5/18/2014 1 Jobs That Crossed My Desk Through May 18, 2014 Complimentary Service of Audreysnetwork.com May 18, 2014 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. You can search jobs by function, state and industry at http://jobs.bio.org/c/search_results.cfm?vnet=0&t735=120&t730=&max=25&t732=& site%5Fid=15768&t731=&str=26 Location Posted STAFF AUTOMATION ENGINEER Job Johnson & Johnson Vacaville , Californi a, United States 05/17/2 014 Principal Scientist - Protein Expression Job Merck Palo Alto, Californi a, United States 05/17/2 014 QA SCIENTIST I ANALYTICAL LAB Job Johnson & Johnson Los Angeles, Californi a, United States 05/17/2 014 GLOBAL HEAD OF ENABLING TECHNOLOGIES Job Johnson & Johnson San Diego, Californi a, United States 05/17/2 014
Transcript
5/18/2014 1
Jobs That Crossed My Desk Through May 18, 2014 Complimentary Service of Audreysnetwork.com
May 18, 2014
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.
You can search jobs by function, state and industry at http://jobs.bio.org/c/search_results.cfm?vnet=0&t735=120&t730=&max=25&t732=&
Regional Clinical Specialist – San Francisco Bay Area field based position Licensed RN 5+ years of relevant medical device industry experience as a Clinical Specialist Experience in acute care setting, complex, multiple contact points, project-oriented implementation
with products that require significant training and on-going support Ability to travel, up to 30% Excellent interpersonal and communication skills; ability to adapt to changing work priorities Experienced in clinical training and education
Sr. Regulatory Affairs Manager /Director (timing may be Q3) BS/BA in relevant field, advanced degree is desirable 8+ years experience in Regulatory Affairs (US & OUS) within the medical device industry Class II device experience is required Extensive 510K filings experience is required Excellent written and oral communication skills; technical writing capabilities are a must _____________________________________________________________________
SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT Regional Sales Manager – San Francisco Bay Area base preferred (West Coast)
BA/BS degree, MBA preferred 10+ years of relevant sales and/or sales management experience in the medical device industry
(acute care setting, complex, multiple call point, project oriented-implementation sale) Experience selling into hospitals (acute care) is required
Patient monitoring device experience desired (not a must) Ability to travel 30% - 50% Excellent verbal and written communication skills
Field Technical Service Manager - San Francisco Bay Area based role BS degree (Computer Science, Engineering) 4+ years of relevant customer facing technical field support experience(acute care setting,
complex, project oriented IT implementation) 4-6+ years of system administration experience Familiarity with hospital data systems, including experience in: configuring and supporting Citrix
Xenapp systems, various VDI solutions, and hospital nurse call and other nursing communication systems, configuring HL7 interfaces.
Excellent customer relations, listening and organizational skills Ability to handle internal IT needs for small company Experience with wireless networks in the hospital environment desired (not required)
Marketing & Business Development Mgr/Dir– OIL & ENERGY industry experience – field based role BS in Mechanical, Electrical or Industrial Engineering
10-15+ years of experience in business development & sales and have sold to large & small companies as well as developing key accounts
Sales & Business Development experience in the Oil & Gas industry (experience in other relevant industries would include Aerospace, Manufacturing, Semiconductor, Gas, Automotive, Pipeline and
Power Plant) Ability to travel (US, Canada & Europe) German language skills would be a plus
__ MANUFACTURING, OPERATIONS & R&D ENGINEERING Production Manager – Industrial X-Ray industry – position based in Connecticut
Strong knowledge & experience in lean manufacturing and 5S
Proven management skills, leading others in operations/manufacturing environments Experience in relevant industry (Aerospace, Manufacturing, Semiconductor, Gas, Automotive,
Pipeline and Power Plant) SAP experience BSME, BSEE or relevant degree
Proficient in SolidWorks 15+ years of industry experience, at least 3+ years experience directly managing a staff
********************************************************************************** To become a WIB member, learn more about the MAPs program or enroll in the SF-chapter MAPs
program, click here: http://www.womeninbio.org/mentoring/ WIB SF Chapter creates a Mentors, Advisors and Peers (MAPs) Program WIB SF chapter recently rolled out its Mentors, Advisors and Peers (MAPs) program. This unique initiative
is made available free of cost to its members living in the Bay Area. Six to ten women meet informally to discuss topics of common professional interest (peer-to-peer mentoring) or individuals are matched with a mentor who can best help in one's development (one-on-one mentoring). Three peer groups are already underway in San Francisco, the North Peninsula and South Peninsula, while other groups are planned for
the South Bay, East Bay and North Bay. Some of the discussion topics include career planning, transitioning careers, work/family balance, managing a team or department, leading or running a company, entrepreneurship, raising capital and promoting women at work. This is a great opportunity to meet, connect and learn from women with experience in various aspects of
the Biotech world! ******************************************************************************* https://www.linkedin.com/jobs2/view/13951917?trk=eml-b2_group_digest-groupjobpost-job-16 Clinical Trial/Study Managers and/or Study Start Up Specialists
Advanced Clinical - San Francisco, CA Posted 1 day ago Job description Please contact me regarding more information on the following positions in San Francisco, CA!
Long term contracts San Francisco, no remote work- must be on-site Relocation candidates welcomed We have Clinical Study/Trial Manager and Study Start-Up Specialist positions! Desired Skills and Experience Please contact me for more details Advanced Clinical is an integrated biotech and pharmaceutical services provider offering talent management, strategic resourcing, and complete Clinical Research Outsourcing (CRO). We offer the insight and resources our clients need to overcome clinical research challenges and achieve success. Be Advanced ... Advanced Solutions for a Better Clinical Experience. ************************************************************************* Apply on company website
Clinical Trial Associate R&D Partners - San Francisco Bay Area Posted 3 days ago Job description
Our client is a leading biotech company with multiple products in the market and a promising therapeutic pipeline. The Clinical Trial Associate is responsible for providing logistical support for Phase I and Phase II clinical
studies. Develop, maintain and manage appropriate study documentation Initiate, maintain and reconcile Trial Master File Set up and maintain tracking systems and tools and report study metrics to support the clinical
study Manage and track study-specific payments Desired Skills and Experience
Bachelor’s degree or equivalent undergraduate degree required (scientific or healthcare discipline preferred)
2+ years industry experience in equivalent role Working knowledge of international regulatory and ICH GCP guidelines A Life Science Based Staffing Firm - Pairing Talent with Opportunity in the Areas of Scientific, Clinical Research and Engineering.
We specialize in consulting, direct hire & outsourcing solutions. R&D Partners offers over 200 years of collective life science staffing experience in the biotech, pharmaceutical and medical device industries. Our recruiting professionals are dedicated to understanding a candidate’s aptitude and career goals while
partnering with companies that offer a stable and growing pipeline ********************************************************************************** Apply on company website
Clinical Outsourcing Associate - San Francisco, CA Medivation - San Francisco, CA Posted 2 days ago Job description
Clinical Outsourcing Associate Medivation, Inc. (NASDAQ: MDVN – www.medivation.com) is a publicly traded biopharmaceutical company located in San Francisco. We are currently seeking a qualified, highly motivated, experienced
individual for the position of Clinical Outsourcing Associate. Support key activities related to the outsourcing of clinical services with a particular emphasis on clinical vendor outsourcing and contract management of clinical service providers across multiple studies and
programs within Clinical Development. Facilitate compliance with key processes, manage costs, optimize processes, and ensure timely study execution in support of corporate and department goals. Able to work collaboratively with cross-functional groups with minimal supervision to ensure the most optimal solutions are achieved in alignment with department strategies. Essential duties and responsibilities include but are not limited to the following:
Facilitate key outsourcing processes (with minimal supervision) including vendor evaluation, Request for Proposals, and vendor selection for designated clinical programs, clinical studies, or vendor types.
Review, analyze, and negotiate scopes of work, exhibits, budgets, payment schedules to be included as contract attachments.
Coordinate contract terms/conditions review, approval, and signature process with external parties and internal stakeholders and act as central point of contact through negotiations, approvals, and execution.
Partner with clinical teams in the generation of specifications for work to be outsourced; determine candidate vendors based on capabilities, capacity, strategic fit, expertise, quality, performance and price.
Contribute to RFP content and process, compile and prioritize selection criteria/requirements, and
facilitate decision process to ensure objectivity and adherence to selection criteria. Follow mechanisms for management of vendor relationships and performance to ensure compliance
against contracted services for outsourced work and escalate issues as appropriate. Provide detailed oversight of scope management; ensure that any contractual changes in scope are
communicated, agreed, documented, and transparently proportional to actual activity or incurred cost. Maintain current awareness of clinical outsourcing industry trends and contribute to process
improvement and new process development.
Requirements:
2-3 years of experience in clinical research environment and understanding of clinical terminology, process, and timeline drivers.
Procurement expertise (preferably in clinical research or service procurement). Contract management and negotiation experience preferred (budget and terms and conditions).
Proven ability to build and maintain effective internal and external relationships. Sound background of financial/controlling issues. Must have strong analytical, negotiating and business communication skills. Must be self-motivating and be able to:, follow directions precisely, prioritize and manage a large
volume of work, handle a moderate amount of pressure, and show attention to detail. Proficient with word processing, spreadsheet and database software. Experience and confidence working with multiple functional areas and facilitating communication
across multiple levels of internal/external teams.
Excellent interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.
PC literacy required; MSOffice skills (Outlook, Word, Excel).
Education:
Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceutical) or business degree or equivalent. ******************************************************************************** To apply, please send your resume to [email protected]
5/18/2014 10
Senior Systems Engineer GenapSys - Redwood City, CA At GenapSys we are working to change the world of healthcare and diagnostics. Our team brings together an incredibly diverse and multidisciplinary set of backgrounds and skills – from electrical and mechanical engineers, to physicists, chemists, microfluidic engineers, molecular biologists, bioinformaticians, mathematicians and more. Together we will advance scientific and medical knowledge and improve human health through cheaper, faster, and more accurate DNA sequencing technologies. We’re looking for talented and passionate team players to join our fast-paced startup company. The ideal candidate will be dedicated, hard-working and have a passion for building something different that can impact medical research and patient care. If you want to help change the current paradigm of DNA sequencing send your resume and cover letter to [email protected] . Please include a short description that tells us how you stand out as an ideal contributor to the GenapSys vision and goals
Responsibilities Design ownership of DNA sequencing instrument that includes fluidics, pneumatics, electronic,
and thermal components, including all design files and production transfer documentation Design of fixtures, assembly, and test for pre-production instruments for hand off to contract
manufacturers Defining test procedures, control plans and process sheets to transfer to production. Inspection, assembly and test of prototype parts, devices and machines. Work with cross functional teams to validate and optimize instruments for assay effectiveness
and reproducibility Design and build next generation version of the instrument after successful handoff to
production Supervise system design team (4 – 6 people) and prototyping engineering laboratory
Requirements Bachelor’s or Master’s degree in mechanical engineering or relevant technical degree with 10+
years experience designing and building systems that integrate fluidics, mechanics, heat transfer, and electronics.
