations or other related drug development function Minimum of 3 years of experience with IXRS systems (through vendor management or as a

provider) Experience supplying Investigational Medicinal Products for global multi-center studies Project Management experience preferred Strong knowledge and understanding of Good Clinical Practices (GCP) Ability to work on and lead cross-functional teams Ability to facilitate meetings, drive discussions and develop processes Demonstrated leadership with excellent interpersonal, communication, and negotiation skills Strong analytical skills; ability to diagnose complex issues and implement processes within Clinical

Operations Organized with good attention to details; ability to review and provide feedback on technical

documents The IXRS Manager will manage all aspects of the Interactive Voice/Web Response Services (IXRS) in support of Onyx clinical trials. Responsibilities will include standardizing workflow processes and standards and ensuring adoption across the organization and with business partners. The IXRS manager will define preferred vendor criteria, select preferred vendors and define metrics to measure vendor performance. 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

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medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Apply on company website

Project Manager/Sr. Manager - San Francisco, CA Medivation - San Francisco, CA Posted 12 days ago

Job description Project Manager / Senior Manager Medivation, Inc. (NASDAQ: MDVN – www.medivation.com), a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Project Manager / Sr. Manager, reporting directly to the Associate Director, Project Management. Incumbent will work closely with the commercial team on Medivation’s first marketed product, XTANDI. Internally, s/he will interface directly with multiple functional areas such as: clinical operations, regulatory affairs, biometrics, medical affairs, commercial and research as required by the projects s/he is assigned to manage. Extensive interaction with our co-promote partner, Astellas, will be required. Essential duties and responsibilities include but are not limited to the following: • Develop project plans that delineate activities that must be completed by commercial • Pull in necessary resources from the functional areas to ensure that these tasks are completed in a timely and high quality manner; lead project teams to maintain focus on task completion and highlight deviations from the project plans and bring solutions to senior management and team members on how to get projects back on track • Ensure timely launch of new indications in close coordination with co-promote partner; put in place the necessary focus on getting internal and alliance partner input that will increase the probability of new product commercial success • Support Joint Commercialization Committee in conjunction with Alliance management to ensure smooth communications and timely completion of agreed upon tasks Requirements: • 6-8 years experience in project management in the life science industry (including pharmaceutical manufacturers, biotechnology manufacturers and medical device manufacturers) • Experience in project managing commercial including direct experience in product launches • Experience in a co-promote is a plus. • Understanding of the pharmaceutical/medical products culture and the special requirements of completing projects within a regulated environment • Must have had experience in managing projects that had a 2 year + timetable for completion and involved tasks from a range of disciplines • Highly Proficient with MS Office (Word, Excel, PowerPoint) Outlook or similar calendar system, familiarity with SharePoint and WebEx (or other similar systems); MS Project

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• Strong Leadership Skills • Excellent interpersonal, organization, verbal and written communication skills • Problem-solving skills • Attention to detail • Ability to organize and prioritize tasks in a timely and accurate manner • Ability to meet tight deadlines • Ability to work collaboratively in a dynamic environment • A solution seeker who is pre-disposed to find opportunities for improvement and can recommend solutions • Travel - 30% Education: • BS/BA degree required Note: Internet Explorer is required to apply to positions. You may email your resume to hrpostings@medivation.com, if you do not have access to Internet Explorer. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V Apply on company website

Manager Regulatory Affairs Adamas Pharmaceuticals, Inc. - San Francisco Bay Area Posted 5 days ago

Job description The Manager, Regulatory Affairs will play a dual role in the regulatory department. Firstly, the Manager will play a lead role in electronic submissions, including serving as primary contact for eCTD vendor. This position will serve as our in-house subject matter expert on e-submissions, training and support of functional areas. In addition, the Manager, Regulatory Affairs is also responsible for general regulatory affairs support, including regulatory research, under the direction of Vice President of Regulatory Affairs. This position will be based at Adamas Emeryville facilities and will report to Vice President, Regulatory Affairs. Responsibilities:

Provide primary support for electronic publishing of regulatory submissions. Manage eCTD lifecycle. Manage training and development of Adamas personnel on eCTD templates and processes Draft routine submissions including annual IND reports and investigator submissions Prepare materials for meetings with FDA Maintain regulatory files Conduct regulatory research.

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Review databases/websites for current regulations and guidance documents relevant to drug development projects.

Desired Skills and Experience Requirements:

BA/BS degree or equivalent experience in related field preferred 5+ years experience in regulatory affairs publishing with hands on experience processing INDs and

NDAs In depth knowledge of content and organization of regulatory submissions in eCTD format Comfortable handling fast-moving priorities while maintaining a consistent, professional demeanor High degree of accuracy, extremely detail oriented Resourceful, can work creatively to resolve complex issues Communicates effectively with other functional areas Advanced skills in using Microsoft Office Word and Adobe programs as well as publishing tools. Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of

documents

http://www.linkedin.com/jobs2/view/9980256?trk=job_view_browse_map

Director, Global Regulatory Affairs Astex Pharmaceuticals - San Francisco Bay Area Posted 5 days ago

Job description Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc., www.astx.com, brings together high tech and biotech to discover and develop more effective medicines for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. This position will be based in the Corporate Office located in Dublin, California, just a 10-minute shuttle ride from the Dublin-Pleasanton BART station. The Director, Global Regulatory Affairs will support oncology development programs, provide regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions, and regulatory processes. Reporting to the Vice President of Regulatory Affairs and Quality, this individual will lead Regulatory Submission Teams, design programs for complete and accurate IND/CTA submissions, and ensure that clinical trials are designed to meet regulatory requirements. Responsibilities: · Plan content and timelines of regulatory submissions to ensure alignment with agreed strategies · Proactively identify regulatory issues and provide solutions to keep our programs on time, while maintaining the highest quality · Lead efforts for coordinating content and publishing documents for original INDs, Clinical Trial Applications and NDAs, and their associated maintenance · Lead multidisciplinary efforts to produce an IND every year · Work with department management on plans for NDA/MAA submissions and lead their preparation · Take the lead role in Astex preparations for Regulatory Agency meetings · Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for Regulatory Authority meetings · Work with offshore regulatory organizations to prepare applications, respond to queries, and maintain our clinical activities outside of the United States · Maintain knowledge of the current regulatory environment, and interpret and communicate relevant issues to your colleagues

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· Assure compliance with regulatory standards and guidance documents · Prepare, submit, track, index, and archive electronic submissions · Provide Regulatory guidance to our Manufacturing, Discovery and Development teams · Liaise with Medical Writing for coordinating and publishing all documents · Although this position collaborates extensively with others, there are no direct reports at this time

Desired Skills and Experience Qualifications: · PhD or PharmD in life sciences with 8+ years of regulatory affairs experience is preferable, or BS/MS in life sciences with 15+ years of regulatory affairs experience · Extensive submissions experience at the IND and NDA stages, and prefer to manage projects · Experience with FDA, other health authority meetings/ interactions desirable · Documented history of successful interactions with regulatory authorities in North America and Europe · Flexibility combined with the ability to prioritize and manage multiple tasks simultaneously is essential · Broad background and ability to work across multiple functions · Experience with oncology drug development is highly desirable · Knowledge of the drug development process, drug laws, and global regulations and requirements required · Effective oral and written communication skills · Strong analytical skills, problem solving ability, communication, and presentation skills required · Proficiency using Microsoft Office products and electronic systems required · Familiarity with project management principles is a plus 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ Meredith McClanahanRecruitment Services Specialist at BioPhase Solutions

http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=3219 Lab Tech III biophaseinc.com BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Lab Tech III to work for a leading Bay Area biotechnology company. We are recruiting for a long term.. *********************************************************************************************************************** Darshana’s Job Opportunities for December, 2013 are posted in JOBS category at www.darshanavnadkarni.wordpress.com. When sending in CV, identify the job in the subject line, identify gaps, include some background about how the job description matches your experience, include resume as an attachment, and email it to wd_darshana at hotmail dot com. Some immediate opportunities include, Bioinformatics Developers, ios/Android developers, Regulatory Affairs Dir/ VP, Dir of Quality Engineering, Dir. of Mechanical Engineering, and Senior Mechanical Engineer.

Apply on company website

Director, International Regulatory Submissions (Clinical) Cepheid - US - San Francisco Bay Area Posted 6 days ago

Job description In this critical role of Director of International Regulatory Submission (Clinical), the successful candidate will be part of the Regulatory Affairs management team and develop submission and clinical trial strategy

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for international countries to support new product development efforts, as well as expansion into new international markets. The objective is to maximize the regulatory approval of Cepheid products throughout the world. The candidate will directly manage a team of regulatory personnel responsible for all Cepheid international submissions.

Oversee the direction, planning, execution, and interpretation of international regulatory submissions.

Directly interface with international regulatory agencies in order to expedite approval of pending registrations.

Responsible for managing the international regulatory team which is responsible for the following countries /regions.

Canada Latin and South America Europe Asia Australia Middle East Responsible for oversight of the China and Japan clinical trials including clinical site selection, study

initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.

Partner with global and regional marketing in the development of regulatory plans. Establish and review Regulatory Affairs priorities as they relate to department and company goals

and objectives. Maintain a "focused urgency" as required by specific events. Suggest significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex

or involve multiple organizational areas. Recognize potential problems, including situations that include ambiguity, by actively reviewing and

analyzing internal and external factors. Formulate short-term planning for individual deliverables and participate in long term planning

within the unit.

Desired Skills and Experience Bachelor’s degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or

Human Physiology or a related discipline A minimum of 8 years experience in a fast paced regulatory team at a medical device/IVD

company A minimum of 5 years overall management experience in the IVD / medical device industry Experience managing a team's performance to budget and schedule Sound basis of International Regulatory knowledge, especially in the Europe and Asia Regions Proven track record in obtaining international clearance/approval of medical device/In Vitro

Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics, either in cancer or infectious disease diagnostics

Experience with International medical device / IVD regulations and submissions Demonstrate in-depth understanding of advanced technical/scientific principles that relate to

multiple, diverse, and/or complex product lines or manufacturing processes Ability to interpret subjective and complex aspects of specific regulations and has thorough

understanding of multiple sets of associated regulations Able to confidently deal with ambiguous issues and provide input towards suitable actions Strong oral and written communication, and presentation skills Requires approximately 30-40% travel ****************************************************************************** PBSS Free Jobs Link Listing-- http://pbss.org/aspx/jobs.aspx http://pbss.org/aspx/jobdetails.aspx?jID=5090

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Job ID: 5090 Employer: Genentech Position: Associate Scientist/Scientist-(Technology), DMPK Description: Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our South San Francisco, California headquarters: Associate Scientist/Scientist-(Technology), DMPK The department of Drug Metabolism and Pharmacokinetics (DMPK) at Genentech is seeking a highly motivated individual to support drug permeability and transport studies enabling the discovery and development of small molecule drugs. The qualified candidate will work closely with our established team to develop assays and systems to investigate expression and functions of drug transporters, and conduct in vitro permeability and transport studies to address ADME questions and support projects. The successful candidate would have the opportunity to interact with multidisciplinary project teams. Who You Are A PhD in Pharmaceutical/Biological Sciences or other relevant field, with 0-2 years’ industry experience is required. Broad knowledge of biology of drug transporters, extensive experience in cell/tissue culture, molecular biology techniques and ability to design and conduct assays as well as analyze/interpret data are essential. Strong understanding of transporter involvement in drug disposition is required. Excellent organization skills, oral and written communication and flexibility are essential. Good understanding of pharmacokinetic concepts is highly desirable. Experience with LC-MS/MS would be beneficial. Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. Genentech is an Equal Opportunity Employer. Apply Here: http://www.Click2apply.net/n82pzxg Requirements: Location: Contact: South San Francisco, California, United States, 94080 Post Date: 12/4/2013 8:38:13 PM ______________________________________________________________________________ http://pbss.org/aspx/jobdetails.aspx?jID=5089 Job ID: 5089 Employer: Genentech Position: Scientist (ADC Catabolite ID), Drug Metabolism and Pharmacokinetics (DMPK) Description: Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our South San Francisco, California headquarters: Scientist (ADC Catabolite ID), Drug Metabolism and Pharmacokinetics (DMPK) The DMPK group is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates and ADC. We accomplish this through the application of state of the art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings. The department of Drug Metabolism and Pharmacokinetics (DMPK) at Genentech is seeking a highly motivated

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candidate with experience in supporting antibody drug conjugate (ADC) projects in discovery and development. The candidate will work on identifying catabolites from various in vitro or in vivo sources. He/she will work to develop and implement various in vitro assays that could be used to better predict in vivo disposition of ADC. The candidate will participate in planning, performing and interpreting results. He/she will work closely with project teams to guide the teams in drug design with respect to improving the next generation of ADC molecules. Who You Are A PhD degree is desirable in pharmaceutical, biological, chemical or any other relevant programs with a strong experimental metabolism background with at least five years of relevant industrial/post-doc experience. Hands-on experience with chromatographic separation by LC and small molecules structural elucidation by MS/MS analysis (knowledge of large molecule bioanalysis – in particular ADCs - is a plus). Experience with in vitro ADME studies and capable of trouble-shooting assays. Candidates must be highly motivated, organized, excellent communication skills (both oral and written), detail oriented, and a good team player. A good understanding of clearance mechanisms of both small and large molecule is a plus. Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. Genentech is an Equal Opportunity Employer. Apply Here: http://www.Click2apply.net/gj6pkxh Requirements: Location: South San Francisco, California, United States, 94080 Contact: Post Date: 12/4/2013 8:31:21 PM *********************************************************************************** ******************************************************************************* Qualified candidates please reply to: Cindy Johnson tel: 925-577-8135 cjohnson@chozeninc.com REGULATORY, QUALITY & CLINICAL AFFAIRS Clinical Trainer • BSN is required • Certification as a NP by the certifying body is required. • Licensed to practice within state of California, as a NP is required. • BCLS required, ACLS preferred. Life savings certification • Demonstrate a strong customer-oriented attitude. Some sales-oriented experience would be preferred. • Excellent interpersonal, oral and written communication skills are required. • Proficiency with MS Office, including Word and Excel is required. • Occasional flexibility in work hours, including weekends, will be required. Sr. Quality Engineer • BS in Engineering or other related field required • 5+ years experience in Quality Engineering in medical device field • Class III device experience is a plus • Proficiency with statistical software package and CAD software is preferred • Strong knowledge of current requirements & methodologies (Process Validation, Risk Management, FMEA’s, Design Control) • Experience with FDA requirements, working knowledge of Japanese MHLW ministerial ordinance 169 Sr. Regulatory Affairs Manager • BS/BA in relevant field, advanced degree is desirable • 8+ years experience in Regulatory Affairs within the medical device industry • Class III device experience is required

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• Experience with MDR’s, IDE’s, PMA’s and 510K filings • Interventional cardiology experience would be a plus • Excellent written and oral communication skills; technical writing capabilities are a must • Previous management experience is required Regulatory Compliance/Quality Systems Associate • Bachelor’s Degree (or equivalent) • 4-5 years of progressive responsibility with at least 3 years in the medical device industry/biotechnology in a Quality System/ Quality Assurance and Regulatory capacity. • Working knowledge of regulatory requirements for FDA, ISO13485, CMD/CAS & other International requirements • CAPA & Complaint Handling experience required • Excellent verbal, writing, and interpersonal communication skills • Basic knowledge of GxPs (cGMP, GDP) • Science background and basic statistical knowledge. • Computer skills _____________________________________________________________________________ SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT International Sales & Marketing Manager • Bachelor’s degree required • 5+ years experience in Sales, Marketing and Project Management in medical device field • Fluency in foreign languages such as Portuguese, Spanish, Russian or Chinese strongly preferred • Prior knowledge of International business development • Excellent written and verbal communication skills • Proficiency in M S Office and Salesforce.com • Ophthalmic knowledge/experience is a strong plus Administrative Assistant – International Sales & Marketing • Bachelors degree strongly preferred • 4+ years related experience in the medical device industry • Proven Project Management skills are desirable. • Prior knowledge of International business development a plus. • Fluency in foreign languages such as Spanish, Portuguese, Russian or Chinese a plus. • Knowledge of International exporting and importing desired. • Excellent written and verbal communication skills, combined with outstanding organizational skills are essential. Strategic planning and tactical deployment. • High Integrity and Character. Attention to detail and accuracy is critical. • Ability to work effectively in a fast-paced environment. • Demonstrated experience and success using e-business solutions, Email Marketing, Mobile/SMS, Video, Display Advertising, Social Medias and CRM a plus. • Proficient knowledge of MS office, Salesforce. ************************************************************************************ http://www.linkedin.com/jobs2/view/9957560?trk=eml-anet_dig-b_premjb-ttl-cn Sr. Contract Mechanical Engineer (Full or Part-time) CIRTEC Medical Systems - San Francisco Bay Area - Local candidates only please Posted 5 days ago Job description Want to create the newest concepts in today’s medical devices? Enjoy working, hands-on, producing never seen before prototypes? Seeking to gain experience working with a wide variety of device technologies? You want to work at CIRTEC Medical Systems! Join the team now! We are looking for Mechanical Engineers to augment our engineering team. By being part of one of the leading contract medical device design companies in the valley, you will be at the center of class III device innovation. In this role you will be a part of product development for the next generation of catheters, pumps, surgical instruments, and active implantable devices. Responsibilities

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Applies engineering knowledge and skills as technical engineer for all phases of project development

Participates in, and sometimes leads, efforts to create specifications and develop designs to meet those specifications

Prepares medical device documentation consistent with appropriate standards Participates hands-on in developing prototypes Generates and executes test protocols to verify functionality Creates and releases medical device manufacturing process instructions, bill of materials, lot

history travelers, and related documentation May communicates directly with clients to understand needs and present results Effectively interfaces with and manages suppliers to fabricate prototype and final design

components Participates in product risk management, to develop and implement risk mitigation strategies Requirements

Minimum BSE/BSME Extensive knowledge of materials and processes used in manufacture of medical devices Experience in creating product specs, test protocols, manufacturing procedures Experience with Solidworks (Required) Excellent communication skills both written and oral Familiarity with medical device design control processes Broad range of medical device experience Catheter development experience a plus Experience in development of Nitinol components a plus Only candidates with previous experience within the Medical Device industry will be considered for this role. Thank you ********************************************************************************************************* Meredith McClanahanRecruitment Services Specialist at BioPhase Solutions

http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=3221 Scientist Engineer biophaseinc.com 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... ******************************************************************************************* Ben Ross b.ross@realstaffing.com Good afternoon and thank you for your brief attention. I am writing you today in regards to two Director of Product Development roles that I am currently recruiting for....I know it may not be exactly relevant to you specifically, but I am trying to get the word out and would greatly appreciate your help! The company in need has two commercial products and is looking for two new Directors to join the small team. We need candidates who will be comfortable working independently and wearing multiple hats while still maintaining consistant communication with the team. From a technical standpoint, we would like to see people with a strong cGMP background, parenteral drug development, regulatory guideline knowledge and some CMC section writing for submissions. This company has oral formulations and combo products so we will need one Director to have experience with drug-device combo development (this is highly preferred). They are offering a competitive package and interviews are starting this week, so I appreciate the urgency! Have a great evening, and thank you again! ********************************************************************************** Interested parties should contact/send resume to Margaret@JGBBioPharma.com

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Sr. Scientist, Formulation Development – Full Time Position (San Francisco Bay Area) PPBI Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc.

To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Developing and optimizing solid oral dosage manufacturing processes for NCEs, and supervising process technology transfers and scale-up through validation at contract manufacturing organizations. • Supervise the development, optimization and CTM manufacture of early and late stage IR solid dosage forms (tablets and capsules) of NCEs, providing technical leadership. • Report writing, document review and sign-off. Writing to include regulatory documents in support of submissions. • Supervise process development, optimization and scale-up and tech transfers between CMOs. Includes critical studies through process registration and validation. • Hands-on development of solid dosage forms. • Maintain a current awareness of and enforce applicable government regulatory, safety, occupational health, and environmental requirements • Characterize prototype formulations, conduct pre-formulation studies and support development of corresponding analytical methods. • Evaluate the potential for enhancing oral bioavailability of lead drug candidates through application of state of the art formulation technologies • Work closely with other Research and Development teams, actively supporting testing of new drug formulations at various stages of development, meeting project timelines and goals • Present formulation development results at meetings and in technical reports and publications • Represent the formulation group in various inter-disciplinary settings • Track record of NDA CMC sections, and corresponding supporting technical documents and development reports • Maintain a current awareness of formulation and delivery technologies. EXPERIENCE AND QUALIFICATIONS: • Significant direct experience in (IR) solid dosage formulation and process development, optimization and scale-up of NCEs, utilizing statistical designs of experiments • A working knowledge of ICH and FDA guidelines • Working knowledge in analytical techniques used for testing, characterization and in-vitro comparison of solid dosage forms • Prior experience designing pre-formulation and stability studies for small molecule oral formulations • Demonstrated ability to efficiently manage contractors and to build and maintain excellent working relationships with outside parties • Excellent written and verbal communication skills • A self-directed team player able to work in an interdisciplinary, fast-paced environment • Prior experience working in a GMP environment • Willing to travel to meet project needs • A Ph.D. in Pharmaceutics, Pharmaceutical Chemistry, Chemical Engineering or a related field • A minimum of 10 years of small molecule oral formulation development experience in the pharmaceutical/biotech industry Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc. _________________________________________________________________

Senior Clinical Research Associate (SCRA) – Full time position (San Francisco Bay area) PPBI Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc.

To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION:

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Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements. Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents Develop study budget and timelines Prepare regulatory documents and submissions Execute project specific training for internal and external staff Maintain Trial Master File Manage Investigational Product (IP) Manage safety reporting Procure and manage contracts with CROs, study vendors and investigative sites Provide oversight of CROs, independent field monitors and other clinical vendors Review monitoring trip reports and track resolution of all action items Co-monitor at investigative sites to evaluate study site and field monitor performance Collaborate with medical experts, clinical study sites, and clinical study vendors Performs in-house review of clinical database listings for completeness and accuracy Develops clinical study reports EXPERIENCE AND QUALIFICATIONS: BS/BA degree in a life science, RN, or related fieldAble to collaborate effectively with the study team, cross-functional team members, and external partners Knowledge of ICH/GCP and FDA regulations Proficiency in MS Word, Excel and Powerpoint 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience) Experience in oncology preferred Experience in global trials preferred Experience with Electronic Data Capture systems preferred Able and willing to travel approximately 25-30% Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc http://www.jgbbiopharma.com/jobs-category/clinical-jobs **************************************************************** Ronald H. Coelyn E-mail: rcoelyn@coelyngroup.com Phone: 817-424-3652 web: http://www.coelyngroup.com Our Firm is currently working on several executive search projects for lifescience industry clients. We would value your help in identifying some exceptional candidates for one very special client in particular. This client is an early stage medical device company developing clinical solutions for the diagnosis and treatment of arrhythmia. The Company currently anticipates commercialization of its products in 2014. As the technology is proprietary and highly confidential nothing more can be said about it at this time. President & Chief Executive Officer He/she will be a highly respected, visionary leader in his/her industry sector, with a demonstrated track record of success in building businesses through hands-on interaction with his/her teams. Product commercialization, strategic marketplace positioning, sales force management, business development, and highly effective profit and loss ("P&L") management (including the generation of positive cash-flow) should have been cornerstones of prior accomplishment.

12/8/2013 15

We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals. ********************************************************************************************************************

To apply for a position send your resume to Jobs@JGBBioPharma.com ______________________________________________________________________________ CRAII/ Senior Clinical Research Associate / Clinical Trial Manager Job description

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.

Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements

Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents Develop study budget and timelines Prepare regulatory documents and submissions Execute project specific training for internal and external staff Maintain Trial Master File Manage Investigational Product (IP) Manage safety reporting Procure and manage contracts with CROs, study vendors and investigative sites Provide oversight of CROs, independent field monitors and other clinical vendors Review monitoring trip reports and track resolution of all action items Co-monitor at investigative sites to evaluate study site and field monitor performance Collaborate with medical experts, clinical study sites, and clinical study vendors Performs in-house review of clinical database listings for completeness and accuracy Develops clinical study reports Desired Skills and Experience Excellent verbal and written communication skills Attention to detail Able to organize, manage and set priorities for multiple tasks Strong leadership skills, self-motivated, adaptable to a dynamic environment Able to collaborate effectively with the study team, cross-functional team members, and external

partners Knowledge of ICH/GCP and FDA regulations Proficiency in MS Word, Excel and PowerPoint Able and willing to travel approximately 25-30% 3+ years relevant clinical experience in a CRO, pharmaceutical, or biotechnology company

(including on-site monitoring experience) for CRAII, 5+ for SCRA, 7+ for CTM Experience in global trials preferred Experience with Electronic Data Capture systems preferred BS/BA degree in a life science, RN, or related field ______________________________________________________________________________ Director, Clinical Outsourcing and Administration – Full Time Position (San Francisco Bay Area) X114GM DESCRIPTION: The Director of Clinical Outsourcing & Administration is responsible for the development, oversight, and execution of processes related to the outsourcing and contracting activities supporting clinical trials, including ongoing development and execution of the Clinical Operations sourcing strategy. This will involve building partnerships with the Clinical department's leadership, Procurement, Legal/Contracts management, FP&A, and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in an optimal and efficient manner that is consistent with company policy, as well as legal, government, and regulatory requirements where relevant. The suitable candidate will need to forecast full study budgets and keep them up-to-date working closely with each study manager or leader. The candidate will need to work closely with finance to assure the assumptions for the studies are aligned between finance and clinical forecasting.

12/8/2013 16

The incumbent will develop and lead the RFP process for associated clinical trial vendors, ensuring that costs, clinical trial budgets, and financial structure is based on fair and reasonable pricing, and will coordinate with Procurement to ensure appropriate financial risk mitigation as appropriate and in accordance with company regulations. This role acts as a central point of consolidation for assessing vendor progress against approved contracts, deliverables, and timelines, interfacing with Finance, Clin Ops, Procurement, and other stakeholders as required to provide real-time assessment of actual work performed. This position manages Clinical Outsourcing & Administration department functions and personnel, in addition to liaising with cross-functional teams, as appropriate. In addition, the candidate will review all incoming invoices of significance against the contract executed with vendors to assure that the forecasts put in place are aligned with actual expenses. Key Accountabilities/Core Job Responsibilities: An understanding of financial forecasting and tracking is a necessity. Ability to review invoices vs forecast is necessary. The candidate will lead and manage the Request For Proposal (RFP) process for outsourced

providers, ensuring a thorough evaluation and selection process in accordance with company policy, while achieving optimal cost savings and fair pricing for all study budgets and costs associated with clinical trials.

Monitor and report status & progress of clinical contracting efforts against timelines and objectives, and effectively communicate progress proactively as needed to stakeholders.

Assist in assessing work performed by outsourced vendors and monitoring compliance with contractual terms, budgets, payment terms, or other objectives. Review all invoices for contractual consistency and reflection of actual work performed.

Build, maintain, and manage vendor relationships to ensure they meet client’s business needs in a timely, quality focused, and cost effective fashion and to provide a single point of contact with providers.

Own and maintain an established preferred clinical vendor list and develop governances with such vendors; maintain historical study budget pricing databases & tracking as appropriate for robust reference capability.

Identify process improvements in the contracting, negotiation and cost-savings practices that support outsourced activities in the organization.

Develop, implement, and manage cost saving initiatives as appropriate and in alignment with business unit goals.

Manage the generation, negotiation and execution of clinical trial budgets and associated spend. Approve clinical patient budget negotiating parameters for CROs. Design and maintain outsourcing SOPs, RFPs templates, Change Order logs, outsourced provider

performance management dashboards, Master Service Agreements (MSA’s) and project-specific agreements.

Partner with clinical study teams on vendor selection, providing performance expectations, ongoing budget/contract review support, and goal/metric development and issue resolution.

Support vendor management and issue escalation by negotiating change orders and ensuring provider adherence to contract terms.

Facilitate interaction between the study team, Finance, Procurement, and Legal to communicate and resolve budget, financial, contractual and performance related issues.

Supervise the management of department personnel. Identify and assess appropriate industry outsourcing benchmarks and metrics. Collaborate with Clinical study teams to deploy good customer service as needed and in a timely

fashion, while utilizing professional outsourcing practices. Collaborate with Clinical study teams in managing various outsourced clinical providers to ensure

delivery within the agreed budget and timeframe. Work closely with Clinical Operations/Project Management, Legal, and FP&A to ensure fiscal

budgets and re-forecasts reflect current status of clinical study activities and budgets EXPERIENCE AND QUALIFICATIONS: 8-10 years of vendor management and contract management experience, preferably with vendors

supporting clinical trials An understanding of study budget forecasting is necessary. Previous experience in working with clinical operations and finance is a plus.

12/8/2013 17

Thorough understanding of Good Clinical Practices and applicable regulatory and legal requirements governing conduct of clinical trials.

Can negotiate skillfully in tough situations with both internal and external groups. Effectively copes with change and is comfortable changing direction and leading through periods of

ambiguity. Ability to operate effectively in a global, matrix environment. Leadership: ability to communicate a compelling and inspired vision or sense of core purpose,

dealing with issues, working through conflicts, and persuasively influencing outcomes. Motivator: invites and stimulates input, shares ownership and visibility, empowers others. Team builder: defines success in terms of whole team, thinks and acts globally 4-year college degree with BA/BS in Life Sciences, Finance, Business Strategy, or related field ______________________________________________________________________________ Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R DESCRIPTION: This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices. Key Accountabilities/Core Job Responsibilities: Develops and oversees CTMF document control policies, procedures, processes and systems in

accordance with all applicable regulatory requirements and established procedures and policies. Develops document management systems to meet the needs of the Clinical Development

department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).

Develops, implements and maintains CTMFs for all clinical trials. Interacts with Clinical Development department staff and relevant cross-functional departments to

establish priorities and deadlines for processing and filing of CTMF required documents. Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance

with regulatory requirements and procedures and processes. Manages and controls the paper-based CTMF storage room and its contents. Manages and controls the eCTMF storage and maintenance systems. Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and

maintained in accordance with all applicable regulatory requirements and procedures and processes. Develops and manages the archiving systems and retrieval of archived CTMF documents. Functions as the Subject Matter Expert for CTMF document management systems and processes

within Provides CTMF support and guidance for internal and external CTMF audits. Provides CTMF support and guidance for US and Ex-US regulatory authority inspections. EXPERIENCE AND QUALIFICATIONS: Excellent working knowledge of current paper-based CTMF systems and standards and GCPs. Excellent working knowledge of current electronic CTMF systems and standards. Ability to analyze and reconcile complex issues independently. Ability to independently and effectively manage assigned task and projects. Ability to lead and manage CTMF support personnel. Ability to develop or update Standard Operating Procedures and Work Instructions. Excellent verbal and written communication and interpersonal skills. Must be an individual with proven initiative and demonstrated ability in a fast paced environment Established experience and knowledge of general CTMF systems and standards. Established experience and knowledge of paper-based document CTMF systems. Established experience and knowledge of electronic CTMF systems. Established experience providing CTMF support for US and Ex-US regulatory authority inspections Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements. Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite. Established experience with design, development and implementation of a paper-based CTMF

storage room. Established experience with identification, selection, implementation and maintenance of an

electronic CTMF system.

12/8/2013 18

Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.

Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

____________________________________________________________________ To apply for a position send your resume to Jobs@JGBBioPharma.com Coordinator – Contract (Arizona) 4598 DESCRIPTION: Provide administrative support to multiple Directors and/or Vice President in a high volume

environment. Responsible for drafting sales support materials, maintaining filing and record keeping systems,

coordinating data collection, and generating reports. Facilitate travel/meeting plans, and prepare and track reports and budgets EXPERIENCE AND QUALIFICATIONS: Candidates should be self-directed and proactive, possess solid project management,

communication, planning and organizational skills. Comfortable and effective working independently with little supervision within a deadline-driven

environment, providing constant attention to detail and follow-up. A minimum of five years related experience is required, preferably in the pharmaceutical industry. Proficient in Word, PowerPoint and Outlook. High School Diploma; some college courses preferred. Director, Clinical Outsourcing and Administration – Full Time Position (San Francisco Bay Area) X114GM DESCRIPTION: The Director of Clinical Outsourcing & Administration is responsible for the development, oversight, and execution of processes related to the outsourcing and contracting activities supporting clinical trials, including ongoing development and execution of the Clinical Operations sourcing strategy. This will involve building partnerships with the Clinical department's leadership, Procurement, Legal/Contracts management, FP&A, and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in an optimal and efficient manner that is consistent with company policy, as well as legal, government, and regulatory requirements where relevant. The suitable candidate will need to forecast full study budgets and keep them up-to-date working closely with each study manager or leader. The candidate will need to work closely with finance to assure the assumptions for the studies are aligned between finance and clinical forecasting. The incumbent will develop and lead the RFP process for associated clinical trial vendors, ensuring that costs, clinical trial budgets, and financial structure is based on fair and reasonable pricing, and will coordinate with Procurement to ensure appropriate financial risk mitigation as appropriate and in accordance with company regulations. This role acts as a central point of consolidation for assessing vendor progress against approved contracts, deliverables, and timelines, interfacing with Finance, Clin Ops, Procurement, and other stakeholders as required to provide real-time assessment of actual work performed. This position manages Clinical Outsourcing & Administration department functions and personnel, in addition to liaising with cross-functional teams, as appropriate. In addition, the candidate will review all incoming invoices of significance against the contract executed with vendors to assure that the forecasts put in place are aligned with actual expenses. Key Accountabilities/Core Job Responsibilities: An understanding of financial forecasting and tracking is a necessity. Ability to review invoices vs forecast is necessary. The candidate will lead and manage the Request For Proposal (RFP) process for outsourced

providers, ensuring a thorough evaluation and selection process in accordance with company policy, while achieving optimal cost savings and fair pricing for all study budgets and costs associated with clinical trials.

Monitor and report status & progress of clinical contracting efforts against timelines and objectives, and effectively communicate progress proactively as needed to stakeholders.

12/8/2013 19

Assist in assessing work performed by outsourced vendors and monitoring compliance with contractual terms, budgets, payment terms, or other objectives. Review all invoices for contractual consistency and reflection of actual work performed.

Build, maintain, and manage vendor relationships to ensure they meet client’s business needs in a timely, quality focused, and cost effective fashion and to provide a single point of contact with providers.

Own and maintain an established preferred clinical vendor list and develop governances with such vendors; maintain historical study budget pricing databases & tracking as appropriate for robust reference capability.

Identify process improvements in the contracting, negotiation and cost-savings practices that support outsourced activities in the organization.

Develop, implement, and manage cost saving initiatives as appropriate and in alignment with business unit goals.

Manage the generation, negotiation and execution of clinical trial budgets and associated spend. Approve clinical patient budget negotiating parameters for CROs. Design and maintain outsourcing SOPs, RFPs templates, Change Order logs, outsourced provider

performance management dashboards, Master Service Agreements (MSA’s) and project-specific agreements.

Partner with clinical study teams on vendor selection, providing performance expectations, ongoing budget/contract review support, and goal/metric development and issue resolution.

Support vendor management and issue escalation by negotiating change orders and ensuring provider adherence to contract terms.

Facilitate interaction between the study team, Finance, Procurement, and Legal to communicate and resolve budget, financial, contractual and performance related issues.

Supervise the management of department personnel. Identify and assess appropriate industry outsourcing benchmarks and metrics. Collaborate with Clinical study teams to deploy good customer service as needed and in a timely

fashion, while utilizing professional outsourcing practices. Collaborate with Clinical study teams in managing various outsourced clinical providers to ensure

delivery within the agreed budget and timeframe. Work closely with Clinical Operations/Project Management, Legal, and FP&A to ensure fiscal

budgets and re-forecasts reflect current status of clinical study activities and budgets EXPERIENCE AND QUALIFICATIONS: 8-10 years of vendor management and contract management experience, preferably with vendors

supporting clinical trials An understanding of study budget forecasting is necessary. Previous experience in working with clinical operations and finance is a plus. Thorough understanding of Good Clinical Practices and applicable regulatory and legal requirements

governing conduct of clinical trials. Can negotiate skillfully in tough situations with both internal and external groups. Effectively copes with change and is comfortable changing direction and leading through periods of

ambiguity. Ability to operate effectively in a global, matrix environment. Leadership: ability to communicate a compelling and inspired vision or sense of core purpose,

dealing with issues, working through conflicts, and persuasively influencing outcomes. Motivator: invites and stimulates input, shares ownership and visibility, empowers others. Team builder: defines success in terms of whole team, thinks and acts globally 4-year college degree with BA/BS in Life Sciences, Finance, Business Strategy, or related field Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R DESCRIPTION: This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices. Key Accountabilities/Core Job Responsibilities:

12/8/2013 20

Develops and oversees CTMF document control policies, procedures, processes and systems in

accordance with all applicable regulatory requirements and established procedures and policies. Develops document management systems to meet the needs of the Clinical Development

department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).

Develops, implements and maintains CTMFs for all clinical trials. Interacts with Clinical Development department staff and relevant cross-functional departments to

establish priorities and deadlines for processing and filing of CTMF required documents. Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance

with regulatory requirements and procedures and processes. Manages and controls the paper-based CTMF storage room and its contents. Manages and controls the eCTMF storage and maintenance systems. Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and

maintained in accordance with all applicable regulatory requirements and procedures and processes. Develops and manages the archiving systems and retrieval of archived CTMF documents. Functions as the Subject Matter Expert for CTMF document management systems and processes

within Provides CTMF support and guidance for internal and external CTMF audits. Provides CTMF support and guidance for US and Ex-US regulatory authority inspections. EXPERIENCE AND QUALIFICATIONS: Excellent working knowledge of current paper-based CTMF systems and standards and GCPs. Excellent working knowledge of current electronic CTMF systems and standards. Ability to analyze and reconcile complex issues independently. Ability to independently and effectively manage assigned task and projects. Ability to lead and manage CTMF support personnel. Ability to develop or update Standard Operating Procedures and Work Instructions. Excellent verbal and written communication and interpersonal skills. Must be an individual with proven initiative and demonstrated ability in a fast paced environment Established experience and knowledge of general CTMF systems and standards. Established experience and knowledge of paper-based document CTMF systems. Established experience and knowledge of electronic CTMF systems. Established experience providing CTMF support for US and Ex-US regulatory authority inspections Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements. Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite. Established experience with design, development and implementation of a paper-based CTMF

storage room. Established experience with identification, selection, implementation and maintenance of an

electronic CTMF system. Established understanding and experience with Web-based applications for controlled document

indexing, tracking and viewing. Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical

or biotech CTMF development and management experience, or equivalent experience. Sales Analyst – Contract (Southern California) 5509A73 DESCRIPTION: Collaborate with District Managers/Account Managers in identifying specific selling opportunities at

specific accounts/territories. Provide standard revenue and performance reporting/analysis, business reviews, build

reports/sales tools, maintain systems infrastructure, and ad hoc analytics. Work closely with the Regional Vice Presidents to assist in driving regional initiatives and objectives Participate in weekly/monthly calls with District Managers to review selling opportunities, account

strategies and other activities. Assist sales team in developing customer specific sales strategies and tactics as part of the

Business Plan process. Drive sales force effectiveness initiatives to the sales force.

12/8/2013 21

Partner with regional marketing and business unit leaders to identify and drive revenue gaining opportunities.

Drive training and use of selling tools available to the field teams to better manage/grow their business.

Assist with maintaining Cognos revenue reporting, and provide guidance and training to sales team as needed.

Assist with driving behavioral changes with the sales force to maximize selling results and overall productivity.

Help drive internal improvements and efficiencies within the Sales Operations team. EXPERIENCE AND QUALIFICATIONS: Strong communication and organizational skills with the ability to interact effectively with

management and sales reps on the phone and establish good rapport Ability to organize and analyze large sets of data into meaningful and concise reports, and propose

solutions to management and sales force Ability to work independently, multi-task and respond to requests in timely manner Strong Excel and PowerPoint skills Proficiency with MS Access a plus Cognos and Siebel experience a plus Four year bachelor’s degree, preferably in Finance, Business Administration, Marketing, or

Communications 3-5 year sales analysis experience a plus Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP DESCRIPTION: Lead the statistical programming activities for multiple compounds and will lead the programming

submission related activities. Establish standards for programming and efficiency within the group. Manages a team of statistical programmers. Identifies new tools to increase group productivity. Ensures programming and corresponding documentation is completed in a manner that is

consistent with departmental procedures. Provides primary and secondary programming support as needed and harmonizes strategic

initiatives (e.g., process improvement) across a therapeutic area or equivalent. Excellent verbal and written communication skills and interpersonal skills are required.Has

understanding of the business beyond the functional area. Capable of recommending new operating procedures as appropriate and determining if the analysis

infrastructure needs changes to improve efficiency and minimize errors. Must be able to lead strategic initiatives for the statistical programming group. Represents the statistical programming group at project team meetings. Has the proven ability to directly supervise personnel. EXPERIENCE AND QUALIFICATIONS: Submission, ISS, and ISE expertise Leadership skills Experience in multiple therapeutic areas is desired Experience in clinical development statistical programming methods and processes in industry

setting required Experience in direct management of statistical programmers Experience and in-depth knowledge in CDISC including SDTM, ADaM, Metadata, and controlled

terminologies Enable to establish process and develop utilities efficiently for different versions of Implementation

Guides and Standards. Enable to assess the impact of procedural or system changes , and develop/implement strategies to maintain consistency of programming

Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application

12/8/2013 22

Good presentation, oral and written communication skills, including a customer base focus, a commitment to quality management, and problem solving experience.

11 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 7 years of experience and a MS degree in Biostatistics/Computer Science or equivalent, or 5 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ DESCRIPTION: Work closely with marketing to develop product requirements. Work closely with other senior technical staff to identify the key technical challenges to meeting

said requirements, and develop system architectures for IVD products. Improve on the process for system and sub-system verification, including test automation and

traceability to requirements, specifications and risk. Partake in verification and validation testing as needed. These responsibilities also apply to integration testing.

Perform system level modeling to determine power consumption, throughput/speed, cost, etc., for complex IVD products.

Perform risk analysis, compliant to relevant international standards, for products in development. Some lab work with blood based in vitro diagnostics. Support activities and processes in compliance with applicable international standards and FDA

guidelines. EXPERIENCE AND QUALIFICATIONS: Travel requirements: up to 10%. Experience with Regulatory requirements for IVD products Experience with SysML and/or UML, Fluidic and electromechanical systems Experience with MATLAB/Simulink Experience with Code development in one or more of the following: C#, C, Python Experience with DOE, Statistics, and associated tools Good written and oral communication skills are a must. At least eight years overall engineering experience, with at least five years in the medical device or

diagnostics industry, or other highly regulated industry (e.g., aerospace, automotive), including one or more successful product launch.

Direct experience in test automation, and generally improving the process of verification. Direct experience solving complex system engineering issues, including the interaction of the

instrument, assay and consumables, and user. Direct experience working with marketing in the product definition stage, and continuing to the

successful verification and validation of a product. BS in Electrical, Mechanical, or Biomedical Engineering. M.S. or Ph.D. is preferred. Recruiter – Contract (Pennsylvania) 6507 DESCRIPTION: Will focus on manufacturing and research and development related positions. Responsible for partnering with the organizations they support along with the HRBP's. Ownership/accountability for all openings in client family. Educate client groups on recruiting/staffing processes. Document/track recruiting activities in system. Coach managers on the selection process. Source, screen and interview candidates EXPERIENCE AND QUALIFICATIONS: Must be self-motivated, present well and be able to develop relationships with both managers and

candidates. Ability to navigate through change and demonstrate flexibility as organizational needs shift. 2-3 years of solid recruiting experience. Must develop and implement creative sourcing strategies to identify talent. Bachelor degree preferred with minimum of 5 years relevant experience. Associate Scientist II - R&D – Contract (Maryland) 73J4720

12/8/2013 23

DESCRIPTION: Provide support to a team of scientists engaged in the development of physiologically relevant cell

culture systems, including induced pluripotent stem cells, precursor and somatic cells. Identification of conditions which promote efficient differentiation and in functional characterization

of diverse cell types. Specific duties will include culture of stem cells and other cells types, close interaction with R&D

staff to coordinate and execute experimental analysis and data review. Suggest options for additional experiments. Troubleshoots experiments. Identify and solve elementary problems in experimental designs. Contribute ideas and suggestions to improve protocols, processes and equipment. Lead the documentation of repeatable lab procedures as required. Read literature directly

associated with assigned project. Maintain some familiarity with competitive products and assist with competitive audits or

documentation as required. Comply with all company safety regulations and procedures. Successful candidate will have the ability to effectively handle multiple tasks and learn quickly. Effective communication skills and the ability to work in team environment are essential. Because stem cell cultures require daily feeding and observation, limited weekend work may be

required in order to maintain these cultures and provide support to various senior R&D staff members involved in these projects.

EXPERIENCE AND QUALIFICATIONS: Sterile tissue culture technique required, formal training or demonstrable experience in stem cell

culture is preferred Able to work in dynamic, fast paced team environment Effective communication/interpersonal skills Use of standard cell and molecular biology techniques Fluorescent and phase contrast microscopy Experience with Flow Cytometry and FACS desirable Experience with laboratory automation desirable Experience with qPCR desirable Experience with image analysis desirable Able to assist in design, execution, and analysis of experiments with moderate to low level of

supervision. Highly organized, ability to maintain well documented laboratory protocols and notebooks. Perform other related duties as required and/or assigned. Requires a Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline with

2-3 years experience or the equivalent knowledge and experience attained through completion of Masters Degree.

Industry experience a plus but not required. *************************************************************************

Jobs That Crossed My Desk Through Dec. 2, 2013 ************************************************************************* Apply on company website Director of Product Marketing Omnicell - San Francisco Bay Area Posted 13 days ago Job description Be the Solution. Imagine the Impact. The Director of Product Marketing is an integral part of the marketing management team. S/he is primarily responsible for developing and driving the Company’s product marketing strategy including sales support, product placement, lifecycle management, promotions, pricing and high-level product design requirements, and promotions. The Director of Product Marketing will also provide input into the Product

12/8/2013 24

Strategy and Product Development organization to identify potential areas around existing technology for commercialization that leverage the company’s existing offerings.

Manage the overall product strategy as it relates to the four P’s of marketing including segmentation analysis and customer targeting such that products are identified and positioned to maximize their revenue; Pricing strategy including bundling, value based pricing, coordinated enterprise pricing and mentoring Product Managers in their overall price setting; promotional strategy including an integrated approach to promotion setting.

Product development and asset management including managing the product roadmap to incorporate all elements of the product lifecycle.

Manage the overall Product Management process at Omnicell including a team of dedicated product managers.

Working together with counterparts in the Marketing Communications organization, determine and manage all aspects of the product promotion strategy.

Gather and analyze feedback from customers, sales, marketing, development to orient solutions for widespread deployment in our markets including understanding and representing the customer’s needs, market trends and competitive activity among these segments working with market intelligence

Own the comprehensive marketing plan that ensures the company’s products and technology are strongly positioned in the marketplace while leading the individual product managers in making annual product marketing plans for each of our core solutions

Sharing responsibility for product bookings with our sales counterparts, direct the product marketing team to appropriately manage all aspects of their assigned products – from well-thought-out sales forecasting to product lifecycle management, and top line product growth metrics.

Work closely with peers in marketing management to ensure that there is clear understanding of product requirements and data which will be supported by the Core Team Lead|Product Development group during product development and immediately post-launch

Develop benchmarks and milestones to measure marketing efforts and performance working with Market Intelligence;

Initiate projects and work closely with commercial, government and pre-hospital sales leadership to develop and improve channel and distribution effectiveness, including strategic partnerships.

Spokesperson on behalf of the Omnicell Acute Care Product Line Contribute significantly on multiple levels and across teams as the a key “go-to person” and

strategic leader within the company Desired Skills and Experience

Healthcare Experience a must, Healthcare IT and/or experience with automated dispensing systems a plus.