Advance knowledge of manufacturing and prototyping processes
Experience with Design for Assembly (DFA), Design for Manufacture (DFM) and Failure Mode and Effect Analysis (FMEA) preferred
Experience applying tolerance and DOE methods to systems made up of dissimilar technologies like fluidics, mechanics, and electronics.
Experience in the design and manufacture of instruments that have been approved as a class II or class III FDA medical device
Innovative, driven, results/data-oriented and methodical, with record of achievement commensurate with previous experience
Experience managing and coordinating complex projects (Gantt & Pert Charts) About GenapSys At GenapSys, we are developing a DNA-sequencing technology that will revolutionize the world of
healthcare. Our system will enable fast, accurate, and ultra-low cost genetic tests in order to better understand (and ultimately treat) genetic diseases such as Cancer, Parkinson’s, Diabetes, and Alzheimers, just to name a few. GenapSys was founded by Dr. Hesaam Esfandyarpour, and incubated over 6 years (2004-2010) at Stanford University. The company was incorporated in early 2010 and is
funded by leading firms in both venture and institutional capital. We have built an incredible team of scientists, engineers, and business professionals – join our team and be part of the adventure!
Jobs That Crossed My Desk Through May 11, 2014 ******************************************************************************
See descriptions for four positions at Zyomyx,Inc on company website at http://www.zyomyx.com/about/careers/
5/18/2014 11
Process Engineer
Systems Engineer
Research Associate-0430
Research Associate-0405
Others not posted as yet appear below: If you are up to the excitement and challenge of continuing the success of Zyomyx, and in joining a phenomenal team that is on a driven mission to significantly and positively impact lives globally, submit
your resume with title of “QE” in email Subject line to: [email protected] ************************************************************************************ INTERIM CONTROLLER ®
Zyomyx, Inc. is a privately held diagnostics company – a developer, manufacturer and marketer of innovative point-of-care diagnostic products. Our first product, the revolutionary MyT4 POC CD4 diagnostic test for HIV/AIDs in developing countries, will contribute to saving millions of lives around the world. Zyomyx’s current focus is on this key core product. We also know that incredible future potential
opportunities exist from our other various core technology platforms to bring complex lab diagnostics into POC, a growing and burgeoning worldwide market. As a result, the Company will launch products targeting high income countries as well over the coming years. Summary: In this critical position reporting to the CFO, you will oversee the Company’s accounting functions, as well
as cost accounting functions. You will be responsible for the general accounting activities of the company in accordance with GAAP, including month-end-close, financial reporting and ad hoc projects as needed. You will manage accounts payable, cash management/disbursement, payroll, and stock maintenance. In addition, you will develop, implement and maintain Company and Accounting policies and procedures.
Position Responsibilities Include:
and in accordance with GAAP
edger
o Invoicing/billing
lanning to drafting the audited financial statements
o Inventory Control
o Revenue Recognition
o Overhead Absorption Rate Analysis
o Cycle Counts, Physical Inventories dules for various filings, audits, and tax returns, including local, state and corporate tax,
sales and use tax, property tax, and franchise tax
nd Excel -15 years accounting and finance experience
-task and work in a fast-paced environment under tight deadlines If you are up to the excitement and challenge of continuing the success of Zyomyx, and in joining a phenomenal team that is on a driven mission to significantly and positively impact lives globally, submit your resume with title of “IC” in email Subject line to: [email protected] _______________________________________________________________________________________________
QUALITY ENGINEER ® Zyomyx, Inc. is a privately held diagnostics company – a developer, manufacturer and marketer of innovative point-of-care diagnostic products. Our first product, the revolutionary MyT4 POC CD4 diagnostic
test for HIV/AIDs in developing countries, will contribute to saving millions of lives around the world. Zyomyx’s current focus is on this key core product. We also know that incredible future potential opportunities exist from our other various core technology platforms to bring complex lab diagnostics into POC, a growing and burgeoning worldwide market. As a result, the Company will launch products
targeting high income countries as well over the coming years. We seek a highly motivated Quality Engineer to expand its Quality Team. The successful applicant will be responsible for managing supplier quality and in-coming acceptance activities. She/he will actively participate in the knowledge transfer from Product Development to Manufacturing, as well as support
equipment and process validation to insure compliance to quality requirements. Some activities will conducted in a BSL2 laboratory area and may involve the handling of human biological samples. Other activities are conducted in a cleanroom setting. Principal Duties and Responsibilities
monitoring/trending/non-conformances in partnership with Manufacturing Engineering. Chair materials and vendor review boards.
-coming quality control activities and provide hands-on support as necessary; develop and implement sampling plans, acceptance and release test methods, specifications and criteria.
-process, and release testing and associated documentation.
and QC data.
quality requirements and design control procedures (documentation, test methods validation, V&V activities).
equipment validation activities to ensure compliance to internal quality requirements.
regulatory submissions.
Requirements
(Biochemistry, Chemistry, Materials Science, or Medical Devices).
-10 years of experience in quality, product development or process development within an industrial environment, in a FDA and/or ISO 13485 regulated medical device setting, with knowledge of regulations. Experience with in vitro diagnostic products preferred.
Date Posted: 5/1/14 Location: San Diego, CA Years Experience:
3-5 Regulatory Affairs Specialist Biotech Center of Expertise~San Diego, CA BASF Job Description
JOB DESCRIPTION: • Are you a highly motivated self-starter looking to join a dynamic regulatory affairs team? • Do you have the ability to comprehend and interpret material and issues of a scientific or technical
nature? • Are you prepared to put your advanced written and oral communication skills to use in the biotech arena?
If this sounds like you, then we want to get to know you… We are BASF, the world’s leading chemical company and the leader in sustainable chemical solutions. BASF Corporation has over 17,000 employees in North America with sales of over $19.4 billion in 2013.
Our portfolio ranges from chemicals, plastics, performance products and crop protection to oil and gas. As a reliable partner, BASF creates chemistry to help its customers in virtually all industries to be more successful. Further information on BASF is available on the internet at http://www.basf.com or in the Social Media Newsroom at newsroom.basf.com.
Now here is where you come in… BASF, “The Chemical Company” is seeking exceptional candidates for a Regulatory Affairs Specialist to assist in the development of regulatory submissions for BASF products in the U.S. and other geographies.
The successful candidate will have opportunities to work on multiple pipeline products and interact with multiple departments to ensure compliance with applicable U.S. and international regulations by preparing product submission documentation, and providing guidance to project teams as it relates to the application of regulatory requirements. This role will also support the regulatory function with respect to
database management, maintaining regulatory files and assisting on assigned projects, as needed. The Regulatory Affairs Specialist is a highly motivated self-starter responsible for: • Preparing draft and final versions of regulatory submissions to U.S. and International regulatory
agencies using knowledge or experience in biotech regulations for substances used in food and industrial processes. • Participating on product development teams as assigned. • Providing support to Process Development, Manufacturing, QA/QC, and Business Development using
knowledge of biotech regulations and food cGMP’s. • Summarizing technical and safety information in final study reports for regulatory submissions. • Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions.
• Assisting in coordinating and maintaining a document control system for pertinent regulatory documents. Where you’ll work: The selected individual will join R&D, manufacturing, marketing, business development and sales persons at the San Diego CA Center of Biotech Expertise. This location develops and commercializes high-performance enzymes for use in industrial processes. Does this sound like the right job for you? Yes? Then we would like to hear from you…Please click “apply” to get the process started. QUALIFICATIONS: • BASF recognizes institutions of Higher Education which are accredited by the Council for Higher Education Accreditation or equivalent
• Bachelor’s degree in Biology or related field, e.g. Molecular Biology, Microbiology, etc. ; MS degree preferred • Minimum of 3 years of experience in Regulatory Affairs, preferably with prior experience in the biotech industry
• Must be able to comprehend, interpret and convey scientific information • Knowledge of FDA food regulations, food cGMP’s, EPA TSCA regulations, and NIH Guidelines for research involving rDNA molecules is highly desirable • Must represent the regulatory function with professionalism and integrity
• Strong computer skills • Advanced written and verbal communication skills
199b99dc80c0&utm_source=brief Job Summary Date Posted: 5/1/14
Location: San Diego, CA Years Experience: 5-7 Sr. Regulatory Specialist, Biotech Center of Expertise~ San Diego, CA
BASF Job Description We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected
veteran status, or any other characteristic protected by law. JOB DESCRIPTION:
• Are you an ambitious team player looking to join a growing team and help fulfill BASF’s commitment to ensure compliance with applicable US and international regulatory requirements? • Have you effectively interacted with regulatory agencies? • Are you able to read, interpret and convey scientific information?
If this sounds like you, then we want to get to know you… We are BASF, the world’s leading chemical company and the leader in sustainable chemical solutions.
BASF Corporation has over 17,000 employees in North America with sales of over $19.4 billion in 2013. Our portfolio ranges from chemicals, plastics, performance products and crop protection to oil and gas. As a reliable partner, BASF creates chemistry to help its customers in virtually all industries to be more successful. Further information on BASF is available on the internet at http://www.basf.com or in the
Social Media Newsroom at newsroom.basf.com. Now here is where you come in… BASF, “The Chemical Company” is seeking exceptional candidates for a Senior Regulatory Specialist at our San Diego, CA Biotech Center of Expertise. The successful candidate will provide regulatory support to the Director, Biotech Regulatory CoE to ensure compliance with applicable US and international regulations in which the company does business; preparing product submission documentation, and providing guidance to project teams as it relates to application of regulatory requirements. Your responsibilities would include: • Preparing and maintaining regulatory submissions, including U.S. FDA GRAS Notifications, EPA MCAN and PMN submissions, and other international submissions as required • Conducting regulatory assessments, reviewing, and approving manufacturing changes as appropriate • Interfacing with R&D teams to collect relevant information, test reports, and technical discussions for regulatory submissions
• Monitoring changes in international and domestic regulatory compliance issues • Maintaining regular communication with team members to facilitate international registrations and approvals • Assisting in the development of new Regulatory Department procedures
Where you’ll work: The selected individual will join R&D, manufacturing, marketing, business development and sales persons
at the San Diego CA Center of Biotech Expertise. This location develops and commercializes high-performance enzymes for use in industrial processes. Does this sound like the right job for you? Yes? Then we would like to hear from you…Please click “apply”
to get the process started. QUALIFICATIONS: • BASF recognizes institutions of Higher Education which are accredited by the Council for Higher
Education Accreditation or equivalent • Bachelor’s degree in Biology or related field, e.g. Molecular Biology, Microbiology, etc.; MS degree preferred • Minimum of 5 years of experience in Regulatory Affairs, preferably with prior experience in the biotech
industry • Must be able to comprehend, interpret and convey scientific information • Knowledge of FDA food regulations, food cGMP’s, EPA TSCA regulations, and NIH Guidelines for research involving rDNA molecules is highly desirable
• Demonstrated ability to effectively interact with regulatory agencies including FDA • Demonstrated ability to develop, implement and manage programs in support of regulatory compliance
************************************************************** Manager,Commercial Supply Management Gilead Sciences - San Francisco Bay Area Posted 1 day ago
Job description This position is responsible for commercial supplier relationship management with CMOs (contract manufacturing and packing organizations), both internationally and domestic and will coordinate closely across Gilead to insure supply plans and strategies are executed and achieved. This position will drive
performance of the strategic relationship under the direction of the department Director and in conjunction with Commercial Manufacturing, Quality, Development and other Gilead functions. This position will support the Supplier Management program and Risk Management program for commercial supply and will execute the appropriate solutions and strategies. This person will be the
internal interface with CMOs management to measure and drive results, initiatives, and develop collaborative relationships. This position will also coordinate across broad internal functions and act as the product champion to lead the resolution of supply issues to effectively manage uncertainty and/or to mitigate supply risks. This person will be involved with providing visibility to critical supply situations and for escalation to Management and developing and implementing mitigation plans. Desired Skills and Experience Serve as the primary day to day contact to support the relationship between Gilead and the CMO/Supplier •Serve as the production champion/point of contact for specific product franchises to manage and mitigate issues and drive robust supply of product through coordination across commercial functions. •As assigned by department management, manage external manufacturing activities and relationships; international and domestic contract manufacturers. Serve as the day to day internal representative for CMO management and as the POC with the CMOs. •Execute strategies that drive effective operational performance and service levels at CMOs. Strong alignment with Global Planning required and with Commercial Manufacturing and Quality. •Lead initiatives that drive a collaborative and robust relationship and drive alignment between CMOs and Gilead; Business reviews, Performance Metrics, Continuous Improvement, Projects, Risk Management.
•Support and effectively execute Supplier Management and Risk Management plans/activities and cross functional efforts, processes and strategies to insure supply performance at the CMO and within Gilead is achieved. •Utilize advanced analytical tools to identify, quantify and minimize risks in the supply chain
•Negotiate and manage key agreements with CMOs. •Implement and manage joint operating procedures between Gilead and the supplier/CMO it insure effective and strategic execution of the relationship and associated logistics. •Report metrics and lead supplier specific performance improvement initiative and metrics
•Understand the CMO market and capabilities that are consistent with Gilead’s manufacturing requirements. Develop relationships with potential CMOs globally that support Gilead’s future requirements for CMO work. •Coordinates interdepartmental activity with Quality Assurance, Manufacturing, Development and other
functions that support commercial supply. •Work closely with department management to establish standards and policies that support the key supplier/CMO partnerships within each region. Knowledge, Experience and Skills •Ability to influence and work well with others in a proactive and constructive manner. Strong communication skills, both verbal and written with all levels of the
organization •An independent self-starter with the ability to resolve supply chain challenges and implement improvements •Ability to develop, analyze, and leverage key metrics to improve overall business performance
•Proven ability to lead problem solving, build strong relationships and to organize effectively •Business acumen and analytical problem solving skills with an ability to anticipate operational issues and recommend solutions •Strong familiarity with ERP and supply chain systems
•Develop objectives •Expertise in EU and international cGMPs •Demonstrates effective communication skills and the ability to deal across several multi-national sites and organizations
•BS degree in related field required. Advanced degree including MBA or Life Sciences preferred •APICS Certification preferred •Experience in pharmaceutical operations/cGMP environment highly desirable.
Typically Requires: 8+ years of relevant experience in related field and a BS or BA; or 6+ years of relevant experience and a MA/MBA. *Academic Level Bachelors Masters
************************************************************************************ Medical Director, Clinical Development – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) baybio
5/18/2014 18
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 [email protected]. No Work Visa sponsorship is available for this position. DESCRIPTION: • Hands-on participation in the clinical program and trial development process - conceive and execute clinical strategy and provides clinical expertise for the research and development project • Serve as the Medical Monitor for clinical trials (Phase 1 and Phase 2) • Lead preparation of clinical sections of all relevant documents and regulatory filings (Investigator brochure, IND, study reports, etc) • Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan • Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources • Interact in collaborations with strategic partners
• Represent the company at scientific, commercial and financial community meetings and presentations, as well as other public relations opportunities • Responsible for clinical development plan in highly competitive therapeutic areas • Provide input/review study start up documentation, e.g. CRF design, source data verification plans
based on protocol specifications • Attend and provide science support for investigator and consultant meetings and other study implementation workshops • Manage studies and provide expertise on clinical and medical issues to other colleagues and study
site staff • Review study data • Evaluate Serious Adverse Events (SAEs) and provide input on safety reports • Author clinical sections for final study reports
• Participate in preparation for submission activities as appropriate • Assists in the development of publications, abstracts, and presentations EXPERIENCE AND QUALIFICATIONS: • Experience in small molecule clinical development preferred • Ability to direct strategic interactions and partnerships with outside collaborators, such as academic
research groups, corporate partners, CROs and other vendors • Reputation as a leader in the field with sustained performance and accomplishments as evidenced by quantity and quality of publications, patents, regulatory filings and/or other technical documents • Proven abilities in the review and interpretation of complex scientific data in order to form
appropriate clinical opinions • Strong interpersonal, team and collaborative skills, ability to function and influence effectively in a broad multidisciplinary group; consistently looking for win-win solutions to problems • Passion for continued learning and mentoring
• Results-oriented self-driven and motivated individual who enjoys the immediacy of personal effort and impact • MD with experience in the pharma/biotech industry conducting, interpreting human clinical studies with 5 or more years of experience
• Board eligibility/certification in hematology and/or oncology preferred • Knowledge of or experience in hematologic malignancies strongly preferred Margaret Imperiale
****************************************************************** http://www.linkedin.com/groupItem?view=&item=5870552991534166018&type=member&gid=4700652&trk=eml-b2_anet_digest-null-2-null&fromEmail=fromEmail&ut=2-prZqtGIu_Cc1 Currently looking for PhD BD "seekers" in the GI, Urology and Immuno spaces. Company is on the East Coast. Let me know if you want more info. Connie HamptonRecruiter & Coach | Scientific & Executive Search Services| For Employers and Employees in the BioWorld ************************************************************************ http://jobs.bio.org/home/index.cfm?site_id=15768 See 155 jobs in California listed at this site. I’ve listed those posted since May 2, 2014
******************************************************************************** http://sciencejobinsider.com/job_detail/apply/?id=D-d618fedad54741d0f4d0c1a3c2&utm_source=darkstar&utm_source=darkstar&utm_medium=cpc&utm_campaign=scie-gD713HHO-ON2_19&utm_term=D-d618fedad54741d0f4d0c1a3c2#page=entryPage “Associate Director QU Process Validation” Company:
Bayer Location:
Berkeley, CA Date Posted:
Apr 19, 2014
Bayer HealthCare (BHC), an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting
science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women''s Healthcare. As a specialty pharmaceuticals ... more »
************************************************************************************ See current openings in SmartBrief Jobs at https://jobs.smartbrief.com/action/search?searchtype=boardall&briefid=263A5F36-6763-46C7-B399-
4428C3A9FD06&offset=0 You can request that new listings be sent to you directly. ************************************************************************************ http://www.indeed.com/viewjob?jk=a2b60d137a5b2880&l=Fremont%2C+CA&from=simjobs
Principal Technical Manager External Quality Genentech - South San Francisco, CA Date : May 7, 2014
Job Function : Quality & Compliance Company/Division : Pharmaceuticals
Schedule : Full-time Job type : Regular Employee
Job Level : Experienced Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the
United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Location: San Francisco
Principal Technical Manager, Devices and Combination Products- PTQXF Quality Engineering - North America The Quality Engineering manager works independently and provides oversight of quality engineering activities during design development. Be the quality engineering subject matter expert during device development, manufacturing, technology and associated verification and validation.Job Responsibilities: * Works closely with Device Development and device CMOs to assure that combination products maintain their requirements and specifications and are compliant with the Quality System* Liaises with technical groups to review and revise specifications based on design and/or process changes* Supports root cause analysis in the implementation of corrective actions* Responsible for continual improvement activities and liaises with experts to apply appropriate improvement tools* Provides technical consultation on the development of fixtures, methods, test equipment, and tooling in order to continually improve process and products* Establishes quality inspection processes and supports quality activities to ensure that products and processes comply with the relevant requirements of the quality management system.* Supports internal/external audits and vendor qualification, including closing out audit findings and determining proper corrective and preventive actions.* Responsible for planning, organizing, and managing the overall testing activities
of quality functions.* Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required).* Set personal performance goals and provide input to departmental objectives and establish work priorities to meet targets and timelines. Maintain current status on all required job related training
and strive to continuously improve knowledge and skills in quality, compliance and technology. Perform any other tasks as requested by Management to support Quality oversight activities* Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Who You Are BS degree in an Engineering discipline, Graduate degree preferred* 10+ years experience in a
Quality Engineering role for a pharmaceutical or medical device company* Quality Engineer certification (ASQ) recommended* Experience leading and working with internal and external
teams through end-to-end projects* Able to educate teams and organization on Design Controls and related topics* Demonstrated capability of ISO13485, 21CFR820 and ISO14971* Demonstrated capability of applying risk management concepts and tools* Understanding of the biotechnology industry and specifically combination products.* Hands on expertise in one or more areas including secondary packaging, device development, aseptic product
development, and manufacturing* Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing. Experience working in a global environment is a plus. * Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is
preferred* Travel required is approximately 20 - 40% Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity
protections, view the EEO is the Law poster. If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected] .
Technical/Medical Writer Curexo Technologies - Fremont, CA Job Description
The scientific technical writer develops, writes, and edits material for customer manuals, release notes, submissions, clinical documentation, web content, sale collaterals and internal procedures as required. The writer must be able to effectively “translate” highly technical information into end-user appropriate language without sacrificing technical accuracy. The writer will utilize functional
5/18/2014 23
specifications, access medical equipment, and interface with engineers, surgeons and others as applicable to develop content. The technical writer ensures documents meet the company’s high standards for technical and regulatory accuracy, clarity, tone, and style while adhering to aggressive timelines. The writer must also be an experienced project manager, able to represent their area on cross functional teams while managing multiple writing projects simultaneously. Travel Requirements: ≤ 10% Training opportunities and/or medical sites. Job Responsibilities:
Compose medical reports, presentations and other comprehensive materials using correct grammar, punctuation, spelling editing, formatting, and proofreading skills to clearly and concisely provide accurate information.
Maintain Product User Manuals. Assist in writing summaries for regulatory submissions, engineering and clinical reports.
Maintain web content and sales collaterals. Qualifications
A life science degree is absolutely essential.
Minimum five (5) years experience within the medical device industry writing/editing scientific/medical material.
Adobe CS version 5 or 6 prefer. Excellent oral/written communication, research, and interpersonal skills required.