Experience as a Director of Product Management within the Product leadership team for a software/hardware company (B2B or B2C)

Proven success in complex, solution-oriented market development Experience with agile development processes and monthly or weekly product release cycles "Roll-up-your-sleeves" entrepreneurial, attitude Natural ability to relate to customers and prospects Superb collaborator Proven ability to manage direct and cross functional teams in a positive and collaborative

leadership style Bachelor's degree (MBA or other Master's preferred) Working Conditions: This position is based in Mountain View, CA with 35% field travel Omnicell, Inc. (NASDAQ: OMCL) is a leading provider of automation and business information solutions enabling hospitals and other healthcare organizations to streamline the medication administration process and manage costly medical supplies for increased operational efficiency and enhanced patient safety. Since 1992, more than 2,600 hospital customers worldwide have utilized Omnicell’s medication automation, supply chain, and analytics solutions. Our dedicated employees and unique culture focused on customer intimacy have garnered us respect and recognition in our industry. Every day, around the world, our people play a vital role in improving healthcare for everyone. Let Omnicell be your solution to a great career and imagine the impact. ******************************************************************************

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Apply on company website Senior Director, Translational Development, Hematology / Oncology Celgene - San Francisco, CA Posted 7 days ago Job description Troubleshooting Tips Job Title: Job ID: 14690 Location: San Francisco, CA Offsite Territory: Full/Part Time: Full-Time Regular/Temporary: Regular Category: Research Department: Translational Medicine - 3268 Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family. In order to apply for open position, you must be currently performing at an Achieves Expectations (AE) level or better, have been in your current position for a minimum of one year* and meet the requirements of the position for which you are applying, except in certain cases of employees applying for positions within their own department. Employees may apply for one position at a time. Relocation assistance is typically not provided on an employee-initiated job posting. Trans-continental moves will only be initiated through Celgene's Talent Planning process. - You must notify your supervisor before applying for this position. Prerequisites: - Advanced degree(s) in relevant field (Hematology, Oncology): MD or MD/PhD. - Extensive academic/industry experience including 8 or more years relevant experience in clinical/translational research with a minimum of 6 years of industry experience and 4 years working on Translational Development activities (e.g., IND submittals, Proof-of-Concept studies, first-in-patient studies, adaptive design studies, biomarker development, companion diagnostics, mechanism of action studies). - Close interaction with or oversight of translational development scientists on discovery research and translational development projects in oncology. Summary: - Part of the TD Leadership team responsible for defining and positioning the early oncology portfolio in collaboration with VP, Translational Development and colleagues in research, clinical development, and marketing - Senior member of the Translation and early Development Team in Oncology. - Medical lead for clinical trials in hematology and oncology from Candidate Nomination (pre-IND) through Proof-of-Concept including: - Articulating the clinical development strategy - Design, implementation and analysis of early stage clinical trials - Clinical leadership on cross-functional Early Development project teams - Close liaison with Translational Development Scientists, Discovery and Development Teams for defining

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Clinical PD or Biomarker assays. - Responsible for clinical drug safety monitoring and management, in conjunction with the drug safety physician - Ad-Hoc Member of the Candidate Development Committee, that evaluates all IND candidates and Early Development programs - Key resource for disease area expertise for the TD team. - Liaise with clinical and laboratory-based academic investigators in Early Oncology and be a focal point for defining and establishing relationships with key Global Phase 1 Centers. - Part of the team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies for cost effective implementation of Celgene’s R & D and early development strategy - Participate in formulating disease area strategy for target selection and validation - Provide support to BD and the established teams, for potential in-licensing opportunities that may include potential therapeutics, emerging technologies, processes or capabilities that will enhance our Drug Discovery and Early Development efforts. Skills/Knowledge Required: - M.D. PhD, 8 years relevant experience with a minimum of 6 years industry experience and 4 years experience in Early/Translational Development. Subspecialty board certification in hematology/oncology preferred. - Proven record of building, leading and integrating cross-functional groups - Track record in leading innovative efforts to deploy technologies and assays for enhanced translational capabilities - Superior leadership, management and organizational skills, and a reputation as an open, available and transparent communicator - Management experience (through direct reports or matrix organization) coupled with strong interpersonal, oral and written communication skills. Strong leadership in representing Translational Developments positions to Senior Management and Executive Committees and International Forums. - Ability to interact effectively across boundaries using influencing and relationship building skills. - Ability to function at the interface of both the Discovery and Development teams, with the aim of providing the successful implementation of stratification strategies, clinical biomarker and pharmacodynamic assays in the early clinical studies - Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals. - Domestic and international travel is expected as required Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene. ******************************************************************************* Apply on company website Clinical Development Medical Writer (Contract to Hire) - San Francisco, CA Medivation - San Francisco, CA Posted 14 days ago

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Job description Clinical Development Medical Writer Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Development Medical Writer. Incumbent will participate in the development of a variety of key clinical and regulatory documents across therapeutic areas and throughout the product lifecycle. Position reports to the Senior Director, Medical Writing. Essential duties and responsibilities include but are not limited to the following: • Plan, organize, and manage tasks related to the development of clinical and regulatory documents such as phase 1 4 protocols, clinical study reports, investigator brochures, informed consent forms, patient narratives, statistical analysis plans, independent committee charters, briefing packages; INDs and updates; NDAs, and regulatory responses • Collaborate with multidisciplinary team members to develop and manage project timelines; ensure that timelines are met, and complete documents according to Medivation standards and processes • Ensure consistency of documents within and across clinical programs by managing content and developing and maintaining document standards, styles, and templates • Participate in SOP development and review Requirements: • Knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards • Advanced skills in researching, writing, editing, reviewing, and managing clinical and regulatory documents • Ability to organize, integrate, summarize, and present scientific and clinical data and information from a variety of primary sources in an accurate, clear, concise, and consistent manner for a variety of audiences • Ability to manage multiple projects in a fast paced environment • Strong record of collaborative multidisciplinary teamwork and innovative problem solving • Knowledge of AMA style, medical terminology, and clinical data analysis • Proficiency in organization and project management • Advanced knowledge and skills using Microsoft Word to generate complex documents • Outstanding attention to detail, goal oriented with assigned tasks, self motivated, professional and friendly demeanor, flexible, accommodating Preferred Qualifications: • Minimum 2 years experience as a clinical/regulatory medical writer in a biotechnology or pharmaceutical company preferred, but willing to train an exceptional, highly motivated and qualified individual

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• Oncology experience preferred • AMWA member with certificate preferred; BELS certification a plus Education: • Bachelor’s degree in a science discipline (advanced degree preferred) or degree in medicine such as RN, PharmD, or MD Position level and responsibilities will be commensurate with education and experience. Note: Internet Explorer is required to apply to positions. You may email your resume to hrpostings@medivation.com, if you do not have access to Internet Explorer. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V Medivation, Inc. (Nasdaq: MDVN) is a biopharmaceutical company focused on the rapid development of novel therapies to treat serious diseases for which there are limited treatment options for patients in need. Medivation blends a unique business model with an expert team to bring promising medical technologies to patients. Medivation is made up of a vibrant, energized group of employees that are proud to be working for an innovative biopharmaceutical company. Medivation’s shared culture is evident through the trust and passion that employees exhibit. Medivation has created a unique community where employees are committed to making a difference in the lives of patients. Medivation launched its first approved product in September 2012. Medivation is a rapidly growing company with 300+ employees, located in beautiful San Francisco. ******************************************************************************* Apply on company website Director, Commercial Planning and Operations – Oncology Gilead Sciences - San Francisco Bay Area Posted 11 days ago Job description The Director CP&O will be responsible for global commercialization activities supporting oncology (85%) and inflammation (15%) molecules. Current pipeline molecules include:

Idelalisib a PI3K-d inhibitor (GS-1101) currently in phase III for indolent non-Hodgkins lymphoma and chronic lymphocytic leukemia

Momelotinib a JAK inhibitor (GS-0387) in phase III for myelofibrosis GS-9973 a SYK inhibitor in phase II for B-cell malignancies Simtuzumab (GS-6624) an antibody targeting LOXL2 in phase II for myelofibrosis, pancreatic and

colorectal cancers GS-5745 an antibody targeting MMP9 in phase I for pancreatic, non-small cell lung and gastric

cancers This position will report directly to the Therapeutic Area lead for oncology and hematology. Three major responsibilities include, but are not limited to:

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1) Support global commercialization efforts for at least one Phase 3 oncology molecule. High-level activities include development of molecule-specific global commercial plan, leading global launch planning including all aspects of branding and campaign development. 2) New Product Planning for the Gilead MPN, solid tumor and inflammation portfolio. This activity requires ability to integrate and influence at a project team level with individuals that represent key functional areas across the organization. This individual will need to demonstrate a strong ability to mobilize a global organization and operate effectively in a matrix team environment. 3) The role is also accountable for commercial assessments to inform decisions at IND, P1, P2 and P3 development milestones as well as providing strategic input and commercial assessments for corporate development activities in oncology and inflammation therapeutic areas. The Director CP&O will be expected to gather input from and provide strategic information to business partners and key stakeholders across the global organization to aid in the overall commercial planning and tactical execution. The Assoc. Director will work closely in collaboration with multiple functional leaders, Project Team Leaders, Regional Business Leaders, US Commercial, Pricing Strategy Leads, Medical Affair Leads, Market Planning, Competitive Intelligence and Clinical Teams to ensure molecule strategies and commercial assessments reflect US and affiliate strategic objectives. In addition this role will be responsible for executing appropriate activities in collaboration with functional partners to ensure that goals are achieved. Incumbents in the Director role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the business conduct of Gilead. Incumbents in the Director CP&O role are generally expected to:

Demonstrate significant leadership skills, business knowledge, analytic and strategic agility, high-level of collaboration, ability to mobilize an organization toward a common goal, and effective communication and presentation skills.

Responsible for providing strategic and tactical inputs into Gilead oncology business planning and review processes, e.g., Commercial Strategic Plans, Tactical 1 Year Brand Plans, Global Launch Plan and Affiliate Specific Plans.

Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

Work collaboratively, effectively and efficiently with all internal and external partners and stakeholders. Includes acting effectively, where applicable, as Gilead co-developed with external partners.

Support his/her manager in a variety of departmental leadership projects and endeavors, e.g., training and development programs for departmental staff, new templates or other tools for departmental work, taking a leadership role in special projects, etc.

Supports and, if needed, represents the respective project teams for business related issues at meetings with Sr. management across the global organization.

Serves as key communication and knowledge transfer link between all key stakeholders within the organization.

Director, CP&O Oncology/Inflammation is based in Foster City. Travel is required. Desired Skills and Experience Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. QUALIFICATIONS & EXPERIENCE:

Bachelors Degree (Marketing, Business Management, or Science discipline is a plus) MBA or other related graduate-level degree is preferred (Master’s or Doctoral degree in a life

sciences field is a plus)

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4-6 years or more previous experience in marketing, market research, competitive intelligence, business development, field sales, or managed care in the pharmaceutical/biotech/or other related industry, with at least 3 years’ previous experience in marketing

1-3 years new product planning preferably global in scope Launch experience is highly preferred Previous experience in leading the development and implementation of brand/product strategy and

vision required Demonstrated ability to lead development and execution of complex plans across multiple priorities Must demonstrate some past experience with, and knowledge of, the drug development process

(pre-clinical and Phase I – III); has worked on core team/project team related projects Must demonstrate strong knowledge of product development, regulatory and clinical affairs Must demonstrate previous experience in, and strong abilities for, establishing relationships with

key opinion leaders and other relevant, external influencers Must demonstrate strong knowledge of message development and clinical publications’ planning Proven track record for consistently meeting or exceeding financial and/or other quantitative

targets, as well as qualitative goals Previous experience in completing & implementing business plans Must demonstrate strong skills in building team and collaboration Business travel, by air or car, is required for regular internal and external business meetings ABILITIES:

Impeccable ethics and integrity Ability, comfort & commitment in/to operating in a highly regulated environment and industry,

which requires understanding of the imperative for compliance with company policies, procedures and other relevant internal or external laws and regulations

Demonstrable abilities to manage more complex marketing responsibilities, to include integration across multiple projects and activities

Has sufficient strategic agility capable of assessing marketplace, product-specific and financial data and translating this into meaningful, appropriate and executable marketing opportunities & plans

Financial acumen; able to create & perform more detailed and sophisticated financial modeling to support or refute recommendations & plans

Demonstrable abilities to oversee the work of other team members and ensure the highest standards, efficiencies and overall effectiveness

Can motivate & inspire others Demonstrable track record of creating innovative/breakthrough marketing strategies for products

in the pharmaceutical/biotech/or other related industries Exceptional organizational skills Outstanding communication, presentation & facilitation skills, able to tailor presentations to

different audiences across the organization Strong influencing & negotiation skills; proven abilities to influence others without authority Strong customer orientation/focus Gilead Sciences was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies. ********************************************************************************** Apply on company website Sr. Product Manager Life Technologies - San Francisco-California-USA

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Posted 14 days agoGet more insights on who's applied with a premium account Job description The capillary electrophoresis business at Life Technologies is a highly successful business that provides the life science market with the gold standard DNA sequencing solution. The business has a global reach across the spectrum of applied, research and clinical market segments. With the launch of the 3500/3500xl instrument series, expanding use of capillary electrophoresis for next gen sequencing confirmation and the adoption of DNA sequencing in the clinical market the platform is entering a new phase of development. Polymer is a critical consumable used by our customers in conjunction with our instruments to sequence DNA. RESPONSIBILITES: The Sr. Product Manager will be responsible for managing and drive DNA sequencing polymer business. The role is responsible for establishing long term strategy, meeting plan revenue and profitability targets, price setting/margin strategies, new product strategy, creating and executing innovative marketing strategies, providing up-to-date product content/information and driving day to day operational effectiveness.REQUIREMENTS / EDUCATION: ·Requires a minimum five (5) or more years experience in product management in Biotech or Life Sciences industries. ·Demonstrated the ability to build and execute a strategic product roadmap development strategy. ·Demonstrated success in product development and introductions, product life cycle management, positioning, pricing, and profitable growth. ·Leadership communication skills to accomplish goal through communication and direction of others. ·A global perspective to develop products that meet global and region-specific needs. ·Demonstrated the ability to be self-motivated & a driving force of product development in their current or past organizations. ·Strong communication and presentation skills Bachelor’s or MBA in Science Minimum Qualifications (must have) Bachelor of Science MBA Preferred Qualifications (nice to have) Master of Science Desired Skills and Experience

Leadership communication skills to accomplish goal through communication and direction of others. A global perspective to develop products that meet global and region-specific needs. Demonstrated the ability to be self-motivated & a driving force of product development in their

current or past organizations. Strong communication and presentation skills Bachelor’s or MBA in Science Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company that is committed to providing the most innovative products and services to leading customers in the fields of scientific research, genetic analysis and applied sciences. With a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions are secured by more than 5,000 patents and licenses that span the entire biological spectrum -- scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012.

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*************************************************************************** http://www.linkedin.com/jobs2/view/9837356?trk=rj_em Pharmaceutical Associate Director of Marketing - SF Bay area The Alpine Group - San Francisco, CA Posted 11 days ago Job description Like to Build Things? A mid-size, high growth pharmaceutical company in the SF Bay area is expanding its commercial operations and needs an Associate Director of Marketing to build and lead a small brand team in the oncology space. This highly profitable drug company has enjoyed annual revenue growth of more than 15% for each of the past three years, and currently has 11 different specialty pharmaceuticals in various stages of clinical development. With a unique, molecular based drug discovery program, they specialize in developing breakthrough treatments for critical, unmet medical needs in the cardiovascular, oncology and pulmonary markets. Their stock price has increased 40% in the past year and they are poised for a period of remarkable growth. If you’re looking for an opportunity to help build something that will last – to apply your marketing skills to a business model with a huge upside potential – then we would like to hear from you. Responsibilities: The Associate Director will plan and execute the launch of a first-in-class product in the oncology market in the U.S. Working initially with one direct report, you will build the segmentation strategy, set the positioning plan, develop the product budget and work with agencies to create the branding and messaging plans. Your team will be responsible for ensuring a successful product launch and implanting a lifecycle management plan for the brand. You will work closely with counterparts on cross-functional teams as well as the US sales team to provide training on on-going support. Since the marketing team is relatively small this is a broadly defined assignment where you will “wear many hats,” so we need a marketing generalist rather than a specialist. A significant element of the job will be to establish strong relationships with Key Opinion Leaders in your segment of the Oncology community and develop them as advocates. You will develop strategies for medical congresses and publications plans, and attend key oncology conferences. Overnight travel is estimated at 25%. We are looking for an ambitious, strategic thinker who has the interest and ability to advance at least two levels above their entry point in the organization. Desired Skills and Experience Qualifications:

8+ years of pharmaceutical marketing experience, including product launch Some supervisory experience is required, along with some experience in a specialty market

(preference is for oncology, but not required) Bachelor's degree or better; MBA preferred Strong presentation and leadership skills and the desire to work in a mid-size drug company where

people get things done without the infrastructure and trappings of Big Pharma The Alpine Group serves only the Medical Technology industry, including the Pharmaceutical, Biotechnology, 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 135 different medical technology organizations hire Impact Players in positions ranging from individual contributor to Chief Level leadership. Our current client list includes large, multinational organizations like Novartis and Medtronic down to small, emerging organizations - including start-ups. The Alpine Group has achieved the MRINetwork’s "President's Club" award for top 20% performing offices each of the past nine years, winning the Regional Office of the Year Award seven times since 1999.

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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 are confident that the recruiting experience you'll have with us will be 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 your company! ***************************************************************************** Apply on company website Principal Medical Editor, Regulatory Documentation Genentech - San Francisco Bay Area Posted 14 days ago Job description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. Principal Medical Editor, Regulatory Documentation The Position Regulatory Documentation is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche's global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Medical Editors are assigned their responsibilities by varying projects as business needs dictate. Medical Editors support the preparation of regulatory documents for submission to regulatory authorities by editing and revising documentation and applying document- and review-related Standard Operating Procedures (SOPs) and other relevant guidelines. Regulatory Documentation uses appropriate tools and systems to prepare regulatory documents and ensure that regulatory documentation fulfills Common Technical Document (CTD) standards. Medical Editors work in close partnership with medical/scientific content owners across relevant functions and share accountability with Documentation Scientists for timely, quality and compliant delivery of regulatory documents. Medical Editors apply editing, document and project management expertise to their work and contribute to functional excellence of regulatory documentation through process management. Principal Medical Editors are typically assigned complex projects or other work to support, are expected to perform their responsibilities with considerable independence, coordinate assigned deliverables and guide these across multiple staff members. DUTIES AND RESPONSIBILITIES:

Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics

Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices

As appropriate, helps his/her manager and/or other departmental management in developing annual and/or long-range business and resource plans for the assigned PDRD team

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As needed or otherwise appropriate, participates in periodic RAFT meetings. Including providing expertise regarding regulatory documentation, guidance on compliance, editing, timelines and other relevant matters

Acts as a resource to project and submission teams; educating others on appropriate content of reports and other deliverables, PDRD processes, Regulatory Submissions processes, etc.

As needed or otherwise appropriate, coaches new document teams on how to write and review submissions most efficiently

Responsible to coordinate and manage the editing and review process of a wide range of clinical/safety documentation

Serves as the editorial contact and liaison between authors, reviewers, Regulatory Publishing, Regulatory Program Management and external collaborators. As needed and in accordance with Standard Operating Procedures (SOPs) and other guidelines, liaises with document contributors to ensure timely and appropriate editing and review. Typically interacts with senior-level internal and external personnel about significant, complex clinical, scientific and statistical matters in documents, often requiring coordination of activity across varying organizational lines

Oversees and coordinates or otherwise substantively edits, rewrites, and proofreads a wide range of clinical/safety documents for submission to regulatory authorities in accordance with regulatory guidelines, Roche standards and SOPs

Oversees and guides or otherwise coordinates the adjudication of review comments with authors and reviewers and provides timely follow-up with regard to outstanding queries or comments until full and final resolution

Represents PDRD in devising solutions to problems with specific documents or submissions Adheres to timelines for review and editing of regulatory documentation to ensure alignment with

overall project timelines. Monitors and helps ensure timely cross-functional reviews and inputs to finalize regulatory documentation and submissions

Responsible to ensure quality, accuracy, completeness, and internal consistency of documents and submissions

Ensures that regulatory documentation is published in collaboration with Product Development Regulatory Operations (PDRO) and that documentation is approved by each relevant single accountable signatory

Provides day-to-day guidance and direction to less experienced Regulatory Documentation staff and their work supporting the same projects and other assignments

Provides and receives direct and objective performance feedback on/from cross-functional teams Desired Skills and Experience

Bachelors Degree required (life sciences, English, or communications disciplines strongly preferred) Advanced Degree in related field is preferred Average of 5-7 or more years' relevant experience in regulatory affairs or related functions in

drug/biologics development/manufacturing. Includes significant experience and competence authoring and/or editing regulatory documentation

Demonstrated clear, high-quality scientific writing style Broad understanding of international regulations, processes and issues in drug/biologics

development. Includes in-depth knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines

Comprehensive understanding of product and safety profiles Familiar with competitive activity in the field Experience participating in global product development or other cross-functional teams is a plus Experience supporting global original IND/NDA/MAA filings and management of filing review

process in the US or Europe is preferred Previous people management (matrix management) experience is a plus Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe

Acrobat Genentech is an Equal Opportunity Employer. ******************************************************************************************************

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http://www.indeed.com/cmp/STAAR-Surgical/jobs/Global-Marketing-Director-Icl-Business-5ee841dbb22c782c Global Marketing Director of ICL Business STAAR Surgical - Monrovia, CA MAIN JOB RESPONSIBILITIES / COMPETENCIES

Global product responsibility, including brand and product marketing strategy, for the Visian ICL products. This includes strategies in both the traditional medical and consumer channels with a special focus on social media and consumer driven strategies.

Manage both the strategic creation and tactical execution of profitable global online marketing campaigns. Establishment and use of metrics to measure effect of spending on product revenues.

Establish good communication channels with the Regional Presidents to assure alignment of all key marketing objectives with regional strategies to achieve success.

Identifies marketing opportunities in the field for existing products and discovers and integrates new trends along with key partners from both a clinical and commercial perspective.

Disciplined use of metrics for the measurement of global promotional effectiveness in order to pursue the optimal approach in the market for STAAR.

Develop and implement strategic and tactical sales plans in conjunction with key market commercial teams.

In cooperation with Clinical Marketing team and surgeons, prepare presentations for key meetings and articles for publication.

Ensure that product pricing strategies deployed by the Company are aligned to the key markets served; provide timely and accurate analysis of data. Track performance to plan, altering tactics as necessary to achieve financial results.

Work with key surgeons to identify and define market and product opportunities for new products/markets to further drive business growth in key markets in line with the overall Strategic Plan.

Prepare a comprehensive marketing plan for products to include a yearly sales forecast for key markets as well as a line-item expense budget.

Prepare and implement products life cycle management strategies in conjunction with the Commercial and Manufacturing teams.

Provide input into R&D projects for the global Visian ICL product line. Coordinate post-approval marketing studies in cooperation with Clinical Marketing Department

to support product sales. Develop and manage all product-training courses for physicians and sales staff. Provide

additional training for Customer Service representatives. Refines ICL marketing processes to ensure continuous improvement of efficiency within the

Marketing group. EDUCATION & TRAINING

B.A. or B.S. degree in marketing, business administration, or directly related field, required. MBA strongly preferred.

EXPERIENCE At least ten years of surgical medical device experience required, ophthalmic refractive or

elective surgery required. Significant experience in the use of social media globally to support branding and drive

product preference through the consumer channels. Strong knowledge of marketing, product branding, positioning, promotion, and pricing. Experience in global marketing required.