Strong engineering acumen with the ability to read and decipher specs, blue prints, and other technical documents to create end-user friendly procedures.
Excellent project management skills, including participation on cross functional teams Detail-oriented, including the ability to follow directions precisely.
Excellent organizational, analytical, and problem solving skills. Must also be able to work independently on a multiple task work load and produce a quality
product under a tight time constraint. Highly proficient with MS Office, Webworks, RoboHelp desirable.
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Attendance and Punctuality are essential function of the position. .
Additional Information Curexo Technology Corporation offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits. We are an equal opportunity employer and encourage diversity.
Curexo Technologies - 1 day ago - save job - block ************************************************************************************ http://www.indeed.com/viewjob?jk=a31fa9383870c845&from=api&q=(%22medical+device%22)+$80,00
Account Executive III: Healthcare and Life Sciences San Francisco, CA Dell's Healthcare and Life Sciences organization supports 1,000s of healthcare providers, health plans, pharmaceutical, biotech, medical device, diagnostic, and scientific instrumentation customers worldwide. For more than 25 years, Dell has played a critical role in transforming computing, enabling
more affordable and more pervasive access to technology around the world. When it comes to Healthcare, with the level of commitment and focus that Michael Dell has brought in the past 2 years, we have gone through a major transformation from a predominantly hardware player to an end-to-end solution provider. In 2009 we made the first Healthcare specific acquisition of Perot Systems.
************************************************************************************ http://www.indeed.com/viewjob?jk=c6f723a04e206716&from=api&q=(%22medical+device%22)+$80,000%2B&atk=18nglvcs919s26mu&sclk=1&sjdu=5Mmq1YSd2kR8hxoC94gIMsKRGHqEKcE12BbG_5-Xk0Sm9EOwYmbrxs5XX7lzZX0UNeVRnbbcFaXt_39GSMcwKa5mjJYRyJEGhG3dmA-vQ3pn1YzwAUrS7lOviQP6QoT5b8y579oDxeyjBiYnTXJ6H33SqyE2stcy_Ubr763myX4 Sales Account Executive, Mid Market - Healthcare & Life Sciences San Francisco, CA Our team is currently recruiting high-energy, driven Account Executives with relevant knowledge in the Healthcare, Pharmaceutical or Medical device industries with experience in value-driven sales. Ideal candidates should possess strong B2B sales and account management experience selling to the senior executive level. Salesforce.com offers a fast-paced, innovative environment where you will be provided the tools, resources, and outstanding leadership to sell business application solutions. Responsibilities:
Developing and managing relationships within Healthcare, Life Sciences and Pharmaceutical Segment - Building trust and relationships with clients through travel to assigned terr ...
s41uYqUCTG7K5IU7Djo3cPVzjdTWObs_RwFgW7TsW5KcASe9zcQ5iqK4kLAQGNoJzAgFIIpiy3jGHLZafufy0fbyaIorqcTJitO4A Director, International Clinical/Regulatory Affairs
Cepheid - US - Sunnyvale, CA In this critical role of Director of Clinical Affairs (Regulatory), the successful candidate will be part of the Regulatory Affairs management team and develop submission and clinical trial strategy for international countries to support new product development efforts, as well as expansion into new international markets. The director will manage the overall operation of clinical trials including project
planning, budget, resource management and, if required, contract research organization management (CRO). The objective is to maximize the regulatory approval of Cepheid products throughout the world. The candidate will directly manage a team of clinical and regulatory personnel responsible for all Cepheid international submissions.
Provides oversight, supervision, and mentorship to staff (clinical research assistant/clinical research associate). * 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. * Ensures the selection of qualified clinical trial sites. * Develops study related documents and overall direction for the clinical sites to establish protocol development. Uses statistical analysis systems, such as SAS, as appropriate.
Negotiates all aspects of clinical trial agreements. * Monitors clinical trial sites for compliance and performance. * 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
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unit. 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 * Regulatory
Affairs Certification (RAC) * A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology * Experience with US FDA submissions is a plus * Ability to work in an office environment *Date: * 2014-04-04 *Country: * US *State: * CA *City: * Sunnyvale *Postal Code: * 94089 *Category: *
Research & Development - Regulatory Affairs *Job Type: * Full-Time Regular ************************************************************************************
oWNaJVx5WaXkNoHtDgo3E_tgz9q8QoHKLYFGpdzTgV8BQ2QB7WovvCFAdv4rlsOOjdw9XON1NY5uz9HAWBbtOxbkpwBJ73NxDmKoriQuXY_mNX_mqAmhpCdUGgnUWpWX7ZSTP7BI25MpAOeEi8A Sterling Life Sciences - San Francisco, CA 1) Develop submissions for domestic US clearances
2) Work with various project teams and provide regulatory support to assigned teams as needed 3) Ensure for management of preparation and maintenance of US regulatory submissions and other pre-market filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner
4) Determine and document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with regulatory management as needed 5) Control and maintain regulatory records 6) Represent regulatory affairs on various design and development teams by attending team
meetings and providing the required plans, procedures and regulatory decisions 7) Confer with other departments about the regulatory requirements of new product designs and changes to existing designs 8) Review and approve new documents and product changes for compliance and to determine if a
new premarket application is required 9) Assist engineering in maintenance of design history files and related records on an as needed basis and where regulatory responsibilities permit 10) Review technical publications, articles and abstracts to stay abreast of regulatory and technical
developments in the industry More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if
they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling.
5/18/2014 26
Tips: 1) Follow our CEO on Twitter for status-updates about your job application: http://www.twitter.com/sterlinghoffman 2) Add our CEO on Facebook: www.facebook.com/angel.mehta99 We will try to respond to your questions privately via Twitter or Facebook only. ********************************************************************************* http://www-gene-com.careerliaison.com/careers/detail/00431856/Device-Development-Document-Control-Technical-Manager?_CL_SOURCE=18260109&jtsrc=www%2Eindeed%2Ecom&jtsrcid=1789&jtrfr=http%3A%2F%2Fwww%2Eindeed%2Ecom%2Fviewjob%3Fjk%3D7aa6ec9b5368bf84%26from%3Dapi%26q%3D%28%2522medical%2Bdevice%2522%29%2B%2480%2C000%252B%26atk%3D18ngl5s0k19vi7o0%26sclk%3D1%26sjdu%3D5Mmq1YSd2kR8hxoC94gIMsKRGHqEKcE12BbG%5F5%2DXk0Sm9EOwYmbrxs5XX7lzZX0UrT
p1OVK62YmN5pe%2D3jM8FzUam7RLDwDVX9FX0xajtR9n1YzwAUrS7lOviQP6QoT5b8y579oDxeyjBiYnTXJ6H33SqyE2stcy%5FUbr763myX4&src=JB-12568 Device Development Document Control Technical Manager
South San Francisco, California JOB ID: 00431856 Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-
threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position
The Document Control Technical Manager will be responsible for reviewing design control documentation supporting the Design History File (DHF) for combination products (medical devices) to ensure compliance with internal Pharma Quality System (PQS) documents and relevant Health Authority expectations specifically device design controls. The candidate will closely interface with the document authors and
Quality to ensure any issues are resolved prior to routing for approval in the electronic DHF system. The candidate will ensure that new documents entered into the eDHF are inspection-ready with respect to compliance with FDA and ISO regulations. The candidate may also supervise document control specialist(s).
Responsibilities: Develop solid expertise with global, company-wide Pharmaceutical Quality System (PQS) and
business processes to apply to design and development documents for medical devices and
combination products. Facilitate implementation of PQS documents and local impact assessment process Act as document submission coordinator for new design and development documents Edit documents to ensure alignment with formatting standards and quality requirements – Good
Documentation Practices Check technical information in design and development documentation for compliance with PQS
Document all compliance gaps and make recommendations for gap closure Build key partnerships and collaborate with Quality single-point-of-contact and device teams to
ensure achievement of desired outcomes
Work with authors to edit documents to bring them into compliance with PQS and design control regulations
Perform supervisory activities for document control specialist(s), as require.
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Perform other related duties (as defined by Device Development management) that may be required based on corporate, department, and business needs
Set personal performance goals and provide input to departmental goals and project prioritization Who You Are B.S degree or equivalent; preference for engineering or technical field Minimum 10 years’ experience in medical device or combination product design and development
environment with emphasis on design control Extensive knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical
standards relative to device development. Understanding of international regulations and standards is a plus.
Knowledge & expertise in applying Combination Products GMP rule is desired Expertise in technical writing and editing Minimum 3 years supervisory experience Must be detail-oriented with strong organizational skills Strong interpersonal, verbal, and written communications skills
The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability,
marital & veteran status. For more information about equal employment opportunity protections, view theEEO is the Law poster. If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].
SR. MANAGER, COMMERCIAL OPERATIONS Menlo Park, CA 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 technologi ...
Abbott - Santa Clara, CA Division Counsel-1300000960 ##DescriptionAbbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices,
nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.Job DescriptionResponsibilities will include counseling on complex regulatory issues such as FDA laws, regulations, and guidance documents relating to medical device advertising and promotion, scientific exchange, and lifecycle management; the development, approval, and marketing of medical devices; handling adverse events; and regulatory agency strategy on inspectional and product safety issues, communications, and product quality issues. Responsibilities also include counseling on fraud and abuse issues relating to medical device sales and marketing activities, including the Anti-kickback Statute and False Claims Act, as well as contract and pricing strategies such as discounts, rebates, and bundling methodologies.Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Identifies highly complex legal issues related to assigned matters; develops alternative solutions, and implements resolution Resolves complex to highly complex legal matters in practice area independently Leads cross-functional projects Possesses in-depth knowledge of Abbotts businesses supported and knowledge of the broader business impact Keeps abreast of changes in laws that affect client areas Regularly negotiates independently with customers, suppliers or government agencies on matters of strategic importance that affect a substantial portion of Abbotts business or areas of
significant importance to senior management Selects and directs the work of outside counsel, defines project objectives and manages project Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company.
Advises Managers, Directors, Division Vice Presidents and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice. Serves as a recognized resource for both management and other attorneys on innovative ideas in highly complex areas of the law.##Qualifications Juris Doctor Degree Minimum of 10 years of experience and demonstrated
expertise in providing legal counsel on FDA regulatory and compliance issues relating to medical devices with a major corporation or law firm. Must have demonstrated ability to perform successfully in cross-functional teams, with the ability to lead, influence, and mentor both attorneys and business partners.