SKILLS Strong quantitative/analytical skills with the ability to prioritize growth opportunities based on

financial impact and results. Highly motivated and organized; capable of motivating a team and working independently. Good knowledge of social media and consumer channels and how to effective drive results

through those channels. Ability to strategically plan and demonstrate a positive ROI based on marketing efforts for

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portfolio. Able to work closely with surgeons and sales representatives in a surgical environment. Excellent communication skills and cross-cultural sensitivity. Variety of experience with formal

presentations to executive teams and key stakeholders. Able to travel, air/land, domestically and internationally approximately 20 to 40%. Ability to assimilate information quickly, make decisions and act appropriately in stressful

situations, and make judgments in the best interest of STAAR. Ability to interface with all levels of employees and surgeons in a professional manner.

Proficient computer skills, including word processing, spreadsheets, and presentation development; proficient in PowerPoint. Equal Opportunity Employer M/F/D/V **************************************************************************************************************************************************** For the opportunities below, please send resume at wd_darshana@hotmail.com. Please indicate in the email how closely the job description matches your background and identify gaps, if any. Also, indicate your current compensation and compensation expectations. Please note: All below opportunities require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that). Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs. I am awaiting more job descriptions and will keep adding. Leads appreciated. _________________________________________________________________________ Regulatory Affairs Director – New Jersey There is an immediate opening for Regulatory Affairs Director in a medical device company with innovative treatment of chronic heart failure built around CCM technology. RA Director Will be responsible for RA and for Quality systems. Responsibilities: Domestic & international submissions & approvals for all new & existing products; Assuring compliance with domestic & international quality and regulatory requirements; Assistance with design & implementation of clinical trials to support new & existing products; Represent company with FDA, Notified Body & international regulatory agencies regarding company’s regulatory strategies & submissions; Determine strategy, content & structure of domestic & international regulatory filings & quality assurance strategies; Maintain quality system & current product documentation & labeling in compliance with new standards, directives & requirements; Assist in design & implementation of clinical studies in support of new & existing products. Act as liaison with clinical function; Represent the company with all domestic & international regulatory agencies including all verbal & written communication to & from the company; make all final decisions regarding all Quality System related activities; Review all product complaints & ensure timely reporting of those events to domestic & international regulatory agencies as necessary; Review & revise quality system documentations; Schedule, ensure completion of, manage & respond to all audits; Ensure training of employees on Quality Systems Regulation & key international regulations & standards; Manage the program for handling product returns, returned product evaluations (repair/rework, where applicable), complaints & customer feedback in accordance with internal policies and procedures; Maintain ISO 13485:2012 facility registration in accordance with applicable standards; Participate in product development teams on behalf of Regulatory & Quality Systems; Ensure that the Quality Systems function is carried out in accordance with GMP & ISO directives; Prepare & submit regulatory submissions to obtain approval to conduct domestic & international clinical investigations & to seek regulatory approval to commercialize new & existing devices & their accessories. Requirements: Bachelor in science / engineering with at least 5 years’ experience in Regulatory/Clinical/Quality area or related experience; Regulatory/Clinical/Quality experience with Class 3 medical device; Regulatory experience in the Implantable field – highly preferable; Excellent working knowledge of domestic & international requirements, regulations & standards applicable to medical electrical devices – highly desirable; Proven experience with at least one complete medical device submission to a EU Notified body and the US FDA involving a device subject to the 60601-1 3rd edition standard; Thorough understanding of the MDD (Medical Device Directive); Previous direct interaction with the FDA & an EU Notified Body; Excellent working understanding of requirements & implementation of Quality Systems compliant with US & international requirements for medical device manufacturers; Previous experience assuring that the Quality Systems function is carried out in accordance with GMP &

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ISO directives; Ability to analyze & perform commercial risk management in the context of regulatory & quality requirements. _________________________________________________________________________ Director of Quality Assurance – Palo Alto, CA Details to follow. _________________________________________________________________________ Senior Manager/ Director of Mechanical Engineering – San Jose, CA There is an immediate opening for hands-on Director of R&D Mechanical Engineering in an early stage company developing a novel approach for the oral delivery of large drug molecules. This position will be responsible for building the team and effectively leading multi-project R&D efforts of the organization through technical expertise, interpersonal skills & a clear vision for execution. Stock options and cutting edge technology makes it highly attractive opportunity for the right candidate. Responsibilities: Manage resources to accomplish multi-project product research & development; Provide Mechanical Engineering support to meet R&D objectives; Remain current on developments in field(s) of expertise and industry trends; Actively pursue development of corporate IP; Identify future product opportunities; Develop plans & analyses for execution and review with leadership team; Maintain & update appropriate controlled documentation; Mentor junior staff members. Skills & Experience: Demonstrated leadership of technical teams in medical device field; aptitude for & mastery of Mechanical Engineering principles; problem solving skills in a multidisciplinary environment; Proficient with statistical analysis for engineering and manufacturing; ability to work closely with team members across engineering & non-engineering disciplines such as biochemistry, physiology, pharmacology & chemistry; Knowledge of plastic manufacturing processes including injection molding, thermoforming, casting, machining, extrusion etc.; Knowledge of metals & alloys used in medical devices and processing techniques such as brazing, laser welding & cutting, electropolishing, electroplating, machining etc.; Deep experience in polymer processing, catheter design & fabrication, including knowledge of polymer joining, fusing, die cutting, adhesives etc.; Knowledge of biomaterials & coatings suitable for implantation; Knowledge of packaging & sterilization techniques; ability to interface effectively with professionals in the medical and biological sciences; knowledge of sound design principles, regulatory requirements, and product and process validation procedures; proficiency with computer aided design software & hardware. Formal training on systems & software is desired. Also required: Bachelor’s degree or higher in Mechanical Engineering; 10+ years experience in engineering and product development with demonstrated capability & thorough understanding of the medical device product development process; Three years minimum direct personnel management & related project leadership experience; ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines & develop, monitor and live within budgets as well as ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building. _________________________________________________________________________ QA Testing Manager – Mountain View, CA There is an immediate opening for QA Test Manager at remote health startup that is focused on bringing diagnostics into home use, with a vision to change healthcare. Responsibilities: Define and manage validation and verification processes for medical devices; Analyze validation & verification needs, determines effective strategies & resources, & implement needed processes; Ensure that all work adheres to applicable SOPs, standards & regulations; Take responsibility for forming & maintaining the V&V team and directing the preparation & execution of all work. Requirements: Bachelor’s Degree in a technical field, Biomedical Engineering, Electrical Engineering, Computer Engineering or Computer Science preferred; At least 3 years experience testing against product requirements and tracing tests to product requirements; At least 3 year experience working with design engineers, software, electrical and mechanical engineers and external and internal customers; Experience in working with engineers to design for testability; Experience managing short-term or outsourced testing resources on-site or off-site; Possess requirements & technical documentation preparation & analysis skills; Strong communication, analytical & interpersonal skills. Preferred: Master’s Degree: Biomedical Engineering, Electrical Engineering, Computer Engineering or Computer Science preferred.; Expert in creating, managing, and executing test plans, procedures, and scripts; Expert in manual, automatic, regression, blackbox, whitebox, boundary condition, performance and other standard testing methods;

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Experience working with manufacturing team; Experience using a requirements and test management software system; Experience in leading a V&V team. _________________________________________________________________________ Director Quality Engineering – San Jose, CA There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices. This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution. Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired. Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones. Must be skilled at delegation, follow-up, and team building. _________________________________________________________________________ Patent Attorney – Sunnyvale, CA Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position. Must have 15+ years of medical device and biotech patent prosecution experience in a law firm. _________________________________________________________________________ Software Developers – SF Bay Area (contract, part-time) Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development

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team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment. Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates. Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure. The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships but OPT visa may be ok. Pay: rate negotiable. Open to considering excellent part-time candidates. ******************************************************************************************************************* http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=5811575571582312449&gid=48201&goback=%2Egde_48201_member_5811000304111476736&trk=NUS_DISC_Q-ttle Searching for entry to mid-level candidates for pharmaceutical validation positions Vince RubinoSenior Supervisor, QA Validation at BioMarin Pharmaceutical Inc.

Searching for entry to mid-level candidates for full time, temp or contract pharmaceutical validation positions. Please feel free to forward me LinkedIn profile or resume. Permission to work in the US is required.

******************************************************************** FDA San Francisco District Investigator positions available. Please see link below for more information. Daniel RobertsConsumer Safety Officer (Investigator) at FDA

https://www.usajobs.gov/GetJob/ViewDetails/356001300 ****************************************************************************

Jobs That Crossed My Desk Through Nov. 25, 2013 Tom Wirth Wirth & Associates wirth@wirth-associates.com Director, Scientific Support & Education Responsible for leading the global strategic direction of the customer facing Scientific Support teams, as well as the Education Services team. Typically this will include responsibilities for leading phone/field applications support functions, course development, customer training, technical training, overall Sales & Services talent management and will have indirect responsibility for worldwide science support and education standardization. BS/BA, MS/MA preferred, in a life sciences related discipline is required. Vice President of Operations - J03-1009-T13 Northeast Manage, plan, direct, and coordinate the general operations of the solid dose, generics, manufacturing and packaging.

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The successful candidate must have a minimum of a Bachelors degree. A degree in Engineering, Operations, Logistics, or Life Sciences degree related to the plant functions is required. A MBA is preferred. Senior Management experience is required. Pharmaceutical manufacturing experience is required. Current 10+ years, Solid Dosage experience is required. Sr. Director Engineering - 88-112113-54B CA The Sr. Director Engineering manages and leads the following functional R&D groups: Mechanical Engineering, Engineering Technical Services, Fluid Management Systems Engineering, Reliability Engineering and Electrical Engineering. Engineer - 21B-112013-87B CO - CA - UT - WA Responsible for providing on-site support to . customers that includes, but is not limited to: installation and service of diagnostic instrumentation, after-hours phone support, holiday and weekend on-site support, marketing, exhibitions, and clinical trials support. Director Facilities - 22-112113-89B CA Direct Responsibility for Facilities Management, including project management, maintenance, cafeteria services, and security services. Includes responsibility for budgeting, vendor management, occupant moves, safety for contractor and facilities personnel. Director, Manufacturing - 66R-112013-59N Northeast Manage all aspects of clinical and commercial parenteral drug product filling, labeling and packaging operations for fully integrated biopharmaceutical company. Experience and Required Skills: Requires minimum BS/MS in a scientific discipline with 10+ years of related experience in a biopharmaceutical cGMP environment. Senior Manager Manufacturing Engineering & Project Management - 43-112113-54B West Coast Work with the Cell Analysis senior Instrument Operations leadership team to establish an Instrument Operations strategy. Implement the strategy to achieve business goals by creating and maintaining a Program Management Office to prioritize and track projects. Manage a team of project management/engineering professional dedicated to project delivery directly related to the needs and requirements of Instrument Operations. Automation Engineer - C112013-457 South Central Qualified candidates must have the ability to manage multiple projects, design electgical control systems for utilities, production/packaging equipment and other manufacturing systems. Experience in investigations and non-conformance issues is also very much desired. A BS degree minimum is required along with five to seven years of controls engineering experience. Site Head, Manufacturing, Science & Tech. Transfer - J111913-678 South Central sterile drug manufacturing operation

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BS degree in an Engineering or Scientific discipline, MS/PhD preferred. They also must have a minimum of 15 years sterile drug manufacturing and technical services experience. In addition to base salary and bonus, this position also has Long Term Incentive bonuses and Stock Options. ************************************************************************************ Newest Jobs at JGB BIoPharma Consulting- Week of 11/18 To apply for a position send your resume to Jobs@JGBBioPharma.com Sr. Scientist, Formulation Development – Full Time Position (San Francisco Bay Area) C111PZ DESCRIPTION: Developing and optimizing solid oral dosage manufacturing processes for NCEs, and supervising

process technology transfers and scale-up through validation at contract manufacturing organizations. Supervise the development, optimization and CTM manufacture of early and late stage IR solid

dosage forms (tablets and capsules) of NCEs, providing technical leadership. Report writing, document review and sign-off. Writing to include regulatory documents in support

of submissions. Supervise process development, optimization and scale-up and tech transfers between CMOs.

Includes critical studies through process registration and validation. Hands-on development of solid dosage forms. Maintain a current awareness of and enforce applicable government regulatory, safety,

occupational health, and environmental requirements Characterize prototype formulations, conduct pre-formulation studies and support development of

corresponding analytical methods. Evaluate the potential for enhancing oral bioavailability of lead drug candidates through application

of state of the art formulation technologies Work closely with other Research and Development teams, actively supporting testing of new drug

formulations at various stages of development, meeting project timelines and goals Present formulation development results at meetings and in technical reports and publications Represent the formulation group in various inter-disciplinary settings Track record of NDA CMC sections, and corresponding supporting technical documents and

development reports Maintain a current awareness of formulation and delivery technologies. EXPERIENCE AND QUALIFICATIONS: Significant direct experience in (IR) solid dosage formulation and process development,

optimization and scale-up of NCEs, utilizing statistical designs of experiments A working knowledge of ICH and FDA guidelines Working knowledge in analytical techniques used for testing, characterization and in-vitro

comparison of solid dosage forms Prior experience designing pre-formulation and stability studies for small molecule oral

formulations Demonstrated ability to efficiently manage contractors and to build and maintain excellent working

relationships with outside parties Excellent written and verbal communication skills A self-directed team player able to work in an interdisciplinary, fast-paced environment Prior experience working in a GMP environment Willing to travel to meet project needs A Ph.D. in Pharmaceutics, Pharmaceutical Chemistry, Chemical Engineering or a related field A minimum of 10 years of small molecule oral formulation development experience in the

pharmaceutical/biotech industry Shared Services Associate – Contract (Southern California) 73X9170 DESCRIPTION:

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Works within the employee phone call center to serve as an initial point of contact for tier one employee questions through phone and email case tracking.

Obtain Human Capital Management system knowledge to complete various transactional requests and provide advice and counsel to employees, managers and HR Generalists as to the best way to utilize the system to complete self service tasks.

Develop broad base of knowledge with respect to HR processes and protocols. Answer basic HR-related employee questions via email and phone and track inquiries in case

tracking system. Respond to inquiries and resolve any issues in line with key performance indicators (KPIs) and

Service Level Agreements (SLAs). Run pre-defined system queries/searches. Work directly with employees & managers to obtain or complete required paperwork and

coordination with managers and other departments to make sure related employee services are in place.

Maintain employee files. Participate in and contribute to assigned HR function projects as needed. EXPERIENCE AND QUALIFICATIONS: Functional knowledge of corporate operations and familiarity with HR industry practices.

Transactional knowledge of HRIS systems (i.e. Workday, SAP, PeopleSoft) and HR functions and processes.

Proficiency with Microsoft Outlook and Office (Word, Excel, PowerPoint), as well as Adobe Acrobat, and other commonly used applications.

Demonstrated ability to maintain confidentiality and handle sensitive situations with solid judgment and discretion is critical.

Exceptional interpersonal and communication (written and verbal) skills. Must be able to successfully interact with various levels within the organization.

The incumbent must possess self-motivation, enthusiasm, and a positive demeanor toward the job, the company, and their work team. Organizational, leadership, and project management skills are also necessary to be successful in this position.

Two (2) years of related experience working in a HR Support or HR administration experience in a corporate and or Shared Service environment

Broad HR background with the ability to analyze complex issues and apply creative solutions. Familiarity with applicable state and federal regulations.

Bachelor's degree from accredited college/university or equivalent experience. Associate Scientist I - R&D – Contract (San Francisco Bay Area) 73N4513 DESCRIPTION: Duties are in line with general tasks performed by an R&D bench scientist. Conduct pre-designed scientific or engineering experiments in a molecular biology laboratory. Plan the use of equipment, materials and own time. Accuracy is required in performing all functions of this position. Make detailed observations and perform basic data analysis. Maintain complete and thorough lab notebook and training file. Advise team of factors that may affect quality, accuracy, timeliness and usefulness of data. Suggest options / ideas for additional experiments. Troubleshoot experiments with assistance from team. Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols,

processes and equipment. Assist in lab procurement, calibration or maintenance. Comply with all company safety regulations and procedures. With team’s guidance, become familiar with scientific processes and molecular mechanisms directly

associated with the assigned project. May be required to perform other related duties as required and/or assigned. Position exercises judgment within defined procedures and practices to determine appropriate

action.

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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. EXPERIENCE AND QUALIFICATIONS: Must have experience in molecular biology research including general molecular biology techniques,

including following protocols, pipetting, quantifying DNA, calculating molarities, setting up reactions and PCR.

Must have ability to perform experiments with high precision and accuracy. Must have experience accurately recording data, interpreting data, keeping a lab notebook, and

reporting results. Must be an effective team player with strong spoken and written communication skills. Must be familiar with standard office software tools (Microsoft Word and Excel, or equivalents). Experience with TaqMan or other quantitative-PCR methods is desirable. Experience with genotyping is desirable. Experience with basic statistical methods is desirable. Bachelor's degree in Biology, Chemistry, Biochemistry or other related discipline or the equivalent

knowledge and experience. Lab Tech - R&D – Contract (San Francisco Bay Area) 73G4581 DESCRIPTION: Clean, operate and maintain DNA sequencing instruments (PGM and Proton). Conduct pre-designed scientific or engineering experiments using laboratory equipment and

calculations. Plan the use of equipment, materials and own time. Assist in lab procurement, calibration or maintenance. Aware of New Product Introduction process and impacts business opportunities through successful

task completion. Make detailed observations and basic data analysis. Maintains accurate lab notebook, & training file in accordance with division standard. 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. Comply with all company safety regulations and procedures. Report non-compliance and may serve as team lead. With supervisor’s guidance, become familiar with literature directly associated with assigned

project and transmit information gathered to other members of the scientific team. May be required to perform other related duties as required and/or assigned. 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. Disciplined routine is needed for prompt and reliable completion of tasks. EXPERIENCE AND QUALIFICATIONS: Accuracy is required in performing all functions of this position BS in biology or related scientific field. Production Scientist – Contract (New York) 1969Z73 DESCRIPTION: Carry out standard operating procedures involving materials measurement, materials handling and

inventory control, equipment operation and record keeping necessary to manufacture product batches as instructed.

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Record keeping includes but is not limited to Batch Data Records, notebooks, customer reports and work order documents.

Maintain accurate inventory of products and inventory records using the Materials Resource Planning tools (i.e. issuing materials to work orders, completing products to inventory, kitting, closing, transfers, returns, expensing of raw materials, WIP and finished product).

Complete production and quality analysis of reagents, components and finished products in accordance with the Production Schedule.

Communicate manufacturing problems to manufacturing management and the team and assist in identifying variables and offering resolutions.

Keep manufacturing supervisors and team members informed on the status of assigned production processes.

May train other team members on techniques and processes. Complete all batch data records completely, according to Quality Systems standards as required. May perform other related duties as required and/or assigned. Interacts with equivalent levels of personnel in the manufacturing area. Effectiveness in this role requires a functional knowledge of applicable manufacturing process and

Standard Operating Procedures and the ability to consistently and accurately follow procedures. The job encounters semi-routine work situations of limited scope and complexity where ability to

recognize deviation from accepted practice is required. The incumbent normally receives general instructions on routine work and detailed instruction on

new assignments. EXPERIENCE AND QUALIFICATIONS: Good oral and written communication skills are required to communicate work status and

problems. Accuracy is required in performing all functions of this position; errors in work could cause delays

in schedules and impact to product quality / customer satisfaction. This position requires at least four (4) years of demonstrated experience in the use of learned

laboratory and production techniques with a variety of equipment and materials in a regulated manufacturing environment.

Computer literacy, including spreadsheet, database, word processing, and internal applications/systems are required.

Usually works in an office and laboratory/manufacturing facility with specialized equipment. Bachelor’s degree in Biology, Chemistry, Biochemistry, or other related discipline required, or the

equivalent knowledge and experience. Business Analyst – Contract (Pennsylvania) 4881 DESCRIPTION: Validation of all incentive compensation reporting and calculations. Process, validate, and distribute weekly performance reporting to sales force and management. Maintain database for IC plan signoffs, including tracking and notification. Process, maintain and validate the PTPA distributor data via Access database. Provide backup and help to Incentive Compensation team members in support of team duties and

objectives. This includes, but is not limited to: preparation of trackers; validation of compensation documents; quota workbook preparation and documentation; processing of MicroStrategy validation reports; and ad-hoc MicroStrategy reporting.

Other duties as assigned. EXPERIENCE AND QUALIFICATIONS: Must be organized and analytical. Must maintain a high level of data accuracy and must be detail oriented in validation. It is critical to adhere to timelines to achieve success. Background in finance or compensation is a plus. 2 to 4 years experience with a strong analytical skills with complete understanding of spreadsheet

principles (Excel) and statistical fundamentals. Knowledge of MicroStatagey and database management a plus. BA/BS, Business or Finance background preferred, however associates with strong relevant

experience considered.

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************************************************************************************ Jobs That Crossed My Desk Through Nov. 17, 2013

******************************************************************************* Please submit your CV, and a cover letter with an example of a decision you influenced within your organization via your interpersonal skills to: careers@principabio.com. CV’s submitted without a cover letter will not be considered Research Scientist / Sr. Scientist DMPK - SSF @ Principia Biopharma Title: Research Scientist / Sr. Scientist DMPK - SSF Principia Biopharma is a biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and inflammation. As such, Principia Biopharma is comprised of a team of exceptionally talented scientists and business leaders. Our employees experience transparent communication, and the sharing of ideas in an environment of mutual respect. We’re seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and will contribute to DMPK studies at the project team and department level to support discovery and development programs at Principia. The candidate will also manage external CROs to deliver high quality results within project timelines. A more complete description of the position, and experience required, is listed below: Job Description We are currently seeking a seasoned DMPK professional who will be responsible for executing small molecule DMPK analysis. You will design, conduct and analyze in vivo DMPK studies to support our drug discovery and development projects. You will be responsible for PK parameter calculations and interpretations, making strategic suggestions in team settings, and contributing to PKPD assessments on our programs. Computational modeling for PK parameters and PK projections will be required. You will be working closely with scientists in Pharmacology on PKPD evaluations. You will oversee and manage CROs to timelines as well as communicate results from such collaborations. You are expected to interpret bioanalytical/pharmacokinetic findings, write reports (including regulatory filings), make presentations, participate in project team meetings and communicate at a high level with internal and external scientists. Qualifications PhD degree with 5 years of industrial experience or BS/MS degree with 10+ years industrial experience is required. Stellar presentation and communication skills are essential. You must have solid knowledge and demonstrated hands-on experience in preclinical and clinical (desirable) DMPK. You will have experience applying DMPK concepts to drug discovery and drug development in department and project team settings. Additional skills in analytical chemistry using HPLC and LC/MS/MS are desirable as are automation/work flow process improvement experience. Good organizational and record keeping a must. Enthusiastic and motivated team player with a can-do attitude is required! . Principia Biopharma, Inc. is an equal opportunity employer Laura Doehle | Director of Client Services Resourceful HR, LLC San Francisco | Seattle ********************************************************************************** If you wish to work with Complete Genomics, please contact the Human Resources department at careers@completegenomics.com. Flow Slide Manufacturing Technician @ Complete Genomics, Inc. in Sunnyvale Location: Sunnyvale, CA Contract Job Code: 13-PD-121 Associates Degree The flow slides manufacturing technician is an enthusiastic, highly motivated person with great communication skills who can support the production of semiconductor-based flow slide device used in high-throughput genomic sequencing. The successful candidate will demonstrate the ability to perform a variety of production processes which include vacuum and wet processing, visual inspections, and mechanical assembly. The candidate must be willing to work in a dynamic environment in which production is ramping while processes are being improved. In addition, the candidate should desire to work in a team setting where they will actively contribute to improving the production process.