Must have ability to handle multiple projects in a fast-paced environment and exercise sound commercial and legal judgment. In addition to top-notch legal skills, must have excellent interpersonal, communication and organizational skills. Prior government experience is also beneficial.Significant Work Activities and Conditions Continuous sitting for prolonged periods (more
than 2 consecutive hours in an 8 hour day)Job Classification: ExperiencedJob: LEGALPrimary Location: USA-California-Santa ClaraOrganization: GENC-GenCounselTravel: Yes, 15 % of the TimeSchedule: Full-timeShift: DayReq ID: 1300000960
O9jEvVAIMnz4z5TB5Bjc_3zaRpApRZPmSj_P_zW3ctAABi_4i_KMpG3MGq69lzCprLU_0Djk_iqilaF2-isszsEGKLY Director of Clinical Affairs
DFINE Inc. - San Jose, CA Position Summary: Primary responsibility is for the management, direction and strategic development of clinical studies and clinical affairs personnel in support of Company goals and objectives. Function as contact person
for all issues related to on-going or proposed clinical studies, or the resources required to support such studies. Develop business relationships with clinical investigators and their staff. Authorities: Has authority to make decisions and implement programs/action items within the specific province of clinical sciences.
Duties and Responsibilities: -Manage the clinical department: -Staff and manage clinical affairs department personnel -Budget planning, head count, hiring, training, documentation
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-Planning of quarterly and annual objectives -Measure and report clinical metrics -Ensure that the department is on track with the clinical objectives weekly -Weekly staff meeting planning -Manage team in positive manner, minimize turn-over, team oriented -Outsource appropriate tasks as needed (i.e., independent CRAs/CROs, statistics, medical writers) -Oversee all sponsored clinical trials and registries: -Maintain working relationships with all Principal Investigators and site clinical study personnel -Collaborate in authoring of clinical protocols -Develop and implement the DFINE STAR Registry -Develop and periodically review and refine clinical research related SOPs --Ensure development of all materials necessary to run the clinical trials (case report forms, investigator brochures, monitoring plans, etc.) -Create and foster clinical site relationships, submission of protocols, negotiation of contracts and budgets, performance of study cases, and completion of subject follow-up -Ensure adequate support to all sites with IRB/EC and contract approvals (including legal review) and
annual reports -Ensure that all sponsored trials adhere to the appropriate legal, ethical and corporate requirements, as well as complying with local, national and international regulatory requirements and standards including FDA regulations to support US and international regulatory submissions
-Collaborate in developing and executing the company’s clinical publication strategy, including manuscripts, meeting abstracts, and book chapters -Provide and adhere to project management timelines for trial completion, data collection, analysis and publications
-Ensure the Sales team is aware of, and when necessary trained on, DFINE clinical trials and STAR Registry -Other duties as assigned -Clinical liaison to other department / project teams. Specific examples include:
-Collaborate and coordinate activities with OUS clinical personnel (GmbH and distributors) -Marketing support to ensure accuracy of marketing literature, physician and patient labeling (brochures, booth graphics) -RA/QA support by reporting of clinical studies in support of regulatory submission and product certifications, adverse event reporting, clinical trial complaints
-Reimbursement support via reporting of trial data o Support sales training clinical data related content -Provide monthly, quarterly and annual clinical objectives updates for intra-departmental and management review
-Provide clinical study/registry metrics for monthly review -Conduct Investigator meetings as required for sponsored trials -Attend relevant scientific/medical meetings as needed -Maintain current on clinically related literature
Position Requirements: -BA/BS Degree. MS or PhD degree preferred with emphasis in life sciences, medicine, or related field -Preferred 5-10 years experience in management of clinical affairs group in a medical device company -Excellent written & oral communication skills
-Proficient with MS Office Suite Applications -Basic clinical research statistical method experience -Thorough understanding of Good Clinical Practices, ICH and applicable regulations regarding research and regulation of medical devices
Requirements: Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be
required by their supervisor. ****************************************************************************************************
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http://www.indeed.com/viewjob?jk=cdc4a61873208118&l=San+Jose%2C+CA&from=recjobs SR REG AFFAIRS SPEC Abbott Laboratories - Milpitas, CA Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. Follow us on LinkedIn Primary Job Function As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide
support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual
may prepare and submit documentation needed for registration worldwide or may oversee such preparation. Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: Strategic Planning:
Assist in SOP development and review
Provide regulatory input to product lifecycle planning Continue to revisit and compare regulatory outcomes with initial product concepts to make
recommendations on future actions Assist in the development of regional regulatory strategy and update strategy based upon
regulatory changes Understand, investigate and evaluate regulatory history/background of class, disease/
therapeutic/diagnostic context in order to assess regulatory implications for approval Determine trade issues to anticipate regulatory obstacles
Determine and communicate submission and approval requirements Participate in risk-benefit analysis for regulatory compliance
Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities Monitor impact of changing regulations on submission strategies Monitor applications under regulatory review Monitor and submit applicable reports to regulatory authorities
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Postmarket:
Maintain annual licenses, registrations, listings and patent information Assist compliance with product postmarketing approval requirements Review and approve advertising and promotional items to ensure regulatory compliance Assess external communications relative to regulations
5/18/2014 31
Review regulatory aspects of contracts Assist with label development and review for compliance before release Submit and review change controls to determine the level of change and consequent
submission requirements Analyze the input of cumulative product changes to current product submissions Contribute to the development and functioning of the crisis/ issue management program Ensure product safety issues and product-associated events are reported to regulatory
agencies Provide regulatory input for product recalls and recall communications
Job specific responsibilities may include (choose applicable areas and expand as appropriate); Medical writing Advertising and promotion Labeling Controlled substances (e.g. DEA) Restricted substances (e.g. REACH) Compendial / standards
Import / export Country specific regulatory support
Comments
Individual may provide direction and guidance to exempt and/or skilled non-exempt levels of employees. Also may be asked to evaluate performance of and assist in career development planning.
Position Accountability / Scope Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met.
Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Work is reviewed upon completion for adequacy in meeting objectives. Individual is recognized as an expert in work group.
Influence/Leadership:
Understands business environment and relates extensive knowledge of internal and external activities to trends.
Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
Participates in the development of others by facilitating training and providing feedback and guidance.
May lead a cross-functional project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff. Exercises judgment independently.
Planning/Organization: Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.
Decision Making/Impact: Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve
organizational objective. Qualifications
Minimum Education Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology,
5/18/2014 32
pharmacy, pharmacology), math, engineering, or medical fields is preferred. Minimum Experience / Training Required 2-3 years of experience in regulatory preferred. 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Background / Skills / Knowledge Regulatory Knowledge of (as applicable):
Regulatory history, guidelines, policies, standards, practices, requirements and precedents Regulatory agency structure, processes and key personnel Principles and requirements of applicable product laws
Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs) Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial trade requirements,
agreements and considerations Domestic and international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory process
Communication Skills or Ability to:
Communicate effectively verbally and in writing Communicate with diverse audiences and personnel Write and edit technical documents Work with cross-functional teams
Work with people from various disciplines and cultures Negotiate internally and externally with regulatory agencies
Cognitive Skills or Ability to: Pay strong attention to detail Manage projects
Create project plans and timelines Think analytically Organize and track complex information Exercise judgment within broadly defined practices and policies in selecting methods,
techniques and evaluation criteria for obtaining results Has broad knowledge of various technical alternatives and their potential impact on the
business Exercise good and ethical judgment within policy and regulations
Use in-depth knowledge of business functions and cross group dependencies/ relationships Define regulatory strategy with supervision Follow scientific arguments, identify regulatory scientific data needs and with supervision solve
regulatory issues
Significant Work Activities and Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Policy Manager/Senior Policy Manager, Public Policy & Reimbursement South San Francisco, California JOB ID: 00419425
Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position Policy Manager/Senior Policy Manager, Public Policy & Reimbursement Position Overview/Job Responsibilities:
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Genentech Government Affairs’ Public Policy and Reimbursement team is seeking a qual ified policy manager/senior policy manager candidate to monitor and analyze numerous public payer activities and trends, including coverage, coding, and payment policies at the national level for both Medicare and Medicaid with a specific focus on oncology. Specifically, the policy manager/senior policy manager will help recognize, assess, and communicate key policy issues that may impact Genentech and the biotechnology industry in both the short- and long-term to key internal and external stakeholders. He or she will focus on the impact of public sector trends and initiatives on Genentech with respect to patient access, reimbursement, and customer satisfaction. He or she will translate policy developments into meaningful guidance and strategic advice and will represent the Public Policy and Reimbursement team at internal and external meetings. He or she also will be responsible for managing projects effectively and efficiently, and will be required to take initiative to identify key issues and help organize and assist the efforts of other team members as appropriate. Who You Are Qualifications:
A BA or BS is required; a graduate degree (MS, MPH, MPP, JD or MBA) is strongly preferred. Qualified candidates should have a minimum of 8 years of relevant post-college healthcare policy
experience (examples include key government agencies such as HHS, CMS, CBO, OMB, or FDA; Congress; healthcare consulting firms; pharmaceutical, biotechnology, diagnostic, hospital,
managed care or other healthcare industries; or patient, provider or trade associations). Experience working at or directly with CMS is preferred. Candidates should have an advanced understanding of the federal regulatory processes, federal
regulatory bodies that monitor and implement the health programs, healthcare policy development,
and the administrative structure of funding sources for government agencies. An advanced understanding of public payer (Medicare/Medicaid/340B program) coverage, coding,
and payment policies is also required. Candidates should also have experience in oncology, or have the ability to quickly learn the science
of this disease state, the product markets, business and patient needs. Core Competencies:Qualified candidates should possess the following core competencies: Research and Analysis: Strong research skills, knowledge of key sources of information and
contacts on public payer issues, as well as the ability to tie research results and policy initiatives directly to Genentech’s business.
Problem Solving: Superior problem solving skills, including the capability of applying previous experience to complex policy issues, and the ability to conduct or delegate qualitative and quantitative analyses.
Writing: Ability to write and edit business documents (e-mails, memos, and PowerPoint
presentations) clearly and succinctly in a timely manner, as well as the ability to ensure content accuracy, appropriate tone, and attention to detail to ensure work is of superior quality.
Speaking/Presentations: Comfort and ability to present information to large group of internal colleagues and external audiences including customers.
Word, PowerPoint, Excel: Advanced level of understanding of Microsoft Office, including PowerPoint, and Word formatting and graphics, and Excel spreadsheet programming.
Project Management: Strong planning and organization skills with the ability to set priorities effectively and efficiently, identify areas that need further research, and multi-task on a number of
issues while notifying team members and supervisor of work progress in a timely and appropriate fashion.
The manager/senior manager should be a leader who is willing and able to take responsibility and ownership for following and analyzing key public payer issues. Qualified candidates should also take
initiative to further explore areas important to both Government Affairs and Genentech while motivating and working collaboratively with other team members. The manager/senior manager will work under limited direction and proactively notify his or her supervisor with work priorities and timelines; work will be reviewed for soundness of judgment and overall adequacy.
The position is located in Genentech’s Headquarter Office in South San Francisco, CA. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability,
5/18/2014 35
marital & veteran status. For more information about equal employment opportunity protections, view theEEO is the Law poster. If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected]. ************************************************************************************ http://www.indeed.com/viewjob?jk=6ae89060bbefee30&l=Hayward%2C+CA&from=recjobs Manager/Senior Manager, Regulatory Affairs Audentes Therapeutics - San Francisco, CA Specific Responsibilities
Oversee IND, CTA maintenance, and the submission of amendments applicable to the Company’s gene therapy drug candidates
Support planning, preparation, and submission of INDs and CTAs working with internal teams and external consultants
Provide strategic insight to the project team regarding product development plans in the Company’s orphan drug indications, wedding regulators’ guidance with the strategic and scientific imperatives of the Company
Manage interactions with FDA and/or other regulatory authorities in specific areas, as directed
Perform research on any relevant regulatory precedents that may be applicable to Audentes programs
http://www.indeed.com/viewjob?jk=aa99cb82bf51564c&l=Fremont%2C+CA&from=recjobs Regulatory Affairs Associate II/III Impax Laboratories - Hayward, CA
Position Summary: Independently prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include ANDAs, amendments, supplements, annual reports. Represent Regulatory Affairs in project teams and provide regulatory guidance to R&D and Operation teams as appropriate.
Essential Duties/Responsibilities:
Prepare INDs, ANDAs, and DMFs as required Represent department as team members on interdisciplinary pre/post approval project teams.
Provide regulatory guidance as appropriate. Prepare change control requests for completeness and accuracy; assess impact of change to
the approved ANDA and review assessments of more junior staff Prepare, review and submit high quality responses to questions from regulatory agencies
worldwide with minimal guidance. Prepare post approval submissions such as Annual reports, Periodic Adverse Event Reports,
CBEs, CBE-30s and PAS’s to support the commercial business Demonstrate Proficiency in the utilization of document publishing systems to insure high
quality filings to FDA Maintain all databases and support systems used to insure compliance for Impax products Participate and take an active role in all GMP and departmental training to insure compliance
with GMPs and guidelines.
Keep abreast of global regulatory knowledge and initiatives including ICH, EMEA, and other regulatory intelligence sources and aid in training other functions in the requirements
Assume additional responsibilities such as review and approval of formulations from the IIG perspective, review safety (toxicology)
Formulate strategies to maintain submission/corporate goals.
Perform first line review of submissions prepared by more junior staff Serve as Regulatory designee and back up for RA management Assists in developing less senior associates in the review of change requests and provide
guidance to other associates in the preparation of FDA submissions.
Minimum of a Bachelor’s degree, preferably in Chemistry or a related, scientific discipline or equivalent combined education and relevant Regulatory Affairs experience.
Minimum of 3-5 years of experience working in a Regulatory Affairs Department is preferred. Ability to manage timelines in a project team environment. Experience with regulatory submission eCTD preparation software is preferred Familiar with the preparation and maintenance of regulatory documents Demonstrate thorough knowledge of all FDA requirements necessary to insure compliance of
Impax submissions RAC certification is suggested Must possess excellent attention to detail, written and verbal skills. Experience with Windows-based programs such as Word and Excel is required. Ability to work successfully in a fast-paced, entrepreneurial environment and effectively handle
multiple projects
************************************************************************************ http://www.indeed.com/viewjob?jk=0fe28e38dbdb2498&l=San+Jose%2C+CA&from=recjobs Sr. International Regulatory Affairs Specialist Job
Stryker - Fremont, CA Requisition ID: 29593BR
Job Title: Sr. International Regulatory Affairs Specialist Division:
Neurovascular Business Unit: Business Function:
Regulatory Affairs Business Sub Function: Regulatory Affairs
Country: United States
State: CA City:
Fremont Shift: 1st
Job Description: POSITION DESCRIPTION: Responsible for the coordination and preparation of document packages for regulatory submissions in one or more of the following geographic regions: United States, Europe, Japan, Canada, and
Intercontinental. Under general supervision of the RA Project Manager or RA Department Manager or Director.
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- Prepares complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, HDE, HDE Annual Report, Shonin, PLA, CE-Mark Design Dossier, CE-Mark Technical File, Intercontinental Dossiers, Certificates to Foreign Government. Ensures that existing approvals and documentation are maintained. Communicates with in-country RA personnel to facilitate global clearances/approvals.* - Develops global regulatory strategies for project teams. Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies. Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors, and proactively shares this information. * - For new, routine or ongoing issues, communicates with regulatory agencies. Prepares for meetings with regulatory agencies and investigators. * - Mentors others on a regular basis. Is not expected to supervise others.
- Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements global regulatory action plans based on the changes. Organizes and maintains RA files.*
- Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to: standards, guidelines, regulations, and regulatory approvals/clearances.*
- Provides regulatory support to other Stryker personnel to facilitate cross-divisional leverage. - Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs as needed to support departmental functions and Stryker’s Quality
System. Prepares and delivers training programs to the department and other functional groups to ensure compliance. - Understands: Stryker’s systems, biocompatibility requirements, CMDRs, Design Control, Medical Device Directive, Essential Requirements, ISO 13485 , labeling requirements, Quality System
Regulation, export requirements, and regulatory requirements of pertinent regions. Monitors changes in the regulatory environment, evaluates impact, and communicates to interested parties. - Uses existing project management tools, and develops/implements new tools as needed.
- Performs responsibilities required by the Quality System and other duties as assigned or requested. Qualifications/Work Experience:
Senior Regulatory Affairs Specialist Thermo Fisher Scientific - San Jose, CA Expertise Quality Assurance Education Bachelors Job Type Full-time Location United States -
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California - San Jose Job Level Experienced Posting date: May 2, 2014 Position Summary: The Senior Regulatory Affairs (RA) Specialist is responsible for providing technical support to regulatory affairs management in order to remain in compliance with FDA, and all other U.S. and international regulatory requirements . The Senior RA Specialist will prepare US and International regulatory submissions, including 510(k)’s, for LSMS products, including IVD. Key Responsibilities: Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including International Authorities. Prepares international documents, including Technical Files. Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products. Partners with cross functional teams by providing regulatory guidance and support to product
development teams for strategic planning, design and development, and post-market surveillance and compliance activities. Reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments.
Provides regulatory advice to project teams. Creates detailed Regulatory Plans. Includes in-depth team involvement, including Core Team membership for complex projects. Evaluates proposed product modifications for Regulatory impact on a world-wide basis.
Completes Regulatory Assessments as needed. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies’ questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and
relevant guidelines. Develops timelines for submissions under the direction of senior regulatory affairs staff. Provides solutions to extreme complex problems. Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
Keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for Regulatory Affairs processes. Reviews and approves proposed labeling, packaging, advertising and promotional materials after
evaluating conformance to regulations. Reviews and provides regulatory authorization related to ongoing product design changes and field action investigations.
Minimum Requirements/Qualifications: A minimum of a Bachelor’s Degree is required, preferably in a scientific discipline. Approximate experience of 6 to 8 years in the medical device and/or pharmaceutical industry OR an Advanced Degree and a minimum of 3 years of regulatory experience in the medical device and/or
pharmaceutical industry is required. LCMS or Clinical Chemistry experience is preferred. Solid knowledge of US FDA regulations and review processes as well as experience interacting with US FDA is required. Practical experience in a medical device Regulatory Environment, preparing US submissions and a
successful track record interfacing with the FDA is required. Technical Files experience is a plus. Experience in Asia/Pacific and South American regulations and submissions is preferred. Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required. Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
5/18/2014 39
Being detail-oriented, while having the ability to handle multiple ongoing projects/tasks is required. This position has not been approved for Relocation Assistance. ************************************************************************************ https://jobs.smartbrief.com/action/listing?listingid=A821FE13-10EF-4C23-ADE6-752D9DDC4462&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary Date Posted: 4/25/14 Location: Santa Ana, CA Years Experience:
3+ Catheter Engineer Asahi Intecc USA, Inc. Job Description
Job Title: Catheter Engineer ASAHI INTECC develops and supplies wire materials and products to the industries inside and outside Japan using an integrated in-house production system based on our four advanced core technologies that
covers everything from selection and treatment of raw materials to manufacture of final products. In the medical field, ASAHI INTECC develops and manufacturers Asahi brand cardiovascular products such as PTCA guidewires, Guide catheter, PTCA balloon catheter, as well as OEM products, some of which have become world standards.
At ASAHI INTECC our mission is to create products that perfectly match the vision of each customer. That commitment is reflected in each strand of ultra-fine wirerope that we create and each of the final products that we manufacture. [JOB Description] This position is responsible for designing, developing, and commercializing vascular catheter.
[Your responsibility includes] Design, development and prototyping of vascular catheters. Design a manufacturing processes and technologies including bonding, joining, welding, braiding, coiling, plastics laminating.
All research and development activities for catheter development including making a prototyping, prototype product testing. Working on product documentation including DHFs, drawings, test protocols etc.. Leading teams from conception through commercial launch of medical devices by developing design and
process failure mode & effects documents. Working with Design Engineers and Quality Engineers to successfully transfer new products into production and manufacturing. [Requirement]
BS or MS Degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering or related Engineering Field. * 3+ years of neurovascular / cardiovascular / endovascular medical device industry experience developing catheter or catheter based medical device.
Strong understanding of CAD and Computer Aided Design tools Experience working within FDA, ISO guidelines (Design Controls) and compliance with internal Quality Systems. [Benefit] 401K with company matching
Group Insurance Paid holidays, sick and vacation times Tuition Aid
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************************************************************* Facilities Engineering Manager Gilead Sciences - San Francisco Bay Area Job description We are currently seeking a Manager of Engineering to support our build out our 96 acre corporate campus headquarters in Foster City and serve as the technical equipment/systems expert globally. Essential Duties and Job Functions Responsible for managing a small team of engineers to oversee engineering equipment/system standards and to provide technical support to Maintenance, EHS, and R&D. Project support include review of MEP and Automation design documents for large ground up construction of office and lab buildings to equipment/system replacement and upgrades. This also requires oversight of all technical engineering standards, methods and procedures for the design, modifications, and maintenance of facilities equipment, facilities and processes. Coordinates engineering support workload. Provides engineering expertise and guidance in planning, financial justification, start-up activities, scale up processes, implementation, process improvements, and validation. Manages external technical vendor relationships and negotiates contracts. Manages budget for
engineering related projects and activities. Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within generally defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Contributes to the development of new concepts, techniques, and
standards. Ensures solutions are consistent with organization objectives. Candidate must be committed to building and maintaining a lean world class engineering team. Desired Skills and Experience Must be able to develop solutions to a range of moderately complex problems, which require the regular
use of ingenuity and innovation. Excellent verbal and written communication skills and interpersonal skills are required. Typically requires a BS degree in Engineering and minimum 10 years of relevant experience in related field and a minimum of 4 years in management.