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Essential Job Duties and Responsibilities: • Perform daily production processes including wet processing, chemical vapor deposition, resist coating, mechanical assembly, and visual inspections using high powered microscopes • Perform PM on processing equipment • Support development team on an “as needed” basis to perform basic tests and non-standard processing • Assist with laboratory support activities such as disposal of hazardous waste, safety audits, replenishing Kanbans • Actively participate in continuous improvement program Requirements • Associates degree or equivalent • 8 years’ experience in industry (semiconductor, telecom, or magnetic recording) • Experience using high-powered microscopes for both bright and dark field visual inspections • Good verbal and written communication skills • Experience with data collection (familiarity with Excel, data entry, basic statistics, control limits, and SPC) • Experience with MES (Manufacturing Execution System) preferred but not required • Knowledge of Lean Manufacturing best practices preferred but not required Complete Genomics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Complete Genomics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Complete Genomics and will be processed accordingly without fee. Complete Genomics has the sole discretion to determine with whom we will enter into a contract. ************************************************************************* Job Opening: Regulatory Affairs Manager Medical Device, Acclarent (Johnson&Johnson) Menlo Park CA Steve Rabin Pharmaceutical CMC Regulatory Leader | Drug and Device Product Development Contact me if you're interested. Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent continues to advance novel devices in all areas of ENT. The Regulatory Affairs manager contributes to the advancement of Acclarent products by enabling access to diverse markets through a variety of regulatory marketing applications and by close participation with product development teams. The Regulatory Affairs Manager position provides the opportunity to bring Acclarent’s innovative technology to physicians worldwide. The Regulatory Manager is responsible for review of product labeling, supporting project teams, compiling US and International regulatory submissions, and providing guidance on advertisement and promotional materials. The Regulatory Manager is responsible for providing regulatory support for Operations and/or Product Development projects and develops and implements global regulatory strategies to further the work of the

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project team. The Regulatory Manager prepares, manages, and submits FDA (Pre-Sub, 510(k), IDE, PMA) submissions. The Regulatory Manager also prepares and submits Technical Files and related documentation in support of EU device registrations, and will work with J&J Affiliate organizations to prepare and submit other non-US regulatory submissions for approval. The Regulatory Manager ensures compliance with all applicable U.S. and International regulatory requirements, with special emphasis on ensuring the accuracy and regulatory compliance of product labeling, such as Instructions for Use, device labels, and in the review of advertisement and promotional materials. The regulatory professional in this position reviews and approves design and manufacturing changes,test protocols and reports, and other important documents to ensure compliance with applicable regulations and filing requirements. The Regulatory Manager also works closely with Clinical Affairs professionals to support ongoing pre-and post-market studies. The Regulatory Manager will share responsibility for continuous review and improvement of relevant SOPs and work instructions, and may be called upon to provide prompt review adverse event reports and similar compliance-related submission documentation as needed. The Regulatory Manager must be capable of communicating detailed regulatory strategies to project team members and provide regulatory guidance as necessary. The Regulatory Manager must be able to communicate directly with regulatory agencies including the notified body and FDA. The Regulatory Manager will share responsibility in communicating with senior management, providing highlights and updates on status of projects as necessary. A minimum of B.A. or B.S. degree or higher is required. Applicant must have a minimum of 5 years experience with medical devices, Class 1 & 2 required, Class 3 preferred. Must exhibit knowledge of FDA regulation of medical devices. Experience writing FDA premarket submissions and communicating directly with CDRH or other FDA divisions is required. Experience working with CDER and OCP is a plus. The RA Manager candidate must have excellent communication and presentation skills, and be prepared to thrive in a complex and fast-paced environment. ************************************************************************************ Details on these and other opportunities, can be seen in JOBS category at www.darshanavnadkarni.wordpress.com. If interested, please send resume as an attachment to wd_darshana@hotmail.com. Please mention the job opportunity in the subject line and mention in the email how closely it matches your background. Director of R&D (ME background) San Jose, CA - Initially 90% of work will be as individual contributor, as you build the team. This is an opportunity to get involved at grounds level in disruptive technology, with huge market potential. Requires Class III medical device experience and experience with electro-mechanical systems. _______________________________________________________________________________ Director of Quality Engineering - San Jose, CA. -- Same as above. Quality Test Manager - Mountain View, CA Recently funded remote health monitoring company developing diagnostic apps. _______________________________________________________________________________ Director of Electrical Engineering - Texas --- Requires experience with ultra low power devices and electro-mechanical implantable devices. _______________________________________________________________________________ General Manager of Software Development - Pleasanton, CA. _______________________________________________________________________________ Head of Molecular Analysis - Mountain View, CA _______________________________________________________________________________ Laboratory Director - Taiwan, Taipie -- This is an opportunity to shine in a leadership role and do a short stint in Asia. ***********************************************************************************

To apply for one of the positions below, send your resume to Jobs@JGBBioPharma.com

12/8/2013 48

Quality Control Technician – Contract (Maryland) 73F0337 DESCRIPTION: Perform release inspections of product in a regulated environment Review batch records and perform release transactions Inspect shipments and perform other QA functions as necessary EXPERIENCE AND QUALIFICATIONS: Batch release experience Experience with product Inspections QA experience High School / College

Procurement Professional – Contract (New Jersey) 0351 DESCRIPTION: Procurement Fully manage transactional activities for low value, low risk and non-repetitive purchases under a given threshold. Ensure compliance with local contract approval policies and spend management strategies; function as process path gatekeeper. Review all purchase requisitions for data entry for accuracy and compliance. Responsible for the correction of any transmission errors of the purchase order. Responsible for compliance with each step of the local procurement process and policies Perform SOX controls. Level 2 Issues Resolution. Assist end users with data entry, completion of the purchase requisitions, and purchase order revisions. Interact with suppliers in case of issues related to the receiving of goods and services (quantity, quality and late delivery management) and communicate with sourcing (feedback). Interact with accounts payable regarding any purchase order issues with payment of the invoice. Perform monthly order reconciliation / ensure payment terms are met Issue and dispute resolution. SOX Documentation filing requirements. AP / Controller requests. Procurement policies and best practices. Interface as needed with internal customers, suppliers, buyers, department in charge of technical support for SAP/NEXTS (if applicable), finance department, accounting department. Contract Create and manage Contract Workspace contents and tasks in NEXTS including entering of pricing terms from sourcing events, selecting appropriate templates, following policies and procedures in determining the routing of contracts, facilitate the contract approval process and work with business owner to facilitate contract execution. Monitors the progress of contracts through the contract process and all phases through contract completion. Manage all contract publishing process including scanning retrieval and uploading of executed contracts into NEXTS and communicates PO reference number to internal and external customers. Ensure compliance with several different local contract approval policies and spend management strategies; function as process path gatekeeper and reviews all contract requests against local Contract Approval Policies Maintain the accuracy and consistency of contract information. Performs SOX controls (review Contract Approval Policy, Delegation of Authority of contract signatories and compliance with records retention policies), and support compliance as needed. Obtain appropriate documentation for supplier set-up. Generate various reports and status updates as needed. Liaison with business owner and suppliers for issue resolution. Deal with confidential information. Assist/support buyers upon request for sourcing activities to perform RFP transactional tasks when appropriate including data entry , documentation support, and project close out activities

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Customer Support Analyst – Contract (New Jersey) 9721 DESCRIPTION: Analyze incoming orders that are held up in intermediate document (IDOC) status to identify the issues and take appropriate action to release it. Issues could be a combination of pricing, quantity, incorrect unit of measure, etc. Monitor orders to ensure smooth transition throughout order journey Review and take appropriate steps to resolve all system blocks, i.e. DEA review of orders with controlled substances, review of short-dated requests, etc. Perform complex SAP transactions to ensure timely processing of orders to meet company goals and customer expectations.

EXPERIENCE AND QUALIFICATIONS: Knowledge of order to cash Analytical and problem solving skills Knowledge of SAP navigation & logic Intermediate to advanced level Microsoft Excel experience required. Knowledge of Microsoft Office Suite Excellent interpersonal and communication skills, both verbal and written Self-starter with ability to work in team environment and foster cross-functional collaboration Ability to work effectively and efficiently in a fast-paced environment Exhibit a high level of professionalism Self motivation and proactive work approach Excellent organization skills Ability to research, analyze and interpret data and make recommendation to management Bachelor Degree plus 1-3 year(s) experience

Packaging Technician – Contract (Pennsylvania) 1318 DESCRIPTION: Responsible for activities supporting the primary and secondary packaging, labeling, and assembly, warehousing, and shipping preparation of investigational drugs used in various clinical studies. Sign and date batch records for activities performed on all supplies prepared for clinical investigation and verify the work of other production staff members. Work is assigned and reviewed by Packaging Supervisor, Production Supervisors, Warehouse Supervisor, and/or Team Leaders. Instructions will be in the form of written batch records as well as verbal instructions. EXPERIENCE AND QUALIFICATIONS: Must be detailed oriented, dependable, and able to work independently and also in a team environment. Must have the ability to read, especially small and repetitive text patterns and the ability to follow numeric sequences and perform accurate counting. High school diploma or equivalent is required.

Copy Editor – Contract (Southern California) 8646Y73 DESCRIPTION: Strong copy editor with an eagle eye for detail, a good sense of humor, and a will-do attitude. Team supports a large internal client base with needs ranging from ads to emails, brochures to flyers, and billboards to banners. This position will handle overflow copy editing/copywriting for a high volume of these types of pieces under short timelines. EXPERIENCE AND QUALIFICATIONS: Strong copy editing/copywriting background and ability to deliver concise content that adheres to brand style guidelines; ensures correct trademark usage, grammar, punctuation, etc.; and upholds a consistent approach across all marketing materials Ability to distill complex technical/scientific information into effective value-driven messaging Expert knowledge of Chicago style Preference for and ability to thrive in a fast-paced, dynamic environment

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Excellent collaboration and customer service skills Science background a plus, but not necessary Understanding of marketing best practices Exceptional attention to detail and high regard for quality BS in English, journalism, marketing, advertising, or related field and 5+ years of copy editing experience

Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q DESCRIPTION: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs Independently oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects. Initiates and participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents. Oversees and works directly with CROs, vendors, investigators, monitors and other external partners. Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact study-level status updates. Leads and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set-up, CRFs, regulatory documents, and site contracts in conjunction with relevant departments. Supports and coordinates tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors. Supports CPM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock. Conducts Trial Master File review and line listing data review

EXPERIENCE AND QUALIFICATIONS: Experience: 7-10+ years clinical research experience in a pharmaceutical/biotech, CRO setting, monitoring experience Phase 3 experience strongly preferred Immunology or Oncology clinical trial experience preferred Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials Strong interpersonal, organizational, and multi-tasking skills Able to work independently Excellent attention to detail and problem solving skills Ability to work effectively work in a team setting Travel domestic – up to 25% Science background BS or healthcare degree required, Masters preferred

Administrative Assistant – Contract (Pennsylvania) 6864 DESCRIPTION: Administrative support for Senior Director,Technical Services as well as his leadership team members: Manage calendars in Microsoft Outlook, set up meetings, secure conference rooms, and reserve audio/visual equipment Document meetings, publish meeting minutes and action items Prepare reports, letters, memos, presentations and other documents Develop monthly reports for Maintenance Coordinate travel and complete expense reports Input of purchase requisitions and check requests Assist with special projects. i.e., data input Maintain audit inspection records, training records, vehicle records, department bulletin boards and follow-up files for Managers.

EXPERIENCE AND QUALIFICATIONS:

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Must have the ability to multi-task, work with others including all levels of leadership, be compliant with Corporate and FDA requirements, and continuously build relationships with the customers to understand their needs and provide First Class Service. This position requires the incumbent to perform administrative services for all aspects of the Technical Services Department, with many directly affecting GMP areas and environments. The GMP production environment requires attention to the details and accuracy within good documentation practices. 3+ years of professional administrative support experience in a similar role, with considerable experience and knowledge working with Microsoft Office Suite including Word, Excel, Outlook and PowerPoint. Must be a detail oriented, self-starter with excellent organizational and time management skills. Must also have excellent written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams. Associates Degree preferred

Customer Support Analyst – Contract (New Jersey) 9721 DESCRIPTION: Analyze incoming orders that are held up in intermediate document (IDOC) status to identify the issues and take appropriate action to release it. Issues could be a combination of pricing, quantity, incorrect unit of measure, etc. Monitor orders to ensure smooth transition throughout order journey Review and take appropriate steps to resolve all system blocks, i.e. DEA review of orders with controlled substances, review of short-dated requests, etc. Perform complex SAP transactions to ensure timely processing of orders to meet company goals and customer expectations.

EXPERIENCE AND QUALIFICATIONS: Knowledge of order to cash Analytical and problem solving skills Knowledge of SAP navigation & logic Intermediate to advanced level Microsoft Excel experience required. Knowledge of Microsoft Office Suite Excellent interpersonal and communication skills, both verbal and written Self-starter with ability to work in team environment and foster cross-functional collaboration Ability to work effectively and efficiently in a fast-paced environment Exhibit a high level of professionalism Self motivation and proactive work approach Excellent organization skills Ability to research, analyze and interpret data and make recommendation to management Bachelor Degree plus 1-3 year(s) experience

Document Control Specialist – Contract (Texas) 9027H73 DESCRIPTION: Individual will be transferring data to template form. Must be comfortable with and familiar with QC. Will be working under supervision but will be required to produce and work well in a faced paced environment. EXPERIENCE AND QUALIFICATIONS: Conducts all activities in a safe and efficient manner Good organizational skills and attention to detail reliability. Must have excellent interpersonal skills, writing skills, and communication skills. Individual must work well with others, in a positive, collaborative work environment May be required to perform other related duties as required and/or assigned. BS with 1-2 years of experience in QC or Biotech environment or AS with 3-5 years.

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Accountant II – Contract (New Jersey) 2759 DESCRIPTION: Responsible for GRIR analysis and clearing Perform GRIR analytic assessments (aging, blocked invoices) Work cross-functionally and liaison with Controlling, Procurement, Procurement Operations Shared Service, Accounts Payable and Business Owners surrounding GRIR clearing requirements or issues (invoice remediation, quantity/price variances) Adhere to best practices surrounding GRIR controls, roles and responsibilities and process flow Support the development of relevant training for Finance, Purchasing, Procurement Ops shared services, and Business Performs all related SOX controls Obtain all appropriate required documentation Generate various monthly reports and status updates as needed

EXPERIENCE AND QUALIFICATIONS: Experience must include knowledge of accounting, sourcing, procurement and contract management Understanding of contracts and business, legal & financial terms and conditions CPA preferred Excellent understanding of Procure to Pay process including financial, accounts payables and procurement process and systems (SAP, Ariba) Proficient in Excel, pivot tables, and VLookup. Access/Database knowledge a plus. In dept knowledge and understanding of project, contract, and PO lifecycle management of spending Solves and works independently and with team to solve complex problems Ability to be work efficiently under pressure with little supervision, deliver high level of customer service and proven track record of following through with assignments meeting strict deadlines Ability to adapt and drive change, begins new tasks, assumes responsibility and makes decisions in line with process assessment Qualified candidate should possess excellent organizational skills and a systematic approach to work with care taken over detail and due regard to confidentiality Must possess efficient analytical skills; attention to detail, diligently follow up on many items that are simultaneously in various stages of completion Plans, prioritizes, organizes and completes work to meet established objectives Ability to prioritize and manage multiple projects simultaneously Must a be a self-starter - have a high degree of personal initiative Strong interpersonal skills Flexible disposition, effectively demonstrates competencies Bachelor’s degree from an accredited four-year college or university area of specialization, and five plus years of relevant work experience. Audit background a plus.

Creative Services Scheduling Coordinator – Contract (Southern California) 3668M73 DESCRIPTION: Responsible for supporting the Creative Services Schedulers in the resourcing, scheduling, and trafficking of all creative projects initiated by internal business partners, ensuring that all work is completed accurately and on deadline through the establishment of proper timelines. Create custom schedules as directed by the Scheduler based on the agreed upon deadlines and workflows. The ideal person will be skilled at performing in a high-volume deadline-driven environment. Creates timelines for creative projects, assigning resources and determining hand-offs as directed by the Scheduler. Effectively communicates and enforces production schedules and deadlines, managing the timely adherence to established deadlines. Generates and maintains daily priority list for the creative services team. Assists as day-to-day liaison between Scheduling Team, managers and creative team members and/or external agencies and vendors, providing updates on job status, clarifying questions, and troubleshooting problems.

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Analyzes workload in terms of project quantity, complexity and deliverables due dates to predict resource needs. Develop sound and effective solutions to issues and problems that impact a project deadlines. Resource management and allocation of projects based on the individual strengths/weaknesses of the team. Ensures all project files are saved in management tool.

EXPERIENCE AND QUALIFICATIONS:

Some traffic experience preferably in an advertising agency environment or in house creative team preferred. The ability to manage all aspects of creative production– from project inception to completion. Strong problem-solving and decision-making skills with the ability to analyze alternative solutions and prioritize quickly within tight deadlines. Detail oriented with the ability to work in a fast-paced, deadline driven environment, managing multiple projects at once with little or no supervision. Experience using Marketing Communications project management systems preferred. Ability to work with and take direction from multiple people effectively and prioritize using best judgment. Strong initiative and customer service focus. Excellent oral and written communication and interpersonal skills. Demonstrated proficiency with Microsoft Office suite. 4-year college degree. Degree in Marketing preferred.

Engineering Technician – Contract (Texas) 73Y9434 DESCRIPTION: General maintenance of equipment as assigned Troubleshoot and repair HVAC systems/electrical Maintaining accurate records Scheduled and unscheduled equipment repairs General custodial duties Reporting equipment or building issues as they arise Stocking supplies and maintaining inventories Purchasing equipment and supplies Support to other departments Centron installations and programming Surplus inventory maintenance Moving furniture and equipment Other duties as assigned. EXPERIENCE AND QUALIFICATIONS: Requires strong analytical skills with through knowledge of best industry practices. Well versed in maintenance operations, computerized maintenance and energy management systems. Requires excellent project management skills. Familiarity with major trades are essential including ,heating, ventilation, air conditioning (HVAC), plumbing and electrical. Interpersonal skills and PC skills are essential. Must have sound judgment and ability to prioritize work. Customer focused. EPA licence is required. 8+ years direct maintenance or trade experience

Scientist – Contract (Wisconsin) 73W4257

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DESCRIPTION: Performing assays, analyzing data, synthesizing comprehensive reports. Contribute to a project designing and executing experiments for HLA genotyping Synthesizing complex data into technical reports Communicate results; follow GMP and QSR compliance guidance. EXPERIENCE AND QUALIFICATIONS: Handling DNA samples; PCR; PCR purification; DNA sequencing; and/ or genotyping Analytical and detail oriented Great follow through, interpersonal relationships Takes initiative, resourceful, independent. Minimum Bachelor's Degree in Molecular Biology, Biochemistry, Immunology. Three years of lab/industry experience preferred.

Sr. Cost Accountant – Contract (San Francisco Bay Area) 9678G73 DESCRIPTION: Perform the month-end closing process for manufacturing/operations. This includes inventory account reconciliations, analysis of work order variance & purchase price variances, and review of inventory in transit. Prepare, enter, and post journal entries. Evaluate journal entries for completeness and accuracy. Research and resolve any reconciling items on a monthly basis. Assists in maintenance of documentation of policies, procedures and controls. Support the annual cost roll of inventory parts. Validating the primary site allocation, validate make-or-buy decisioning and validate cost roll components such as purchase price, bill of materials and routings for selected inventory parts. Daily data maintenance process to create and complete views for new inventory parts (view extensions) including validation if all costing/accounting views have been updated correctly before allowing new product release for sales. Support the implementation of the best in class processes and accounting practices. Execute ad-hoc requests, tasks and projects as they come up. EXPERIENCE AND QUALIFICATIONS:

Must be able to understand data at a high level and capable of working with large amounts of details Accuracy is required in performing all functions of this position. Good written and oral communication skills are required Must be able to cooperate effectively with different functions with the company, such as buyers/planners, product managers and accounting team. Requires a functional knowledge of manufacturing and cost accounting. Initiative and organization skills are extremely valuable to ensure a smooth office operation. Must possess self-motivation, enthusiasm, a positive attitude and ability to perform as a team player Proficiency in Excel, SAP, and Hyperion Essbase is required. Proficiency with JD Edwards is a plus. Bachelors Degree in Accounting required; CPA preferred but not required

To apply for a position send your resume to Jobs@JGBBioPharma.com. A point of contact is Gennifer Vega at gvega@jgbbiopharma.com Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q DESCRIPTION: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs Independently oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects. Initiates and participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents. Oversees and works directly with CROs, vendors, investigators, monitors and other external partners.

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Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact study-level status updates. Leads and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set-up, CRFs, regulatory documents, and site contracts in conjunction with relevant departments. Supports and coordinates tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors. Supports CPM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock. Conducts Trial Master File review and line listing data review

EXPERIENCE AND QUALIFICATIONS: Experience: 7-10+ years clinical research experience in a pharmaceutical/biotech, CRO setting, monitoring experience Phase 3 experience strongly preferred Immunology or Oncology clinical trial experience preferred Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials Strong interpersonal, organizational, and multi-tasking skills Able to work independently Excellent attention to detail and problem solving skills Ability to work effectively work in a team setting Travel domestic – up to 25% Science background BS or healthcare degree required, Masters preferred

************************************************************************************ There are over 400 jobs listed for California at BIO’s jobs list See others at BIO Jobs at http://jobs.bio.org/jobseeker/search/results/ where you can search by state, industry (e.g., medical device, biotechnology, biopharmaceutical, diagnostics, chemistry, etc.) See example of two jobs listed but then a running list of jobs listed since Nov. 1 from biopharma, biotech, diagnostics and medical device. http://jobs.bio.org/jobseeker/job/15470353/Chemistry%20Analytical%20Chemist%20(1534_0010791144-01-1)/__company__/?vnet=0&max=25&t735=120 Chemistry Analytical Chemist (1534_0010791144-01-1)

Job ID: 15470353

Position Title: Chemistry Analytical Chemist (1534_0010791144-01-1)

Company Name: Gen-Probe Incorporated

Job Function: Science

Location(s): San Diego, California, 92101, United States

Posted: November 3, 2013

Entry Level: No

Job Type: Full-Time

Min Experience: None

- See more at: http://jobs.bio.org/jobseeker/job/15470353/Chemistry%20Analytical%20Chemist%20(1534_0010791144-01-1)/__company__/?vnet=0&max=25&t735=120#sthash.LcXdvRZM.dpuf Chemistry - Analytical Chemist CHEMISTRY Analytical Chemist - Methods Development (#AM-0115) in San Diego, CA. Submit resume w/ Job# by mail only to Gen-Probe Inc., Attn: HR, Job #AM-0115, 10210 Genetic Center Dr., San Diego, CA 92121. . Additional Info: Biotechnology. Biotechnology. Research & Dev. Full Time. Desired Experience: Not specified. acdc:1534_0010791144-01-1 - See more at: http://jobs.bio.org/jobseeker/job/15470353/Chemistry%20Analytical%20Chemist%20(1534_0010791144-01-1)/__company__/?vnet=0&max=25&t735=120#sthash.LcXdvRZM.dpuf

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-_________________________________________________________________________________________________ Apply at http://pcijobs.applicantpro.com/jobs/54176.html Senior Calibration Technician

Job ID: 15600480

Position Title: Senior Calibration Technician

Company Name:

Pharmaceutical Calibrations and Instrumentation, LLC

Job Function: Other

Location(s): Los Angeles, California, 90045

Posted: November 14, 2013

Entry Level: No

Job Type: Full-Time

Min Education: BA/BS/Undergra

- See more at: http://jobs.bio.org/jobseeker/job/15600480/Senior%20Calibration%20Technician/__company__/?vnet=0&max=25&t735=120#sthash.VwCHc0QN.dpuf PCI is hiring a Senior Calibration Technician in Los Angeles, CA. The Senior Calibration Technician reports directly to the Team Leader, Manager, or Director depending on the organizational structure. These positions are non-exempt. Thirty percent travel may be required. Responsibilities/Assignments: • Oversees and supervises calibrations, qualifications, and PMs with accurate and timely GxP documentation, ensuring all Team members follow PCI or client specific policies and procedures, and in a safe manner. • Provides guidance, direction and effective solutions to clients and PCI technical resources. • Upholds, mentors, and is a role model to other PCI Associates on the PCI philosophy and values through honesty, integrity, self motivation, teamwork, pride and commitment. • Proactively takes steps to ensure PCI and client owned equipment is handled and maintained properly, as well as trains other Associates on proper use and handling. • Develops client quotes and proposals. • Provides oversight and project planning including time codes, schedules, test equipment, documentation, and ensures client requirements are met. Also responsible for ensuring accurate and timely scheduling, resource allocation, proposal and quotation development, Labor Utilization Reports (LURs), fixed cost and T&E project management for profitability. Must have the ability to identify scope changes and communicate to client, as well as, process the scope change request documentation ensuring that time coding and billing are accurate in regard to the scope change. • Proactively assesses project safety concerns and ensures PCI Team members are in compliance with any and all client and/or PCI site safety requirements. • Strategically assesses client environments, needs, and requirements to develop and initiate effective solutions and through established solid relationships with clients, delivers successful execution. • Takes client relations initiative and proactively seeks to expand PCI services. A Tech SR may lead projects and serve as "Account Manager" for select clients based on strong client ties and business needs. Skills Required: Expert knowledge and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments. Exceptional Computer Maintenance Management Systems (CMMS) skills. Navigates and utilizes MAS500 Pivot Table and project KPI module to support team leaders and project managers effectively manage LUR & project expenses. Develops and updates PCI Policies and Procedures, understands and interprets Government Regulations and instrumentation/calibration principles and provides training and guidance to Tech I and Tech II resources. Assists clients with development and revision of policies and procedures as necessary. Excellent communication and problem solving skills with clients and coworkers. Thorough electrical panel knowledge and safety practices.

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Excellent negotiation skills with direct identification, development, and implementation of negotiation policies and processes in accordance with PCI objectives. Develops negotiation strategy on complex issues. Significant ability to effectively influence and guide others. Understands the business case and has an appreciation of financial issues and profit and loss implications. Excellent analytical skills with attention to detail while keeping strategic company goals in focus. PCI Trained Mentor. Sought after by technical staff for advice in technical or proposal issues, diplomacy, and ethical practices. Active in PCI onboarding process. Provides both on the job and specialized technical training. Strong applied and working knowledge of FDA; GMP; GLP; compliance and NIST traceability. Expert knowledge of test equipment and capabilities such as tolerance requirements and 4:1 TAR. Actively involved with an external professional organization (ISPE, ASQ, PDA, etc.). External certification preferred (ISA, ASQ, etc.). Experience & Education Required for Senior Calibration Technician: A four-year degree in Life Sciences, Engineering, Electronics, other related technical field or equivalent military training and four plus years of applicable (Metrology, Instrumentation, Calibration) experience or the equivalent combination of education and experience. Quality System/Pharmaceutical experience is required. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website. - See more at: http://jobs.bio.org/jobseeker/job/15600480/Senior%20Calibration%20Technician/__company__/?vnet=0&max=25&t735=120#sthash.VwCHc0QN.dpuf ________________________________________________________________________________ Others since Nov. 1 included: Research Associate, Companion Diagnostics

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Jobs from the Web Associate Director, Analytical Chemistry and Lifecycle Management

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Thousand Oaks, CA, US

11/09/2013

Senior Associate I

Roche

San Francisco, CA, US

11/14/2013

Sr. Manager, Quality & Compliance

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/02/2013

Sr. Medical Writer/Manager Medical Writing Cardiovascular Publications

ExecQuest LLC

Thousand Oaks, CA, US

11/15/2013

Senior QC Associate

Roche

San Francisco, CA, US

11/08/2013

Senior QC Associate

Genentech

South San Francisco, CA, US

11/02/2013

12/8/2013 59

22968 Biochemist (Protein Characterization and Purification,Biacore)

Streffco Consultants, Inc.

Thousand Oaks, CA, US

11/09/2013

100534 QC Assoc II

Roche

San Francisco, CA, US

11/11/2013

100534 QC Assoc II

Genentech

South San Francisco, CA, US

11/11/2013

Associate Project Manager

MedImmune

Hayward, CA, US

11/01/2013

Cell Biochemist – Cellular Assay Development & Screening

Pfizer Inc.

La Jolla, CA, US

11/14/2013

Manager, Quality

Roche

San Francisco, CA, US

11/09/2013

Manager, Quality

Genentech

South San Francisco, CA, US

11/09/2013

22968 Biochemist (Protein Characterization and Purification,Biacore)

Thousand Oaks, CA, US

11/09/2013

22935 Research Associate I/ Analytical Biochemist (HPLC, UV-Vis, HIAC)

Thousand Oaks, CA, US

11/03/2013

Immunology Clinical Laboratory Scientist, CLS - Clinical Laborat - CyberCoders (Anaheim, CA)

Long Beach, CA, US

11/04/2013

Jobs from the Web Micro Biologist

WHPM

Irwindale, CA, US

11/12/2013

Research Associate II, Biology

Onyx Pharmaceuticals, Inc.

South San Francisco, CA, US

10/31/2013

Director/ Senior Director, Translational Medicine

Pharmacyclics

Sunnyvale, CA, US

11/06/2013

Research Associate - Neuroscience

Kelly Services

San Diego, CA, US

11/04/2013

Scientist

Kelly Services

Pleasanton, CA, US

11/04/2013

BIOTECHNOLOGY - MULTIPLE POSITIONS Company Gi...

San Mateo, CA, US

11/04/2013

Clinical Scientist

Kelly Services

South San Francisco, CA, US

11/04/2013

Manager / Senior Manager, Business Development, Genentech Partnering - Genentech (southsanfrancisco,

San Mateo, CA, US

11/05/2013

MEDICAL WRITER - SENIOR, PRINCIPAL OR MANAGER

San Francisco, CA, US

11/12/2013

12/8/2013 60

The Ascent Services Group

Life Sciences Marketing Manager: National Biotechnology and Regional Marketing Leader (Sm&bd)

Deloitte Touche Tohmatsu

Los Angeles, CA, US

11/15/2013

Clinical Research Assistant, Pharmacology / CRA

Sterling Life Sciences

San Francisco, CA, US

11/10/2013

Scientist, BioAnalytical Research & Development

Roche

San Francisco, CA, US

11/01/2013

Scientist, BioAnalytical Research & Development

Genentech

South San Francisco, CA, US

11/01/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (Itgr)

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/14/2013

Scientist

Roche

San Francisco, CA, US

11/05/2013

Scientist

Genentech

South San Francisco, CA, US

11/05/2013

HPLC Chemist - Cosmetic Industry

Kelly Services

North Hollywood, CA, US

11/04/2013

Protein Biochemist

Kelly Services

Thousand Oaks, CA, US

11/06/2013

Scientist II

BioAssay Systems

Hayward, CA, US

11/09/2013

ICP Production Chemist

Kelly Services

Norwalk, CA, US

11/04/2013

Staff Research Assoc II (9612C) #16852

University of California, Berkeley

Berkeley, CA, US

11/14/2013

BIOTECHNOLOGY Company Gilead Sciences, Inc. L...

San Mateo, CA, US

11/01/2013

Senior Research Associate - Biological Technologies

Roche

San Francisco, CA, US

11/01/2013

TC23 - Senior Lab Technician

Kelly Services

Menlo Park, CA, US

11/04/2013

Senior Research Associate - Biological Technologies

Genentech

South San Francisco, CA, US

11/01/2013

Senior Research Associate - Protein Analytical Chemistry

Genentech

South San Francisco, CA, US

11/07/2013

CBG Associate II

Duarte, CA, US

11/04/2013

12/8/2013 61

City of Hope

Lab Associate I, Analytical

R&D Partners

Oakland, CA, US

11/14/2013

Microbiologist II

Randstad

La Jolla, CA, US

11/07/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Roche

San Francisco, CA, US

11/14/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Genentech

South San Francisco, CA, US

11/14/2013

Laboratory Associate I - Analytical

Kelly Services

Emeryville, CA, US

11/14/2013

Scientist - Electrophysiologist

Roche

San Francisco, CA, US

11/07/2013

Viewing 26 - 50 of 90 jobs

Scientist - Electrophysiologist

Genentech

South San Francisco, CA, US

11/15/2013

Sr QC Analyst/QC Associate I/II

Genentech

Vacaville, CA, US

11/05/2013

Associate Director, Analytical Chemistry and Lifecycle Management

Roche

San Francisco, CA, US

11/14/2013

Statistical Geneticist - Parkinsons Disease

Privately Held Biotechnology Company

Mountain View, CA, US

11/12/2013

Biotechnology Term Faculty, Biology

University of San Francisco

San Francisco, CA, US

11/01/2013

Associate Director, Analytical Chemistry and Lifecycle Management

Genentech

South San Francisco, CA, US

11/14/2013

Sr QC Analyst/QC Associate I/II

Roche

Vacaville, CA, US

11/05/2013

Principal Biostatistician, Biostatistics Central Services

Allergan

Santa Barbara, CA, US

11/05/2013

27878 - Research Associate -- Ion Channel Drug Discovery

San Diego, CA, US

11/02/2013

Cell Biologist II

Kelly Services

Thousand Oaks, CA, US

11/04/2013

Sr. Manager/Manager, Quality

Roche

San Francisco, CA, US

11/07/2013

Medical Writer

Sterling Life Sciences

Los Angeles, CA, US

11/10/2013

Lead Senior Scientist, Applications

Fremont, CA, US

11/15/2013

12/8/2013 62

Thermo Fisher Scientific

Sr. Manager/Manager, Quality

Genentech

South San Francisco, CA, US

11/07/2013

22935 Analytical Biochemist I (Protein Charact, HPLC, UV-Vis, HIAC)

Streffco Consultants, Inc.

Thousand Oaks, CA, US

11/09/2013

Quality Control Technician

Kelly Services

Fremont, CA, US

11/04/2013

Senior Associate I

Roche

San Francisco, CA, US

11/14/2013

Sr. Manager, Quality & Compliance

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/02/2013

Scientist II - Diagnostic Product Development

Singulex

Alameda, CA, US

11/07/2013

QC Scientist, Microbiology

Roche

San Francisco, CA, US

11/13/2013

Senior QC Associate

Roche

San Francisco, CA, US

11/08/2013

Director, Product Supply Biotechnology Quality Strategic Analysis & Management Support

Bayer Healthcare

Berkeley, CA, US

11/13/2013

QC Associate II - Biological Technologies

Genentech

South San Francisco, CA, US

11/07/2013

Senior QC Associate

Genentech

South San Francisco, CA, US

11/02/2013

Computational Biologist/Senior Computational Biologist - Cancer Genomics

Genentech

South San Francisco, CA, US

11/05/2013

Engineer I - Late Stage Cell Culture Development

Roche

San Francisco, CA, US

11/02/2013

Associate Director, Quality Control Operations

Bayer

Berkeley, CA, US

11/14/2013

QC Associate II - Analytical Operations

Roche

San Francisco, CA, US

11/07/2013

Engineer I - Late Stage Cell Culture Development

Genentech

South San Francisco, CA, US

11/02/2013

QC Associate II - Analytical Operations

Genentech

South San Francisco, CA, US

11/01/2013

Research Associate I/II - Analytical Operations

Roche

San Francisco, CA, US

11/11/2013

San 11/11/2013

12/8/2013 63

100534 QC Assoc II

Roche

Francisco, CA, US

Research Associate I/II - Analytical Operations

Genentech

South San Francisco, CA, US

11/11/2013

100534 QC Assoc II

Genentech

South San Francisco, CA, US

11/11/2013

Computational Biologist

Roche

San Francisco, CA, US

11/14/2013

Computational Biologist

Genentech

South San Francisco, CA, US

11/15/2013

Biostatistician - 3362

Cor-Tech LLC

Redwood City, CA, US

11/14/2013

Manager, Quality

Roche

San Francisco, CA, US

11/09/2013

Manager, Quality

Genentech

South San Francisco, CA, US

11/09/2013

Senior QC Associate - Genentech (southsanfrancisco, CA)

San Mateo, CA, US

11/08/2013

Statistical Scientist - Nonclinical Biostatistician

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/02/2013

Senior Qc Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer

Roche

San Francisco, CA, US

11/11/2013

Senior Qc Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer

Genentech

South San Francisco, CA, US

Micro Biologist

WHPM

Irwindale, CA, US

11/12/2013

Director/ Senior Director, Translational Medicine

Pharmacyclics

Sunnyvale, CA, US

11/06/2013

Research Associate - Neuroscience

Kelly Services

San Diego, CA, US

11/04/2013

Scientist

Kelly Services

Pleasanton, CA, US

11/04/2013

BIOTECHNOLOGY - MULTIPLE POSITIONS Company Gi...

San Mateo, CA, US

11/04/2013

Clinical Scientist

Kelly Services

South San Francisco, CA, US

11/04/2013

Manager / Senior Manager, Business Development, Genentech Partnering - Genentech (southsanfrancisco,

San Mateo, CA, US

11/05/2013

San Francisco, 11/12/2013

12/8/2013 64

MEDICAL WRITER - SENIOR, PRINCIPAL OR MANAGER

The Ascent Services Group

CA, US

Life Sciences Marketing Manager: National Biotechnology and Regional Marketing Leader (Sm&bd)

Deloitte Touche Tohmatsu

Los Angeles, CA, US

11/15/2013

Clinical Research Assistant, Pharmacology / CRA

Sterling Life Sciences

San Francisco, CA, US

11/10/2013

Scientist, BioAnalytical Research & Development

Roche

San Francisco, CA, US

11/01/2013

Scientist, BioAnalytical Research & Development

Genentech

South San Francisco, CA, US

11/01/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (Itgr)

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/14/2013

Scientist

Roche

San Francisco, CA, US

11/05/2013

Scientist

Genentech

South San Francisco, CA, US

11/05/2013

HPLC Chemist - Cosmetic Industry

Kelly Services

North Hollywood, CA, US

11/4/2013

Protein Biochemist

Kelly Services

Thousand Oaks, CA, US

11/06/2013

Scientist II

BioAssay Systems

Hayward, CA, US

11/09/2013

ICP Production Chemist

Kelly Services

Norwalk, CA, US

11/04/2013

Staff Research Assoc II (9612C) #16852

University of California, Berkeley

Berkeley, CA, US

11/14/2013

Clinical Scientist

Kelly Scientific Resources

South San Francisco, CA, US

10/31/2013

BIOTECHNOLOGY Company Gilead Sciences, Inc. L...

San Mateo, CA, US

11/01/2013

Senior Research Associate - Biological Technologies

Roche

San Francisco, CA, US

11/01/2013

Senior Research Associate - Protein Analytical Chemistry

Roche

San Francisco, CA, US

10/27/2013

TC23 - Senior Lab Technician

Kelly Services

Menlo Park, CA, US

11/04/2013

Senior Research Associate - Biological Technologies

Genentech

South San Francisco, CA, US

11/01/2013

12/8/2013 65

Senior Research Associate - Protein Analytical Chemistry

Genentech

South San Francisco, CA, US

11/07/2013

CBG Associate II

City of Hope

Duarte, CA, US

11/04/2013

Lab Associate I, Analytical

R&D Partners

Oakland, CA, US

11/14/2013

Microbiologist II

Randstad

La Jolla, CA, US

11/07/2013

Senior Scientist, RNAi

Roche

San Francisco, CA, US

10/17/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Roche

San Francisco, CA, US

11/14/2013

Senior Scientist, RNAi

Genentech

South San Francisco, CA, US

10/17/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Genentech

South San Francisco, CA, US

11/14/2013

Laboratory Associate I - Analytical

Kelly Services

Emeryville, CA, US

11/14/2013

Senior Scientist, Immunoassay

Eurofins Lancaster Laboratories

Thousand Oaks, CA, US

10/17/2013

Scientist - Electrophysiologist

Roche

San Francisco, CA, US

11/07/2013

Scientist - Electrophysiologist

Genentech

South San Francisco, CA, US

11/15/2013

Sr QC Analyst/QC Associate I/II

Genentech

Vacaville, CA, US

11/05/2013

Associate Director, Analytical Chemistry and Lifecycle Management

Roche

San Francisco, CA, US

11/14/2013

Statistical Geneticist - Parkinsons Disease

Privately Held Biotechnology Company

Mountain View, CA, US

11/12/2013

Biotechnology Term Faculty, Biology

University of San Francisco

San Francisco, CA, US

11/01/2013

Associate Director, Analytical Chemistry and Lifecycle Management

Genentech

South San Francisco, CA, US

11/14/2013

Sr QC Analyst/QC Associate I/II

Roche

Vacaville, CA, US

11/05/2013

Principal Biostatistician, Biostatistics Central Services

Santa Barbara, CA, 11/05/2013

12/8/2013 66

Allergan

US

27878 - Research Associate -- Ion Channel Drug Discovery

San Diego, CA, US

11/02/2013

Cell Biologist II

Kelly Services

Thousand Oaks, CA, US

11/04/2013

Sr. Manager/Manager, Quality

Roche

San Francisco, CA, US

11/07/2013

Medical Writer

Sterling Life Sciences

Los Angeles, CA, US

11/10/2013

Sr. Manager/Manager, Quality

Genentech

South San Francisco, CA, US

11/07/2013

22935 Analytical Biochemist I (Protein Charact, HPLC, UV-Vis, HIAC)

Streffco Consultants, Inc.

Thousand Oaks, CA, US

11/09/2013

Quality Control Technician

Kelly Services

Fremont, CA, US

11/04/2013

Senior Associate I

Roche

San Francisco, CA, US

11/14/2013

Sr. Manager, Quality & Compliance

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/02/2013

Scientist II - Diagnostic Product Development

Singulex

Alameda, CA, US

11/07/2013

QC Scientist, Microbiology

Roche

San Francisco, CA, US

11/13/2013

Senior QC Associate

Roche

San Francisco, CA, US

11/08/2013

Director, Product Supply Biotechnology Quality Strategic Analysis & Management Support

Bayer Healthcare

Berkeley, CA, US

11/13/2013

QC Associate II - Biological Technologies

Genentech

South San Francisco, CA, US

11/07/2013

Senior QC Associate

Genentech

South San Francisco, CA, US

11/02/2013

Sr SAS Programmer & Sr biostatistician- Bay Area -onsite only

DOCS

San Francisco, CA, US

11/08/2013

Computational Biologist/Senior Computational Biologist - Cancer Genomics

South San Francisco, CA, US

11/05/2013

12/8/2013 67

Genentech

Engineer I - Late Stage Cell Culture Development

Roche

San Francisco, CA, US

11/02/2013

Associate Director, Quality Control Operations

Bayer

Berkeley, CA, US

11/14/2013

QC Associate II - Analytical Operations

Roche

San Francisco, CA, US

11/07/2013

Engineer I - Late Stage Cell Culture Development

Genentech

South San Francisco, CA, US

11/02/2013

QC Associate II - Analytical Operations

Genentech

South San Francisco, CA, US

11/01/2013

Research Associate I/II - Analytical Operations

Roche

San Francisco, CA, US

11/11/2013

100534 QC Assoc II

Roche

San Francisco, CA, US

11/11/2013

Research Associate I/II - Analytical Operations

Genentech

South San Francisco, CA, US

11/11/2013

100534 QC Assoc II

Genentech

South San Francisco, CA, US

11/11/2013

Computational Biologist

Roche

San Francisco, CA, US

11/14/2013

Computational Biologist

Genentech

South San Francisco, CA, US

11/15/2013

Biostatistician - 3362

Cor-Tech LLC

Redwood City, CA, US

11/14/2013

Manager, Quality

Roche

San Francisco, CA, US

11/09/2013

Manager, Quality

Genentech

South San Francisco, CA, US

11/09/2013

Senior QC Associate - Genentech (southsanfrancisco, CA)

San Mateo, CA, US

11/08/2013

Statistical Scientist - Nonclinical Biostatistician

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/02/2013

Senior Qc Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer

Roche

San Francisco, CA, US

11/11/2013

Senior Qc Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer

Genentech

South San Francisco, CA, US

11/11/2013

12/8/2013 68

Senior Manager/Associate Director, Business Development, Genentech Partnering

Genentech

South San Francisco, CA, US

11/15/2013

Bioinformatics Programmer

AltheaDx

San Diego, CA, US

11/07/2013

Programmer LIMS

AltheaDx

San Diego, CA, US

11/07/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Genentech

South San Francisco, CA, US

11/14/2013

Senior Research Associate, Pharmdx R&D 1

Agilent Technologies

Carpinteria, CA, US

11/07/2013

Research Associate, Companion Diagnostics

Agilent Technologies

Carpinteria, CA, US

11/07/2013

Clinical Scientist

Kelly Services

South San Francisco, CA, US

11/04/2013

Manager / Senior Manager, Business Development, Genentech Partnering - Genentech (southsanfrancisco,

San Mateo, CA, US

11/05/2013

R&D Scientist

Agilent

La Jolla, CA, US

11/02/2013

Senior Scientist - R&D Toxicology

Thermo Fisher Scientific

Fremont, CA, US

11/15/2013

QC Microbiologist

Novartis Diagnostics

Vacaville, CA, US

11/15/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (Itgr)

F. Hoffmann-La Roche Ltd

San Francisco, CA, US

11/14/2013

Research Associate, Companion Diagnostics

Agilent

Carpinteria, CA, US

11/08/2013

Senior Research Associate, pharmDx R&D 1

Agilent

Carpinteria, CA, US

11/08/2013

Staff Scientist, Assay Development

Lloyd Staffing

CA, US

11/05/2013

Clinical Research Associate/Biostatistics

CosignMed

Fremont, CA, US

11/12/2013

Junior Developer Intern

AltheaDx

San Diego, CA, US

11/07/2013

San Francisco, 11/14/2013

12/8/2013 69

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Roche

CA, US

Laboratory Associate I - Analytical

Kelly Services

Emeryville, CA, US

11/14/2013

Director, Marketing - Virology

Hologic

San Diego, CA, US

11/13/2013

SR TECHNICAL SUP SPEC

Abbott

Carlsbad, CA, US

11/04/2013

Sr SAS Programmer & Sr biostatistician- Bay Area -onsite only

DOCS

San Francisco, CA, US

11/08/2013

QC Manager, Methods Validation

Novartis Pharmaceuticals

Emeryville, CA, US

11/05/2013

MOLECULAR TECHNOLOGIST

IDEA Recruit

San Diego, CA, US

10/30/2013

Clinical Project Manager

Abbott

Carlsbad, CA, US

10/31/2013

Calibration Technician III - Covina, CA

Danaher

Covina, CA, US

10/17/2013

Calibration Technician

Cepheid

Sunnyvale, CA, US

10/26/2013

Calibration Technician

Cepheid - US

Sunnyvale, CA, US

10/20/2013

Immunology Clinical Laboratory Scientist, CLS - Clinical Laborat - CyberCoders (Anaheim, CA)

Long Beach, CA, US

11/04/2013

Assoc, Lab I

Quest Diagnostics

West Hills, CA, US

11/12/2013

Scientist, Test Development II

Quest Diagnostics

Valencia, CA, US

11/01/2013

Microbiologist Sr

Siemens Healthcare Diagnostics Inc.

West Sacramento, CA, US

11/06/2013

Scientist, Assay Integration

GenMark Diagnostics

Carlsbad, CA, US

11/07/2013

Chemistry Technician with Diagnostics Experience

Lab Support, a division of On Assignment

San Jose, CA, US

11/02/2013

Software Engineer

GenMark Diagnostics, Inc.

Carlsbad, CA, US

11/06/2013

12/8/2013 70

Biostatistician

GE Healthcare

Aliso Viejo, CA, US

11/06/2013

Senior Biostatistician

Real Staffing

San Francisco, CA, US

11/14/2013

Lead Senior Scientist, Applications

Thermo Fisher Scientific

Fremont, CA, US

11/15/2013

Technical Writer

Kelly Services

Emeryville, CA, US

11/04/2013

Regulatory Medical Writer (home based)

OnPoint Consulting

Los Angeles, CA, US

10/31/2013

Clinical Research Assistant, Pharmacology / CRA

Sterling Life Sciences

San Francisco, CA, US

11/10/2013

Technical Writer

Kelly Engineering Resources

Emeryville, CA, US

10/31/2013

Scientist

Adecco

Pleasanton, CA, US

11/15/2013

Biomedical Technician/Device Educator

Los Angeles, CA, US

11/07/2013

Biomedical Software Engineer

MAKO Surgical Corp.