A MA/MBA degree can be substituted for 2 years of related experience. *Academic Level Bachelors/Masters
**************************************************************************** Jobs are increasing in the industry. I’ve listed many below but suggest you look at https://www.linkedin.com/vsearch/j?type=jobs&keywords=life+science+in+California&orig=GLHD&rsid=20224521398609543903&pageKey=voltron_job_search_i
Also check the latest listings at the BIO website *********************************************************************************** Apply on company website
Principal Scientist Fermentation Bayer - Davis, CA Posted 1 day ago Job description
The primary responsibility of this role, as Principal Scientist Fermentation, is to provide technical leadership in fermentation process development and manage fermentation teams and projects. The ideal candidate is highly versatile, energetic and has extensive technical background and excellent organizational and communication skills and the ability to work in collaborative environments
The incumbent will: • Provide technical leadership for fermentation teams and projects; • Develop research strategies, approaches and plans for fermentation projects; • Manage day to day fermentation research operation to meet project goals and timelines;
• Apply the latest knowledge of microbial physiology, secondary metabolism and biosynthetic pathways to media design, process optimization and strain improvement; • Collaborate with scientists, engineers, and technicians in formulation and other departments; • Evaluate fermentation options, technical feasibilities, and costs for new projects;
• Keep abreast of current literatures and the state of the art in fermentation science and their potential applications to the company’s projects. Desired Skills and Experience The selected candidate is required to possess the following: • Ph.D. in microbiology, chemical engineering or related science with a minimum of 6 years of experience in fermentation processes including 2 years of supervisory experience in industrial bioprocess settings; • Proven track record of effective team building and people management skills; • Excellent organizational and communication skills and the ability to work in collaborative environments; • Strong background and extensive experience in fermentation science and fermentation operation from lab to production scale; • Hands-on experience in fermentation equipment and associated on-line & off-line analytical methods; • Experience in statistical design of experiments related to fermentation media optimization and process improvement; • Good working knowledge in industrial strain improvement; • Previous experience with fermentation and production of biologicals for agriculture is highly desirable.
Salary and grade level will be commensurate with experience and/or education level. Bayer CropScience (BCS), a subgroup of Bayer AG is one of the world's leading innovative crop science
companies in the areas of crop protection, non-agricultural pest control, seeds and traits. The company offers an outstanding range of products and extensive service backup for modern, sustainable agriculture and for non-agricultural applications. Bayer CropScience has a global workforce of 20,700 and is represented in more than 120 countries.
Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our
mission statement “Bayer: Science For A Better Life". __________________________________________________________________ Principal Scientist Fermentation Bayer - Davis, CA Posted 1 day ago
Job description The primary responsibility of this role, as Principal Scientist Fermentation, is to provide technical leadership in fermentation process development and manage fermentation teams and projects. The ideal candidate is highly versatile, energetic and has extensive technical background and excellent
organizational and communication skills and the ability to work in collaborative environments The incumbent will: • Provide technical leadership for fermentation teams and projects;
• Develop research strategies, approaches and plans for fermentation projects; • Manage day to day fermentation research operation to meet project goals and timelines; • Apply the latest knowledge of microbial physiology, secondary metabolism and biosynthetic pathways to media design, process optimization and strain improvement;
• Collaborate with scientists, engineers, and technicians in formulation and other departments; • Evaluate fermentation options, technical feasibilities, and costs for new projects; • Keep abreast of current literatures and the state of the art in fermentation science and their potential applications to the company’s projects.
Desired Skills and Experience The selected candidate is required to possess the following: • Ph.D. in microbiology, chemical engineering or related science with a minimum of 6 years of experience in fermentation processes including 2 years of supervisory experience in industrial bioprocess settings; • Proven track record of effective team building and people management skills;
• Excellent organizational and communication skills and the ability to work in collaborative environments; • Strong background and extensive experience in fermentation science and fermentation operation from lab to production scale; • Hands-on experience in fermentation equipment and associated on-line & off-line analytical methods;
• Experience in statistical design of experiments related to fermentation media optimization and process improvement; • Good working knowledge in industrial strain improvement; • Previous experience with fermentation and production of biologicals for agriculture is highly desirable. Salary and grade level will be commensurate with experience and/or education level. ****************************************************************************** Apply on company website Scientist - Protein Engineering Genentech - US - California, South San Francisco Posted 3 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.
The Position We are seeking an energetic and creative scientist to join the Early Discovery Biochemistry Department and lead a group focused on the application and development of innovative protein diversity/molecular evolution technologies. Our department engages in a diverse range of research, including engineering of protein function, enzymology, development of molecular evolution methods and
exploration of chemical aspects of molecular recognition. Candidates should have experience in molecular evolution technologies and expertise in protein biochemistry and/or biophysics coupled with research interests in protein structure-function studies and protein-protein interactions relating to early lead discovery or biological target validation. The successful candidate is expected to develop novel technologies within his/her own group that will have application in the areas of molecular recognition and
drug discovery, and to manage internal collaborations with other Genentech research and development groups on therapeutically relevant projects. Who You Are Requirements: Applicants should have an established record of innovative research in molecular recognition and/or
molecular evolution technologies. Preference will be given to candidates with significant experience in the application and development of protein and/or peptide phage display methods. Qualifications include a Ph.D. in chemistry, biochemistry, or a related field, as well as a record of significant postdoctoral and independent research accomplishments as evidenced by a strong publication record in top-tier journals.
The ability to tackle interdisciplinary problems and strong communication skills are essential. The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer. _____________________________________________________________________________________ Apply on company website
Technical Development Research Associate, Protein Analytical Chemistry Genentech - US -CA-South San Francisco Posted 3 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. The Position A Technical Development Research Associate position is available in the Protein Analytical Chemistry Department, which is a part of the larger Analytical Development & Quality Control (ADQC) organization. The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics using techniques such as high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), peptide mapping and mass spectrometry (MS), and for routine analytical characterization in support of ongoing development projects.
The candidate will accurately carry out experiments and protocols, interpret data, and troubleshoot problems, present results with review/feedback, and consistently produce high quality work. The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents. Additionally, the individual will be responsible for presenting results and
experimental information to internal and external departmental colleagues and writing internal reports. Who You Are
B.S. degree or equivalent in biochemistry, chemistry, or analytical chemistry with at least 1-2 years of relevant laboratory experience in biopharmaceutical industry.
The candidate will have a basic technical proficiency in commonly used protein analytical techniques such as HPLC (size exclusion, ion exchange, reversed-phase, etc.), capillary electrophoresis
(CE), and peptide mapping. Some experience with mass spectrometry methods for protein analysis is a plus but not required.
Experience with method development and validation, and cGMP working environment is a plus. Familiarity with analytical methods for analysis of protein glycosylation is a plus. The candidate should possess good scientific reasoning abilities, initiative, strong organizational,
and show consistent success in performing routine experiments. The motivation to learn new skills, a willingness to take on new challenges, and scientific curiosity are also valued attributes of a successful candidate.
Excellent oral and written communication, documentation, and interpersonal skills are required to
facilitate collaboration with others. Ability to follow detailed verbal and written instructions. Must be self-motivated and meet timelines
efficiently and productively.
The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer.
**************************************************************************** Apply on company website. ** TO APPL, please copy and paste the following link**
https://external-levlad-arbonne.icims.com/jobs/1554/manager%2c-r%2bd-formulation/job R&D Formulations Manager Arbonne International - Orange County, California Area
Job description We are currently seeing a R&D Formulations Manager that will supervise a formulations team responsible for new product development, provide leadership, creativity and technical support to the R&D formulators; coordinate projects and optimize project flow with in the lab Job Responsibilities Manage a team of formulators and a support group.
Interface with Sales, Marketing and Regulatory on formulation development. Work closely with formulators to develop formulation strategies and ensure project deadlines are
met. Review lab submissions and documents to ensure all projects meet cost target, product
performance, aesthetics and are regulatory compliant. Provide technical support to formulators for product development and to resolve testing failures. Conduct research into new and innovative products through search of journals and trade
publications as well as meeting with vendors. Desired Skills and Experience
Job Qualifications
B.S. in Chemistry or related science with at least 5 years of experience as a R&D Formulator for high-end or natural/organic skincare and hair care products.
3+ years of supervisory/management experience. Experience dealing directly with marketing and/or clients to develop products. Experience supervising scale-up and manufacturing process. Comprehensive knowledge in all related testing for formulation and claim substantiation.
Experience working in a cGMP environment and comprehensive knowledge of OTC regulations. Strong computer and communication skills. Natural Products Group, LLC is the parent of Arbonne International, LLC and Levlad, LLC. Arbonne crafts
premium personal skincare, beauty and wellness products for both inner and outer health using botanical ingredients and innovative scientific discovery. Levlad is a leading manufacturer and marketer of natural and organic personal care products for Arbonne and its own product brand, Nature’s Gate, as well as a growing base of private label customers.
Why work for Levlad? Because it doesn’t feel like work! Working for Levlad is a truly unique experience; there’s no other company quite like it. Working with great people in a welcoming, exciting environment and that’s just the beginning. On a daily basis you’ll get the opportunity to learn a wide range of new things and to contribute
your talents to a dynamic team of people. These are exciting times for Levlad and Arbonne. Our company is in the midst of extraordinary growth and we’re looking for the right people to become a part of it. People like you!
Arbonne Scientific Advisory Board Arbonne relies on a renowned group of medical experts providing insight, information and innovation. Their goal is to extend our commitment to quality, scientific integrity and healthy lifestyles
The Arbonne Scientific Advisory Board is comprised of leading professionals in science, medicine, health, wellness and nutrition. Our Advisory Board supports the vision and voice of Arbonne by providing additional insight on the
development, implementation and assessment of both products and informational content for our customers, company and community. The Advisory Board members lend their expertise and knowledge directly into the research and development process.
5/18/2014 45
********************************************************************************** Posted by Yvonne Verburgt, Senior Director Business… https://www.linkedin.com/jobs2/view/13509215?trk=eml-b2_group_digest-groupjobpost-job-0 Director Formulation Development Formex - Orange County, California Area Posted 2 days ago Job description The Director of Formulation Development is responsible for leading formulation development projects for our clients. Activities will include developing prototype formulations and processes, defining and executing scientific plans , tabulating and evaluating process and analytical data and working with other scientists and team members. The director will have direct involvement in R&D and manufacturing activities. The successful candidate will be a valuable group member and excellent group leader. The Director of Formulations will also be involved in discussions with potential clients, work closely with the BD team to help secure business and be responsible for client communications and project presentations.