Silicon Valley, CA, US

11/06/2013

Clinical Research Associate/Biostatistics

CosignMed

Fremont, CA, US

11/12/2013

Assoc Director, Medical Writer

BioSoteria

Emeryville, CA, US

10/27/2013

Senior Product Transfer Scientist

Cepheid - US

Sunnyvale, CA, US

11/12/2013

Biomedical Engineer -R&D

Ultimate Staffing Services

Irvine, CA, US

11/08/2013

Director, Marketing - Virology

Hologic

San Diego, CA, US

11/13/2013

Biomedical Engineer

Curexo Technologies

Fremont, CA, US

11/12/2013

Medical Writer - Transcatheter Heart Valve

Edwards Lifesciences

Irvine, CA, US

11/02/2013

Medical Writer

Sterling Life Sciences

Los Angeles, CA, US

11/10/2013

Quality Control Technician

Kelly Services

Fremont, CA, US

11/04/2013

12/8/2013 71

Sr. biostatistician- SoCal/remote

DOCS

Diamond Bar, CA, US

11/08/2013

Sr. Medical Writer/Manager Medical Writing Cardiovascular Publications

ExecQuest LLC

Thousand Oaks, CA, US

11/15/2013

Sr.Biostatistician

DOCS

Pleasanton, CA, US

11/05/2013

Sr SAS Programmer & Sr biostatistician- Bay Area -onsite only

DOCS

San Francisco, CA, US

11/08/2013

Medical Writer - Transcatheter Heart Valve - Edwards Lifesciences (Irvine, CA)

Long Beach, CA, US

11/05/2013

Lead Biostatistician

DOCS

Pleasanton, CA, US

Jobs from the Web Senior Manager/Associate Director, Business Development, Genentech Partnering

Genentech

South San Francisco, CA, US

11/15/2013

Micro Biologist

WHPM

Irwindale, CA, US

11/12/2013

Scientist, BioAnalytical Research & Development

Genentech

South San Francisco, CA, US

11/11/2013

Scientist

Genentech

South San Francisco, CA, US

11/05/2013

Senior Research Associate - Biological Technologies

Genentech

South San Francisco, CA, US

11/11/2013

Senior Research Associate - Protein Analytical Chemistry

Genentech

South San Francisco, CA, US

11/07/2013

Field Application Scientist

Qiagen

Redwood City, CA, US

11/11/2013

Associate Scientist/Scientist- Immunology Tissue Growth and Repair (ITGR)

Genentech

South San Francisco, CA, US

11/14/2013

Scientist - Electrophysiologist

Genentech

South San Francisco, CA, US

11/15/2013

Postdoctoral Researcher - Bioinformatics

Genentech

South San Francisco, CA, US

11/15/2013

Sr QC Analyst/QC Associate I/II

Genentech

Vacaville, CA, US

11/05/2013

Associate Director, Analytical Chemistry and Lifecycle Management

Genentech

South San Francisco, CA, US

11/14/2013

Sunnyvale, 11/06/2013

12/8/2013 72

Director/ Senior Director, Translational Medicine

Pharmacyclics

CA, US

QC Sr Scientist - Commercial

Genentech

South San Francisco, CA, US

11/15/2013

Research Associate - Neuroscience

Kelly Services

San Diego, CA, US

11/04/2013

Molecular Biologist

Hired by Matrix, Inc.

San Diego, CA, US

11/09/2013

Technical Writer

Kelly Services

Emeryville, CA, US

11/04/2013

Scientist

Kelly Services

Pleasanton, CA, US

11/04/2013

Scientist

Johnson & Johnson

San Diego, CA, US

11/11/2013

Scientist, BioAnalytical Research & Development

Experteer

South San Francisco, CA, US

11/04/2013

Scientist

Lancaster Laboratories

San Francisco, CA, US

11/11/2013

Clinical Scientist

Kelly Services

South San Francisco, CA, US

11/04/2013

Senior QC Associate

Genentech

South San Francisco, CA, US

11/02/2013

Manager / Senior Manager, Business Development, Genentech Partnering - Genentech (southsanfrancisco,

San Mateo, CA, US

11/05/2013

MEDICAL WRITER - SENIOR, PRINCIPAL OR MANAGER

The Ascent Services Group

San Francisco, CA, US

11/12/2013

Senior Research Scientist Structural Biologist

Eli Lilly

San Diego, CA, US

11/06/2013

Computational Biologist/Senior Computational Biologist - Cancer Genomics

Genentech

South San Francisco, CA, US

11/05/2013

Clinical Research Assistant, Pharmacology / CRA

Sterling Life Sciences

San Francisco, CA, US

11/10/2013

Engineer I - Late Stage Cell Culture Development

Genentech

South San Francisco, CA, US

11/06/2013

QC Associate II - Analytical Operations

Genentech

South San Francisco, CA, US

11/06/2013

Scientist - Bio Analytical Mass Spectrometry Job

Merck

Palo Alto, CA, US

11/11/2013

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Research Associate I/II - Analytical Operations

Genentech

South San Francisco, CA, US

11/11/2013

Scientist

Eurofins Lancaster Laboratories

South San Francisco, CA, US

11/11/2013

Scientist, BioAnalytical Research & Development

Roche

San Francisco, CA, US

11/01/2013

Scientist

Adecco

Pleasanton, CA, US

11/15/2013

QC Microbiologist

Novartis Diagnostics

Vacaville, CA, US

11/15/2013

Research Associate

Yoh

South San Francisco, CA, US

11/06/2013

Associate Scientist

AlphaProTemps, A.P.R., Inc. (MBE/SDB/8a)

Carlsbad, CA, US

11/12/2013

Staff Development Scientist

Bayer

Berkeley, CA, US

11/14/2013

HPLC Chemist - Cosmetic Industry

Kelly Services

North Hollywood, CA, US

11/04/2013

Computational Biologist

Genentech

South San Francisco, CA, US

11/15/2013

Medical Writer- regulatory

San Diego, CA, US

11/10/2013

Contract Administrator – Biotechnology

Hire Counsel

San Francisco, CA, US

10/16/2013

Protein Biochemist

Kelly Services

Thousand Oaks, CA, US

11/06/2013

Sr. Systems Verification Specialist

Becton Dickinson

San Jose, CA, US

11/02/2013

Manager, Quality

Genentech

South San Francisco, CA, US

11/04/2013

Biologist and Pharmaceutical Scientists, Chinese

1000 Person Plan

Los Angeles, CA, US

11/07/2013

ICP Production Chemist

Kelly Services

Norwalk, CA, US

11/04/2013

Medical Writer

F. Hoffmann-La Roche Ltd

Pleasanton, CA, US

11/04/2013

Menlo Park, 11/04/2013

12/8/2013 74

TC23 - Senior Lab Technician

Kelly Services

CA, US

Biologist and Pharmaceutical Scientists, Chinese Speaking

China

San Jose, CA, US

11/04/2013

Senior QC Pharmaceutical Specialist-Pharmaceutical Specialist Method Transfer

Genentech

South San Francisco, CA, US

11/14/2013

Senior Research Scientist Structural Biologist

Lilly

San Diego, CA, US

11/02/2013

Manager/ Sr. Manager, Quality & Compliance

Experteer

South San Francisco, CA, US

11/04/2013

Biostatistician II

Genentech

South San Francisco, CA, US

11/15/2013

Senior Product Transfer Scientist

Cepheid - US

Sunnyvale, CA, US

11/12/2013

Senior Scientist - Biologics Discovery Job

Merck

Palo Alto, CA, US

11/11/2013

QC Technician

Response Genetics

Los Angeles, CA, US

11/05/2013

QC Pharmaceutical Specialist II-Contract Labs/ExQC

Genentech

South San Francisco, CA, US

11/14/2013

Protein Biochemist

Hired by Matrix, Inc.

San Diego, CA, US

11/09/2013

Laboratory Associate I - Analytical

Kelly Services

Emeryville, CA, US

11/14/2013

Sr. Biostatistician

HPPS

Foster City, CA, US

11/14/2013

Associate Development Scientist

Bayer

Berkeley, CA, US

11/08/2013

Associate Director, Analytical Chemistry and Lifecycle Management

Roche

San Francisco, CA, US

11/14/2013

Associate Director - High Throughput Screening

Experteer

San Diego, CA, US

11/12/2013

Sr. Product Manager, Mass Spec Sample Preparation

Agilent

Santa Clara, CA, US

11/09/2013

Sr QC Analyst/QC Associate I/II

Roche

Vacaville, CA, US

11/05/2013

Santa 11/05/2013

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Principal Biostatistician, Biostatistics Central Services

Allergan

Barbara, CA, US

27878 - Research Associate -- Ion Channel Drug Discovery

San Diego, CA, US

11/02/2013

Cell Biologist II

Kelly Services

Thousand Oaks, CA, US

11/04/2013

Medical Writer - Transcatheter Heart Valve

Edwards Lifesciences

Irvine, CA, US

11/02/2013

Sr. Manager/Manager, Quality

Roche

San Francisco, CA, US

11/07/2013

QC Pharmaceutical Specialist/Sr QC Pharmaceutical Specialist

Roche

San Francisco, CA, US

10/24/2013

Medical Writer

Sterling Life Sciences

Los Angeles, CA, US

11/10/2013

Sr. Manager/Manager, Quality

Genentech

South San Francisco, CA, US

11/07/2013

22935 Analytical Biochemist I (Protein Charact, HPLC, UV-Vis, HIAC)

Streffco Consultants, Inc.

Thousand Oaks, CA, US

11/09/2013

Senior Scientist / Chemistry

Forsight Labs LLC

Menlo Park, CA, US

************************************************************************************ https://jobs.smartbrief.com/action/listing?listingid=7E63722C-8B87-447B-90D5-AEB82E119367&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06 Job Summary Date Posted: 10/16/13 Location: Irvine , CA Director, Global Communications Edwards Lifesciences Job Description Highly-visible position reporting to Senior Director, Global Communications. This is a great opportunity to play a key role and use your strategic, writing and media relations skills to support Global Communications' efforts at Edwards Lifesciences. Position Summary:

Support the planning and execution of external communications activities that will positively position the company, business units and products, as well as neutralize and/or mitigate risks.

Work closely with Edwards' business units as well as internal business partners, to generate awareness and understanding for products and initiatives.

Key Responsibilities: Develop a deep understanding of Edwards Lifesciences' business and its products

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Develop strategic communications plans to best position business units, products, initiatives and the company

Conduct research that may complement communications plans and strategies Fact-find and relationship-build with product and marketing managers within business units and

other internal sources to identify opportunities and relevant information Develop materials and messages, including but not limited to, press releases, presentations,

speeches/talking points and Web site copy Conduct research on, track and proactively identify media opportunities Pitch and develop strong relationships with media and respond quickly and accurately to inquiries,

as needed Support communications and business unit functions at medical congresses (domestic and

international) Work with external agencies to coordinate communications activities and projects Manage special projects, including but not limited to, patient and physician video testimonials and

the company annual report Collaborate on the production of media monitoring summaries and quarterly media reports Regularly collaborate with legal, regulatory and compliance colleagues to obtain guidance and

necessary approvals on projects, written materials and other communications Collaborate with internal communications team on activities Travel internationally and domestically 10-15% Relocation possible for ideal profile

A minimum of 7-10 years of related public relations agency or corporate communications experience with a successful track record in strategic planning, written materials, media relations and reputation building is required. Experience working with medical technology, healthcare or biotech businesses/products is required. Global experience is a plus. A Bachelor's degree in Communications, Journalism, Public Relations or a related field is required. Required Skills:

Keen understanding of media relations with emphasis on story/message development and successful reporter interaction

Excellence in the lifecycle of written communications, including research, drafting, editing and securing approvals. These written materials may include press releases or background pieces, articles, interview briefings or reports, as well as research and benchmarking

Ability to demonstrate accountability for results and sound business judgment/decision-making Proactive and energetic personality Active listener, open to new ideas and perspectives Ability to provide guidance and advice on media strategy for both proactive and reactive

opportunities Solid presentation and speaking skills Attention to detail, especially proofreading Ability to build productive relationships and work cooperatively with internal and external business

partners across a variety of functions and geographies in order to deliver on commitments Experience collaborating with multiple corporate departments and outside consultants to manage

diverse projects Experience with access to and responsibility for confidential information and projects Ability to lead project teams and also serve as a valuable contributor to others' project teams Ability to anticipate and plan for future events and understand the impact of an action in one area

of the company on another Ability to work in a fast-paced environment, be hands-on in project management and execution

and simultaneously manage multiple deadlines Keys to Success:

Self-starter mentality, takes guidance well but also develops proactive ideas and solutions Passion to learn Diligence and relentless pursuit of goals Flexibility Commitment to excellence

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************************************************************************************ https://jobs.smartbrief.com/action/listing?listingid=EF793E25-1538-4CFE-9B40-F9E4D097663E&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06 Employment Counsel Edwards Lifesciences Job Description This senior attorney will have primary responsibility for legal support in connection with labor and employment issues including employment agreements and corporate employment policies, enforcement of non-compete and confidentiality and trade secret provisions, wage and hour requirements, and job classification issues. This attorney will also partner closely with the Human Resources organization and business leaders providing advice and counsel in connection with potential disciplinary actions, terminations, or other employment actions. This attorney will also have primary responsibility for strategic management of employment-related claims (including investigation of labor-related charges and drafting position statements, engaging and managing outside counsel, and negotiating the resolution of disputed claims). In addition to these primary responsibilities, this attorney may be asked to provide legal support in the area of privacy, and may be asked to provide support for litigation matters. This attorney will be expected to work on special assignments as needed, develop a close working relationship with senior managers, lead working teams containing members with diverse backgrounds and perspectives to achieve strategic goals of the business, and facilitate communications with, and build consensus among, colleagues and management. This position involves routine interaction with management at various levels within the operating businesses. Some travel between the company’s offices in Irvine, California and other facilities should be expected. An outstanding academic record and a law degree from a nationally recognized university is required. In addition, the candidate must have seven to ten years’ experience, with a minimum of three years’ in-house experience strongly preferred, with emphasis in employment and labor counseling and employment claim management. Privacy experience is strongly preferred; litigation experience is a plus. Required Skills:

Collaborate effectively with employees at all levels of the corporation, analyze problems and present solutions, alternatives and risk analyses to management, gain the confidence and respect of management, and drive projects to completion

Admission to practice law in the State of California is required Strong writing, editing and presentation skills are a must Mature, independent judgment and excellent communication and interpersonal skills Ability to think strategically and to formulate creative and practical legal business solutions is

critical ************************************************************************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=ADEF0557-AAE4-4876-87A4-F4EF1E661334&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06 Job Summary Date Posted: 10/24/13 Location: 92614, CA Director, Information Security Management

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Edwards Lifesciences Job Description The Director Information Security Management is responsible for establishing and maintaining a corporate-wide security management program to ensure that information assets, technology and intellectual property are adequately protected. This role operates as the chief information security officer who directly manages a team of IT security professionals and collaborates with the corporation’s physical security team to promote a comprehensive security program. This position is responsible for identifying, evaluating and reporting on security risks in a manner that meets compliance and regulatory requirements, and aligns with and supports the risk posture of the enterprise. The role requires a visionary leader with sound knowledge of business management and a working knowledge of information security technologies. This role will proactively work with business units and shared services organizations to implement practices that meet defined policies and standards for information security. He or she will also oversee a variety of IT-related risk management activities. The ideal candidate is a thought leader, a consensus builder, and an integrator of people and processes. A key element of the Director Information Security Management role is working with executive management to determine acceptable levels of risk for the organization. While the Director Information Security Management is the leader of the security program, he or she must also be able to coordinate disparate drivers, constraints and personalities, while maintaining objectivity and a strong understanding that security is just one of the business's activities. It cannot be undertaken at the expense of the enterprise's ability to deliver on its goals and objectives. The Director Information Security Management must be highly knowledgeable about the business environment and ensure that information systems are maintained in a fully functional, secure mode. Ultimately, the Director Information Security Management is a business leader, and should have a track record of competency in the field of information security or risk management, with eight to ten years of relevant experience, including four years in a significant leadership role. Responsibilities:

Develop, implement and monitor a strategic, comprehensive enterprise security IT risk management program in collaboration with existing IT and physical security teams, to ensure the security, integrity, confidentiality and availability of information that is owned, controlled or processed by the organization

Develop, maintain and publish up-to-date security policies, standards and guidelines. Oversee the approval, training, and dissemination of security policies and practices for all employees, contractors and approved system users

Create and manage information security and risk management awareness training programs Create, communicate and implement a risk-based process for vendor risk management, including

the assessment and treatment for risks that may result from partners, consultants and other service providers

Create a framework for roles and responsibilities with regard to information ownership, classification, accountability and protection

Provide regular reporting on the current status of the information security program to enterprise risk teams, senior business leaders and the board of directors as part of a strategic enterprise risk management program

Manage security incidents and events to protect corporate information assets, technology and intellectual property, regulated data and the company's reputation. Monitor the external threat environment for emerging threats, and advise relevant stakeholders on the appropriate courses of action

A minimum of eight to ten years of experience in a combination of risk management, information security and IT jobs with at least four in a senior leadership role. Employment history must demonstrate increasing levels of responsibility. A Bachelors degree is required. A Master’s degree in information technology, business administration or a related field is preferred. Required Skills:

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Professional security management certification, such as a Certified Information Systems Security Professional (CISSP), Certified Information Security Manager (CISM), Certified Information Systems Auditor (CISA) or other similar credentials, is desired

Leadership experience developing global policies and strategies in collaboration with existing IT and physical security teams to protect, human, physical and information technology assets and intellectual property around the world

A strong understanding and knowledge of information security standards and laws (e.g., ISO 27001/27002, NIST, FFIEC, etc), and commonly used concepts, practices and procedures within the information security and privacy field

Knowledge of common information security management frameworks, such as ISO/IEC 27001, ITIL, COBIT and ones from NIST

Knowledge of privacy regulations and appropriate safeguards Excellent written and verbal communication skills, interpersonal and collaborative skills, and the

ability to communicate security and risk-related concepts to technical and nontechnical audiences Poise and ability to act calmly and competently in high-pressure, high-stress situations Experience in mobile device management and access controls; Experience in data protection

processes and technologies, cyber threat management, incident response, vulnerability testing **************************************************************************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=9384C782-979E-425A-AD90-96F14CC47DF8&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06 Job Summary Date Posted: 11/11/13 Location: Sunnyvale, CA Salary Range: Excellent Years Experience: 10 plus Job Contact Phone: 818-493-3002 Manager or Principal Regulatory Affairs Nanostim Job Description Manager or Principal level Regulatory Affairs Professional for Sunnyvale It’s an exciting time for St. Jude Medical and Nanostim! We are seeking a qualified Principal level Regulatory Affairs professional to join our team! This person will be based in the Nanostim offices located in Sunnyvale.

Some of the responsibilities include: Acting independently to identify and resolve problems, is responsible for regulatory submissions

work for an assigned project effort. Prepares reviews and coordinates project submissions for regulatory approvals.

Develops the regulatory strategy for project team(s). Applies advanced regulatory expertise to the evaluation and solution of submission problems. Initiates the planning, organizing, performing, coordinating and/or directing of regulatory work,

and may contribute to the performance evaluations of other department personnel. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most

effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.

Requirements/Education: A Bachelor’s Degree in Science, Engineering, a related field. Typically a minimum of eight plus years of progressively more responsible medical device regulatory/submission experience. Applies an extensive technical expertise and/or a thorough specialized knowledge of cardiac rhythm management technology, such as pacemakers, as well as the clinical trial process. Work requires a

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comprehensive knowledge of FDA and related domestic and international regulatory document submission requirements, and the necessity of working within those constraints. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks. A qualified record of implementing new processes to existing regulatory and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering regulatory information which adds value to managements decision making process. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Desired Requirements: An advanced credential in a relevant discipline/concentration. Specialized experience and/or relevant advanced coursework related to regulatory submission applications, programs, and processes. Academic or in-house courses in project management, leadership, training, Total Quality Management (TQM), and various technical applications as noted above. EU submissions experience a must Entrepreneurial spirit appreciated! ** If you are interested, please email or call me directly. Teresa Gertsman @ 818.493.3002 or tgertsman@sjm.com Check out this amazing place! https://www.linkedin.com/company/nanostim-inc *********************************************************************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=756ADC68-CF18-4DD3-AC3F-1E41FC4448C8&briefid=77F8DA5B-9982-431B-9E20-444163A3CF79 Date Posted: 11/12/13 Location: San Jose, CA Years Experience: 6+ Legal Counsel Stryker Corporation Job Description Under minimal supervision, responsible for handling a variety of complex assigned legal projects and helps to drive Stryker’s compliance efforts for two divisions: Stryker Endoscopy and its Communications business unit. Proactively identifies and manages legal and compliance issues governed by Stryker policies, US Federal and State law and International law. • Serves as the “point person” for all legal issues related to the Stryker Endoscopy and its Communications business unit, providing legal advice in a highly regulated environment. • Drafts, reviews, negotiates and advises on various types of contracts including but not limited to Sales, Services, Supply Distribution, Consulting, Clinical Study, Non-Disclosure, Employment and other commercial agreements. • Conducts legal analysis and provides counsel on laws, rules, regulations, and Stryker policies related to Stryker’s interactions with healthcare professionals, both in the US and outside the US, including but not limited to the US anti-kickback law, the FCPA and other local anti-corruption laws, and helping to ensure that Stryker’s compliance program in this area is robust and effective at minimizing risk in this area. • Manages or assists in managing litigation and legal claims matters involving Stryker Endoscopy and its Communications business unit, other Stryker business units, Stryker Legal team and outside counsel. • Reviews marketing, promotional and scientific activities and materials for compliance with Stryker policies and applicable laws. • Drafts, implements, addresses and trains on violations of legal and compliance policies designed to help ensure Stryker complies with applicable laws, rules and regulations and manages its legal and compliance affairs effectively and efficiently. • Partners closely with the Compliance Department on compliance initiatives, policies and programs and ensures Stryker Endoscopy and its Communications business unitare in compliance with applicable laws,

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rules, regulations and policies. Assists the Compliance team in managing a robust compliance program to address key compliance risks. • Partners closely with Legal Department personnel supporting countries outside the US in connection with Stryker Endoscopy and its Communications business unit on legal and compliance matters. • Provides analysis and counsel on various other relevant legal issues as they arise, including but not limited to medical device regulations, intellectual property, employment, mergers and acquisitions, data privacy, competition law, anti-corruption / anti-bribery laws, liability avoidance and sales and marketing related issues. Role Qualifications • Excellent organization skills; ability to manage multiple projects and conflicting demands • Ability to work well independently and in a team; ability to build relationships with key clients, co-workers and business partners • Possesses strong analytical and problem-solving skills • Complies with all Stryker’s policies and procedures • Demonstrated interpersonal, communication and presentation skills. Ability to articulate / translate complex professional knowledge to various customers • Ability to communicate at all levels of the organization • University degree with strong academic record. • J.D. / Law Degree with strong academic record. Experience • Minimum of 6 years of related experience in a law firm or corporate legal department for an international firm. • Significant experience dealing with high end and complex legal issues with significant financial impact is required. • Experience in compliance, commercial law and contracts. Valued, but not required skills and experience • Pharmaceutical, medical device, food or other highly regulated industry experience preferred. • Previous experience in regulatory matters, litigation, intellectual property or employment law valued. INTERNAL REQUISITION #24229

Jobs That Crossed My Desk Through Nov. 3, 2013 ************************************************************************************ http://www.indeed.com/viewjob?jk=8430f76d0686da45&from=api&q=(%22medical+device%22)+$80,000%2B&atk=188qkhf5v19r11eb&sclk=1&sjdu=RV4mlg7GBO_mpDHZdbN8oMeq3vA2r4soi_OZKiDbqN3gGpLvI0XiOeqHOyHMRZ8wVQ0GaiwYV17EB9stwXZCWqvQ2Pqjdq4CXNQwVi_E1wI0Nm_SJd9fWSAsMFSKnXIb International Regulatory Affairs Manager - Santa Maria, CA Real Staffing - Santa Maria, CA Objective Under general direction, will prepare regulatory submission documents for FDA and International filings and provide regulatory assessment of manufacturing changes and marketing promotional materials.

Secure and maintain establishment annual licenses, registrations and listings. Drive International Product Registration projects to completion. Negotiate and interact with international regulatory authorities during the development and review process to ensure submission approval.

Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.

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Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products.

Prepare regulatory submissions including 510(k) submissions; assist in the preparation of IDE and PMA.

Provide review of general internal Quality System compliance to regulations. Ensure compliance with product post-marketing approval requirements. Submit Product Complaints System reporting including FDA MDR's, EU Vigilance, and Canadian

Medical Device reporting. Provide cross functional or new product development teams with guidance to meet regulatory

requirements and to support product filings. Assist QA in maintenance of CE Technical Files. Maintain Declarations of Conformity. Review proposed document changes to determine level of impact and consequent submission

requirements (including Notified Body Notices Of Change). Provide regulatory input for and appropriate follow-up to inspections and audits, and accompany inspection team(s) as required.

Assist in the development of departmental policy and regulatory strategy. Develop and maintain productive and effective relationships with regulatory authority

reviewers, peers, and superiors. Demonstrate a high standard of work ethics and professionalism to regulatory authority

reviewers, peers, and superiors at all times. Represent the company in a positive and supportive manner at all times.

Required Skills Knowledge of FDA QSR's and U.S. Food, Drug, and Cosmetic Act as amended. Knowledge of ISO 13485, Medical Device Directives and Health Canada (CMDR) requirements, Knowledge of medical device manufacturing or a related field. Skill in demonstrating a professional phone manner. Ability to work independently, take initiative and make decisions within department/company

guidelines. Required Experience Bachelor's degree (B.A./B.S.) from four-year college or university in a scientific field; and three to five years related experience; or equivalent combination of education and experience. Previous medical device regulatory experience desirable. To find out more about Real please visit www.realstaffing.com Real Staffing - 15 days ago - save job - block http://www.indeed.com/viewjob?jk=83a125e1f67b4d47&from=api&q=(%22medical+device%22)+$80,000%2B&atk=188qkhf5v19r11eb&sclk=1&sjdu=RV4mlg7GBO_mpDHZdbN8oMeq3vA2r4soi_OZKiDbqN2Qzswd0F25_-uv0yOCA3KdVQ0GaiwYV17EB9stwXZCWqvQ2Pqjdq4CXNQwVi_E1wI0Nm_SJd9fWSAsMFSKnXIb Regulatory Affairs Manager - Bay Area, CA - Class II Start-Up Real Staffing - San Jose, CA

Currently seeking a Senior Regulatory Affairs Specialist to join the organization's team at a very exciting time. Seeking an experienced candidate who has a passion for our mission and an unwavering commitment to operational excellence. Reporting to the Senior VP, Regulatory Affairs, this hands-on role has responsibility for drafting the 510(k) Submission for the device and supporting that Submission through concurrence at FDA. In addition, this role will support both IDE and 510(k) Submission work for next generation devices as well as support select approvals in OUS markets. The successful candidate will:

Draft key regulatory submissions and ensure the successful clearance and/or approval of same.

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Work with a talented multi-disciplined engineering group to document, validate, and verify product designs and design changes and confirm compliance with Design Control regulations.

Review test protocols and test reports to confirm updated designs, and corresponding testing, conform to relevant requirements.

The desired candidate will have: 5-7+ years of successful experience with increasingly complex regulatory submissions. Direct experience with drafting 510(k) Submissions that were successfully navigated

through the approval process at FDA. Direct experience drafting original IDE Submissions and relevant Supplements, Annual

reports, and other Amendments. Experience with CE Mark process including authoring Clinical Experience Summaries, as

required by MDD. A balanced approach to regulatory judgments. Clear and independent thinking. A personality that is focused, driven, ambitious and seeks out innovative approaches to

challenges. A person who thrives in a fast paced, intense culture. A person with high integrity and

character, who is tough minded, fair and principled. Exceptional communication skills and whose daily actions are culture building. The ability to interface effectively with all levels and functions within the organization. Strongly preferred, but not mandatory, experience with capital equipment devices that

include hardware, firmware and software. The preferred candidate will have an undergraduate degree in a field relevant to a regulatory position in the medical device industry. To find out more about Real please visit www.realstaffing.com ************************************************************************* http://www.indeed.com/viewjob?jk=3c77afd790966e55&from=api&q=(%22medical+device%22)+$80,000%2B&atk=188ql89ei19vh37a&sclk=1&sjdu=3TEPkymJaenhOmJQRNbwmS_kee17kRXpdrjRlrAQTIMyLWL2ewyO8vUEEFPRN_iz56_eqA83O5NETxl1wxIH8jBjdcCdC2ZPG42gvm1kazTgV8BQ2QB7WovvCFAdv4rlsOOjdw9XON1NY5uz9HAWBbtOxbkpwBJ73NxDmKoriQuXY_mNX_mqAmhpCdUGgnUWSYy5YmY8nAKyyJZL9EV4yg Materials Manager San Jose, CA NEEDED FOR A CUSTOM PLASTIC INJECTION MOLDING MEDICAL DEVICE FIRM IN NORTHERN CALIFORNIA A profitable and growing client of many years has asked my team to located a talented and high achieving Materials Manager for their facility located in Northern California. The client is a privately held, custom plastic processing firm that services the global Healthcare market. A single source supplier with experience in vertically integrated solutions, utilizing expertise in thermoplastics and elastomers to develop processing solutions for medical components and devices. *************************************************************************** http://www.indeed.com/viewjob?jk=be11473ff214c109&from=api&q=(%22medical+device%22)+$80,000%2B&atk=188ql89ei19vh37a&sclk=1&sjdu=3TEPkymJaenhOmJQRNbwmS_kee17kRXpdrjRlrAQTIOSJKdDB0RijNnsIXF598CSnMkQxj2mHkIOthIvPHkuvyFNNIvFxFdLPKHO_BTftWjgV8BQ2QB7WovvCFAdv4rlsOOjdw9XON1NY5uz9HAWBbtOxbkpwBJ73NxDmKoriQuXY_mNX_mqAmhpCdUGgnUWSYy5YmY8nAKyyJZL9EV4yg Senior R&D Engineer - Neurovascular Job Fremont, CA Join one of the fastest growing Divisions of Stryker and work with cutting edge technology that saves patients lives. DESCRIPTION: Independently conducts development work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects. Viewed

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as an expert in one or more in-house technologies. Essential Duties & Responsibilities

Drives complex or novel assignment requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and/or scientific method to broaden Stryker NV Intellectual Property in key strategic areas.

Successfully completes engineering work in one or more of the following: technology development, product design and development, test of materials, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.

Provides guidance to product and technology teams. Assesses the feasibility and soundness of alternative engineering processes, products, or

equipment. Coordinates, manages, and documents project goals and progress and recommends

appropriate revisions. Interfaces with Physicians/Cath Lab personnel to identify needs and to obtain feedback

on concepts and performance of new devices and to translate customer needs into product concepts.

Demonstrates knowledge of internal product and/or technology development processes through coaching and delivery of high quality, high impact deliverables.

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

QUALIFICATIONS: BS in Engineering 5 - 8 years experience in the medical device industry preferably with

catheters/stents/coils ************************************************************************* Apply on company website Vice President, Clinical Development Masimo - Irvine, CA 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 VICE PRESIDENT, CLINICAL DEVELOPMENT Responsible for the development of engineering and post-market clinical research to meet company objectives, advocacy of clinical evidence through presentations, publications, and speaking bureau events, and management of the company’s key opinion leader meetings. Manages Clinical Research Associate (CRA) and Clinical Advocacy personnel toward department objectives. Interfaces with customers, key opinion leaders, Engineering, Regulatory, Marketing, and Executive Management. Acts as resource to internal and external customers on clinical issues. Duties and Responsibilities: 1. Strategy development a. Create a strategic map of relevant clinical study evidence by parameter / product b. Work closely with marketing and exec management to identify clinical study opportunities and

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priorities 2. Study development a. Initiate and co-develop clinical study concepts with internal and external customers b. Identify project sites, define budgets, and time required to complete a clinical study concept c. Solicit and evaluate investigator-initiated research proposals d. Develop/approve/edit protocols, case report forms, database specifications, and statistical plan e. Perform a risk analysis of protocols with investigator and internal input f. Recruit investigators / sites g. Negotiate support level with investigators h. Ensure appropriate regulatory controls (site and patient) in place for studies i. Manage clinical trial agreements and internal and external review process 3. Monitoring a. Conduct study start-up activities, train site personnel, conduct interim monitoring visits and study close-out visits. b. Monitor data collection to ensure timely completion of all studies c. Manage auditing mechanism to ensure data quality and protocol compliance d. Track and review study documents such as case report forms, source documents and adverse event forms in order to ensure completeness and accuracy e. Review regulatory documentation for completeness and accuracy during study initiation and maintains such documentation throughout the study f. Assist site personnel with data changes as needed to ensure clarity and accuracy of the data g. Ensure timely and accurate transfer of data into database format h. Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH Guidelines, HIPPA, trial registration, and all other applicable regulatory guidelines i. Prepares monitoring reports based on each site visit j. Managing equipment and sensor inventory and return upon study completion 4. Analysis and reporting a. Manage internal data analysis and required outside statistical analysis to meet both protocol-identified and additional investigator statistical analysis objectives b. Produce study results reports for internal and investigator review c. Conduct data review calls get gain alignment with investigators toward publication 5. Publication planning a. Work with investigators to proactively identify presentation and publication targets b. Assist investigators toward dissemination of study results in scientific meetings and publications 6. Clinical education � Develop and manage comprehensive clinical education program for all content and geographies � Propose and manage educational content, speakers, administrative, and promotion of company sponsored CME and CEU programs � Recruit and manage national speakers bureau list and active program participation to drive education initiatives � Deliver education programs directly at local and national venues7. Evidence library � Manage master citations library � Provide updated abstracts of presented and published data for marketing and sales use in collateral and web8. Key opinion leader meetings a. Work collaboratively with marketing and Medical Affairs to identify KOL meetings including Scientific Advisory Boards, Global Advisory Board, and select private meetings b. Manage meeting agendas and dissemination of information to attendees 9. Personnel management a. Hire, train, and perform annual employee evaluations b. Manage data collection and site visit activities c. Assign and manage additional project objectives as necessary 10. Budget management a. Propose annual budge to meet company research objectives within budget growth guidelines b. Monitor and manages all aspects of the clinical research budget c. Monitor and communicate individual study and overall budget status at regular intervals

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11. Functional management a. Develop necessary departmental procedures and evaluations b. Complete required reports within established timeframes c. Provide proactive problem solving and timely follow-up customer issues d. Stay professionally current and follow all procedures related to this job which can affect the quality of products or services provided to our customers 12. Education, Experience, Skills, Physical Requirements a. Education i. Bachelor’s Degree (B.A. or B.S.) in engineering, science, or medical field ii. Masters Degree (MBA, MSN, MS) or Doctorate (MD, PhD) is highly desirable b. Experience i. Ten or more years of medical device, biotech, or pharma clinical research management experience c. Skills i. Current knowledge and understanding of the hospital and health care environment ii. Excellent communication and presentation skills iii. Positive, service-oriented attitude iv. Excellent project management skills v. Excellent writing skills vi. Advanced ability to use all Microsoft Office Applications d. Physical i. Based out of corporate office in Irvine – person must live in Southern California ii. Up to 25% overnight travel may be required iii. Flexible work hours and weekend work may be required iv. Valid California driver’s license, passport, and ability to drive to research sites We are proud to offer a highly competitive compensation plan with an excellent benefits package including 3 weeks vacation, stock options, 401k match, medical, dental, vision plans and much more!

http://www.indeed.com/viewjob?jk=f03617b5f5720343&from=api&q=(%22medical+device%22)+$80,000%2B&atk=188qkpssc19u149v&sclk=1&sjdu=5Mmq1YSd2kR8hxoC94gIMsKRGHqEKcE12BbG_5-Xk0S6KS2p0ujD7CmXwL_fOBLN19JENlLT1aaf2Dz2ZoPcuAwVLWtwvWoL7uELEKkgVWiQL3yVIg5-pqohPXKsdaWYnECFQh4WBHnk9GDIHjL9PGpKfIg7uiXQu_m4VhA6TCQ Compliance Manager San Jose, CA The ComplianceManager is responsible for assisting inmanaging the development, implementation, and improvement of an effective quality system designed to meet appropriate WW Business, Corporate, Government, and International Standards for efficacy, safety, and quality. Assures programs are consistent in complying at a minimum with FDA 21 CFR Part 820 Quality System Regulation, FDA 21 CFR Part 803 Medical Device Reporting, FDA 21 CFR Part 806 Corrections and Removals, ISO 13485 QMS Medical Devices, ISO 9000 QMS and international regulations and standards for IVD and Medical Device products in both clinical and research applications as well as custom products. Works on complex problems where ... http://www.indeed.com/cmp/Cytori-Therapeutics/jobs/Medical-Affair-Associate-981051e22c480445 Medical Affairs Associate Cytori Therapeutics - San Diego, CA Medical Affairs Associate Department: Clinical

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Reports To: Chief Medical Officer Location: San Diego, California ABOUT US Cytori Therapeutics, Inc. is dedicated to developing and delivering innovative cell-based therapies to improve the quality and length of life. We are a global, public company engaged in the development and commercialization of stem and regenerative cell therapies for the treatment of cardiovascular disease, reconstructive surgery and many other serious, chronic, and life threatening conditions. SUMMARY To assist the Chief Medical Officer in providing the execution of corporate strategies relative to compliance, reimbursement, market access, medical information formation and dissemination, as well as act as the medical information liaison between the organization’s external stakeholders and customers. The person will have primary responsibility overseeing the Investigator Initiated Study program and publication planning. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Primary responsibility overseeing the Investigator Initiated Study program Participate in developing medical education programs. Publication planning Participate in the development and execution of market access and reimbursement strategy for the organization. Assist in development and execution of organizational compliance programs and documents. Assist in acting as a medical education liaison to patients and external customers. Assist in development of long-term Policy and Advocacy activities. Compile and disseminate relevant medical and scientific literature to internal and external stakeholders. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Excellent communication skills, both oral and written – must have the demonstrated ability to explain complex concepts in simple, clear ways. Must be able to function effectively in a fast-moving team environment. Excellent organizational and time management skills EDUCATION and/or EXPERIENCE Pharm D, RN, or PhD within the life sciences preferred. Candidates with Bachelor’s degree within life sciences will be considered. Medical device or pharmaceutical industry experience preferred. SYSTEMS TECHNOLOGY SKILLS Microsoft Word, Excel, Outlook, Power-point, Internet applications. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, bend, and sit. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals. EQUAL EMPLOYMENT OPPORTUNITY Cytori Therapeutics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. http://www.indeed.com/cmp/hansen-medical/jobs/Senior-Control-Senior-System-Engineer-d167110a0a33deb9

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Senior Controls/Senior Systems Engineer Hansen Medical - Mountain View, CA Summary: Our Senior Engineer will contribute at a senior level to the development of Hansen’s complex tele-robotic systems. The ideal candidate will have demonstrated the ability to participate at both the architectural level and at the detail level as a hands-on contributor. The candidate must have the ability to make sound technical decisions, prioritize project deadlines, and follow up with critical items. Essential Functions:

Responsibilities will include the development and maintenance of controls, visualization, and/or robotics algorithms.

Duties will span both technology development (investigation of new technologies and prototyping) and product development (systems analysis, design, documentation, and testing activities).

Additional responsibilities include systems analysis, design, and testing activities at the system level as well as at the component level

Technical Knowledge: Systems engineers require knowledge from controls, visualization, and robotics. A well-qualified candidate will exhibit strength in one area and some experience in other areas.

Controls o Hands-on experience with integrating electro-mechanical system components, including sensors, actuators, signal conditioning and data acquisition electronics o Experience in developing electro-mechanical products; preferably robotic applications o Experience in designing a hard real-time controller for mechanical systems

Robotics: o Experience with robotics modeling including 3D transformations, forward and inverse kinematics, and Jacobians o Experience in dynamic modeling, analysis or synthesis of physical systems o Experience with haptic rendering algorithms

Visualization: o Experience in OpenGL with advanced rendering technologies such as scene graphs, transparency, or GPU programming o Experience in 3D user interface programming within WPF and .NET or other touch-screen enabled operating systems o Experience with computer vision and image processing algorithms o Experience with physical simulation techniques Requirements:

Requires all of one area of technical knowledge above or a strong mix of multiple disciplines Solid software engineering and programming background, with experience in team application

development required Strong Software development experience in C/C++/C#/Java and Object Oriented design Hands on experience implementing and debugging complex real-time systems Medical device experience a strong plus Experience with systems modeling and data analysis tools required; experience with Matlab

and Simulink a strong plus Must have strong analytical and problem solving skills, as well as a background in both the

technology development process and the product development process Strong communication and people skills Able to plan activities and act as technical lead to explore new technology Comfortable working with and seeking optimum solutions with team members in adjacent

disciplines of mechanical, electrical and software engineering MS in Mechanical, Electrical Engineering, or Computer Science (or related field) with 3 or more

years of relevant experience, PhD preferred Hansen Medical, Inc. is an Equal Opportunity Employer. ************************************************************************** Apply on company website

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Vice President, Operations Masimo - Irvine, CA 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 The Vice President, Operations is responsible for managing all operations related to manufacturing, materials, facilities, distribution, engineering and maintenance to ensure smooth, continuous, cost effective and controlled manufacture of products in support of the business' forecasts and inventory goals. Duties & Responsibilities:

Top level strategic planning of the Company’s Operations Activities; Develop and maintain Operations Objectives and strategies to meet or exceed Goals; Create and maintain world-class manufacturing for ultimate quality, and low cost; Develop and execute COGS reduction plan to meet or exceed Company’s margin targets; Maintain manufacturing capacities to always stay ahead of the demand; Create and maintain manufacturing disaster recovery plan; Develop and execute supply chain management strategies to ensure on-time delivery of parts

with highest quality and lowest cost; Manage inventory levels to meet Company’s inventory turns target while achieving on-time

shipment targets; Manage multiple projects to successfully transition products to manufacturing; Develop and execute plans to meet or exceed manufacturing yield targets; Interface with senior level managers, peers and direct reports, to maintain mutual

understanding of product design needs, regulatory, and production requirements; Understand FDA Regulations, ISO-13485, ISO-9001, European Medical Device Directives

(MDD), Canadian Medical Device Regulations (CMDR), and Japanese Regulations (J-GMP); Direct, plan, delegate and manage department budget and staff including: Hire, promote, demote, reclassify or terminate employees Write and conduct performance appraisals and disciplinary actions plans Make salary decisions (pay increases or new hire offers) Create training and employee development plans Handle all departmental employee relations issues Performs special projects as requested.

Minimum & Preferred Qualifications and Experience: Minimum Qualifications:

Twelve or more years of high level Operations management; Excellent strategic planning and organization skills; Excellent communication skills, both verbal and written; A mature thinking and acting executive with good common sense and judgment, and a broad

business perspective with outstanding administrative capabilities to build, motivate, and manage the Company through rapid sales growth;

Highly intelligent, perceptive individual who possesses excellent conceptual, analytical, and problem-solving ability;

Must be a self-starter; a “hands-on” individual who enjoys a challenge and is dedicated to getting the job done;

The ability to effectively interface with other Executives in the Company and work

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collaboratively to achieve Company goals; Comfortable in high visibility situations and exhibits strong self-confidence; Must be PC literate, have excellent organizational and communication skills;

Preferred Qualifications:

Not Applicable Education: Bachelor’s degree, preferably in engineering, is required. 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. We are proud to offer if eligible a highly competitive compensation plan with an excellent benefits package including 3 weeks vacation, stock options, 401k match, medical, dental, vision plans and much more! Masimo is proud to be an EOE, M/F/D/V, and we value and are committed to Diversity at every level. ***NO AGENCIES PLEASE*** Thank you! Masimo - 22 days ago - save job - block *********************************************************************** https://jobs.smartbrief.com/action/listing?listingid=ADEF0557-AAE4-4876-87A4- F4EF1E661334&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8 Director, Information Security Management Edwards Lifesciences Job Description The Director Information Security Management is responsible for establishing and maintaining a corporate-wide security management program to ensure that information assets, technology and intellectual property are adequately protected. This role operates as the chief information security officer who directly manages a team of IT security professionals and collaborates with the corporation’s physical security team to promote a comprehensive security program. This position is responsible for identifying, evaluating and reporting on security risks in a manner that meets compliance and regulatory requirements, and aligns with and supports the risk posture of the enterprise. The role requires a visionary leader with sound knowledge of business management and a working knowledge of information security technologies. This role will proactively work with business units and shared services organizations to implement practices that meet defined policies and standards for information security. He or she will also oversee a variety of IT-related risk management activities. The ideal candidate is a thought leader, a consensus builder, and an integrator of people and processes. A key element of the Director Information Security Management role is working with executive management to determine acceptable levels of risk for the organization. While the Director Information Security Management is the leader of the security program, he or she must also be able to coordinate disparate drivers, constraints and personalities, while maintaining objectivity and a strong understanding that security is just one of the business's activities. It cannot be undertaken at the expense of the enterprise's ability to deliver on its goals and objectives.

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The Director Information Security Management must be highly knowledgeable about the business environment and ensure that information systems are maintained in a fully functional, secure mode. Ultimately, the Director Information Security Management is a business leader, and should have a track record of competency in the field of information security or risk management, with eight to ten years of relevant experience, including four years in a significant leadership role. Responsibilities:

Develop, implement and monitor a strategic, comprehensive enterprise security IT risk management program in collaboration with existing IT and physical security teams, to ensure the security, integrity, confidentiality and availability of information that is owned, controlled or processed by the organization

Develop, maintain and publish up-to-date security policies, standards and guidelines. Oversee the approval, training, and dissemination of security policies and practices for all employees, contractors and approved system users

Create and manage information security and risk management awareness training programs Create, communicate and implement a risk-based process for vendor risk management, including

the assessment and treatment for risks that may result from partners, consultants and other service providers

Create a framework for roles and responsibilities with regard to information ownership, classification, accountability and protection

Provide regular reporting on the current status of the information security program to enterprise risk teams, senior business leaders and the board of directors as part of a strategic enterprise risk management program

Manage security incidents and events to protect corporate information assets, technology and intellectual property, regulated data and the company's reputation. Monitor the external threat environment for emerging threats, and advise relevant stakeholders on the appropriate courses of action

A minimum of eight to ten years of experience in a combination of risk management, information security and IT jobs with at least four in a senior leadership role. Employment history must demonstrate increasing levels of responsibility. A Bachelors degree is required. A Master’s degree in information technology, business administration or a related field is preferred. Required Skills:

Professional security management certification, such as a Certified Information Systems Security Professional (CISSP), Certified Information Security Manager (CISM), Certified Information Systems Auditor (CISA) or other similar credentials, is desired

Leadership experience developing global policies and strategies in collaboration with existing IT and physical security teams to protect, human, physical and information technology assets and intellectual property around the world

A strong understanding and knowledge of information security standards and laws (e.g., ISO 27001/27002, NIST, FFIEC, etc), and commonly used concepts, practices and procedures within the information security and privacy field

Knowledge of common information security management frameworks, such as ISO/IEC 27001, ITIL, COBIT and ones from NIST

Knowledge of privacy regulations and appropriate safeguards Excellent written and verbal communication skills, interpersonal and collaborative skills, and the

ability to communicate security and risk-related concepts to technical and nontechnical audiences Poise and ability to act calmly and competently in high-pressure, high-stress situations Experience in mobile device management and access controls; Experience in data protection

processes and technologies, cyber threat management, incident response, vulnerability testing ******************************************************************** *************************************************************************

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

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See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer. http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ******************************************************************** 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/$FILE/Beyond_borders_2012.pdf See Beyond Borders Matters of Evidence 2013 biotechnology report at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes

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are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections:

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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 experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________

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“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. ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” 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 There’s a new biotech job site on the BIO website entitled Bio Jobs: The Talent Hub for Biotech at http://jobs.bio.org. You can search for open positions via various parameters. Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com

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There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities.

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The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************