Desired Skills and Experience Main Responsibilities:
Provide formulation development and dosage form manufacturing expertise for the timely execution of development projects
Lead formulation development teams and work successfully in a cross functional team environment
Participate in Client meetings
Required Skills and Experience: Ph.D. or MS (with experience) in Chemistry, Biology, Pharmacy, Pharmaceutics, or related
discipline. Experience in the design, development, and manufacturing of oral dosage forms and/ or topical
dosage forms. Experience in experimental design and execution leading to achieving formulation goals. Experience in formulation feasibility development and translating that knowledge to manufacturing
processes. Experience with dosage form manufacturing in a GMP environment
Experience in generating and executing GMP batch records, and other required GMP documentation Extensive experience in one of the following areas: tablet and capsule formulations and
manufacturing, topical liquid and semi-solid dosage form development and manufacturing, solubilization technologies including amorphous dosage forms (HME and spray-dried dispersions), controlled release
dosage forms. Excellent written and oral communication skills Excellent collaboration skills, both with internal and external clients
FORMEX - The Formulation Experts
Formex is a leading contract development and manufacturing organization focusing on oral and topical dosage forms. Formex delivers novel and innovative solutions to challenging problems in pharmaceutical product
development and manufacturing. The company provides contract services for clients that vary from small virtual companies, to midsize biotech and pharma to the largest pharmaceutical organizations. Formex specializes in bioavailability enhancement and controlled release technologies, such as hot melt extrusion, spray drying, fluid bed processing, and liquid/semi-solid filled hard capsules. Our extensive
bioavailability enhancement technologies combined with our drug delivery expertise enables us to overcome many of the most difficult solubility challenges. From solid dispersions to controlled release, Formex creates customized solutions to meet each molecule’s
specific needs that help our clients reach their development targets on time with clear communication and industry leading quality. Products are made under Formex Quality Assurance supervision utilizing the highest quality standards in accordance with FDA and other regulations. Specialties: Formulation, Bioavailibility/Solubilization Enhancement, Product Development and Optimization, Cytotoxic Handling, Potent Compounds, Controlled Substances, Analytical Services, Stability Studies, Commercial Manufacturing, cGMP Manufacturing ********************************************************************************* Newest Jobs at JGB BioPharma Consulting- Week of 4/28/14 To apply for a position send your resume to [email protected] Quality Equipment/ Metrology Contractor – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) Z134FK DESCRIPTION:
The scope of work will include any remedial actions that may be required to bring existing QC equipment and controlling equipment up to satisfactory state of GMP compliance to support successful FDA PAI.
QP inspection of the QC lab in support of CTM release activities for a phase I EU clinical program.
Evaluate existing SOPs, forms, files, and practices against the existing gap analyses and GMP requirements to confirm compliance issues.
Write/rewrite and/or review SOPs and official forms to create a GMP compliant QC equipment system that will be sustainable for long term use by the QC department
Review, create/recreate, and repair equipment files for each piece of GMP equipment. This may require retrieval of information and documents from vendors and service providers
Ensure signage/labeling for each piece of GMP equipment is consistent and compliant with the equipment system and GMP requirements
Develop, or recommend purchase of, an improved software solution for scheduling PM/Cal/Qual events
Train personnel to operate and maintain the equipment system that results from the remedial actions
EXPERIENCE AND QUALIFICATIONS: 5+ years of prior experience working with GMP equipment systems and/or metrology programs in
the pharma, biotech, or medical device field Demonstrated experience with creating and maintaing equipment systems including writing SOPs,
creating official forms, and maintaining equipment files Strong attention to detail and a commitment to creating a high quality, user friendly, sustainable,
and equipment system
Quality Compliance Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JY131K DESCRIPTION: Summary:
Responsible for helping interpret cGMP regulations and current industry practices for operations. This includes internal audits, third party cGMP evaluations and approval, pre-approval inspections and all validation pro-grams. Oversees/manages facility/equipment utilization relative to compliance of current
manufacturing processes/procedures with current Good Manufacturing Practices, and other federal regulations, and company policies and procedures. Responsibilities:
Ensure that all activities associated with commercial product are performed according to the local Quality System and SOP’s.
Responsible for the overall GMP compliance for the facility, along with Reg CMC activities to ensure compliance with filed product.
Responsible for FDA and other HA compliance by making sure that quality systems are in place, and for keeping management updated on the same.
Direct the compliance programs for all cGMP areas including commercial product, including production, QA/QC, Engineering/Site Services and Pharmaceutical Technology/Contract Manufacturing Support at the sites. This includes internal / external audits (e.g. PAI, mock PAI, self audits, suppliers), Third Party cGMP evaluations and approval, Change Control management and all validation programs.
Responsible for products released and remaining on the market meet all specifications and regulatory requirements.
Interprets current Good Manufacturing Practices (cGMPs) for the sites and evaluates procedures relative to FDA / EU and industry standards. Recommends changes where appropriate.
Serves as resource person during inspections in Pharma Operations. Evaluates and/or recommends corrective actions with regard to FDA inspectional observations.
Where relevant, ensures a contract manufacturing program is in place for pre-approval inspection of third party facilities, batch release, complaint evaluation, investigations, equipment qualification and validation (e.g. process, cleaning, and packaging and computer validation).
Liaises with TRD to ensure internal and external audit program is in place covering pharma operations, as well as third party.
Monitor all PU Key Quality Indicators (KQI). Participate in site Quality Review Board.
Responsible for ensuring that sites are prepared for FDA / EU pre-approval inspections. Responsible for setting and achieving compliance yearly objectives, and adhering to budgets. Responsible that all individuals in compliance have appropriate education, experience, training, and
procedures to complete their responsibilities.
Responsible for ensuring compliance with Federal (FDA), State and local regulations. Ensure and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices
Responsible for liasing with the site validation master plan coordinator in order to en-sure all
commercial validation and qualification activities are addressed, and making sure the individual commercial Master Plans are in line with the Site master plan.
Provides final approval for Standard Operating Procedures, Production Training Documentation, Change Control, Validation Documentation for Production, Lab, IT (GMP systems), investigation and final batch release (as backup for QA).
EXPERIENCE AND QUALIFICATIONS: Working knowledge of local and global regulations and submission and approval processes for New
Chemical Entities (NCE) and product life cycle management.
Proven track record of successfully working in inter-disciplinary teams and of simultaneously planning, coordinating and leading activities on multiple projects or equivalent experience from external company or other line function.
Regularly demonstrated active contributions to line functions or project teams, e.g. change or site
transfer teams as well as ability to contribute to matrix teams with the necessary strategic thinking. Computer literacy in MS Project, PowerPoint, document management systems, databases and
ability to quickly learn new software, tracking tools and associated processes. Excellence in negotiation and communication skills as well as capability to influence others in a
matrix organization. Excellent organizational skills. Proactive and action-oriented attitude in driving projects. Ability to represent the site in cross functional teams.
A minimum of 10 years of related pharmaceutical experience. A minimum of 7 years experience working on a manufacturing site (e.g. QA, QC or production) or
laboratory or equivalent experience from external company or other line function preferable. A minimum of a Bachelor Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry,
Biotechnology, Biology) or equivalent.
Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is preferred.
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Senior Quality Control Analyst – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) ZD111M DESCRIPTION: Perform analytical testing of various drug substances, drug products and other materials according
to approved methodologies using HPLC, GC and other techniques. Responsible for following all appropriate SOPs, methods, policies and safety guidelines and training
of other QC analysts as requested. Prepare reagent, samples and equipment according to SOP and maintain instrumentation and lab
facilities. Responsible for completing and reviewing laboratory documentation in a cGMP compliant manner. Reports to the QC Laboratory Manager/Supervisor. EXPERIENCE AND QUALIFICATIONS: Must have good knowledge and experience with HPLC techniques, experience with dissolution
testing and good general chromatography knowledge. Must have good knowledge and understanding of GMP guidelines.
Must have good technical understanding of specific analytical techniques. Expected to work on special projects and other duties as assigned. Deliver quality products and services on time to all customers, internal and external. Provide employees with training and resources to meet or exceed customer requirements.
Monitor processes and products to identify opportunities for continuous improvement. BS in chemistry, biochemistry or related field or equivalent 4 years laboratory experience with chromatography analyses 2 years experience in the pharmaceutical or related filed with GMP experience
Quality Control Stability Senior Analyst/Specialist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) Y111CN DESCRIPTION:
Help set up stability studies for pharmaceutical products, evaluate stability data and draft stability reports under the direction of the Stability Manager.
Responsible for following all appropriate SOPs, methods, policies and safety guidelines and training of other QC analysts as requested.
Responsible for completing and reviewing laboratory documentation in a cGMP compliant manner and will also help review and approve laboratory data.
Reports to the QC Stability Manager. EXPERIENCE AND QUALIFICATIONS: Must have good knowledge and experience with general laboratory techniques, experience with
data review and good general chromatography knowledge. Must have good technical writing skills. Must have good knowledge and understanding of GMP guidelines. Must have good technical understanding of specific analytical techniques.
Expected to work on special projects and other duties as assigned. Deliver quality products and services on time to all customers, internal and external. Provide employees with training and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement.
BS in chemistry, biochemistry or related field or equivalent 4 to 6 years pharmaceutical laboratory experience 2 to 4 years experience drafting technical reports 2 to 3 years experience in the pharmaceutical or related field with GMP experience
Quality Control Specialist 1 – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) GR111P DESCRIPTION: Perform bioassay analytical testing of various biological drug substances, drug products and other
materials including cell-based bioassays, ELISAs and gel assays according to approval methodologies. Responsible for following all appropriate SOPs, methods, policies and safety guidelines and training
of other QC analysts as requested.
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Prepare reagents, samples and equipment according to SOP and maintain instrumentation and lab facilities.
Responsible for completing and reviewing laboratory documentation in a cGMP compliant manner. Reports to the QC Laboratory Manager/Supervisor. EXPERIENCE AND QUALIFICATIONS: Must have good knowledge and understanding of GMP guidelines. Must have good technical understanding of specific bioanalytical techniques. Expected to work on special projects and other duties as assigned. Deliver quality products and services on time to all customers, internal and external. Provide employees with training and resources to meet or exceed customer requirements. Monitor processes and products to identify opportunities for continuous improvement. BS in chemistry, biochemistry or related field or equivalent 6 years laboratory experience with 4 years in bioassay testing including cell-based bioassay
methods 4 years experience in the pharmaceutical or related filed with GMP experience
Senior Manager/Associate Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) K111DN DESCRIPTION:
Support the manufacture of Drug Substance and Drug Product at Contract Manufacturing Organizations (CMO) and Contract Research Organizations (CRO) to ensure products are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with Chemistry,
Manufacturing and Control (CMC) Team and functional areas. Responsibilities
Must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO.
Review Drug Substance/Drug Product master and executed batch records Review clinical packaging/labeling master and executed batch records
Manage CMO/CRO change control, deviation & CAPA systems Conduct supplier audits Maintain and improve quality systems QA review of test method validation/transfer QA review of equipment/instrument qualification
Represent QA in cross-functional projects Assume tasks in quality assurance area as required EXPERIENCE AND QUALIFICATIONS:
Must be familiarity with quality management of solid dosage forms (tablet, capsule) Experienced in conducting GMP audits Quality control and/or analytical development background helpful Small molecule synthesis and purification knowledge desirable
Working knowledge in CMC process Good interpersonal and writing skills Self motivated, independent, and collaborative Travel required (around 20%)
10+ years of quality assurance background in pharma/biotech industry, with hands-on role in quality operations and quality systems
3+ years hands-on QA experience in working with CMO/CRO B.S./M.S. in relevant science field
Senior Manager / Associate Director, Clinical Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111H DESCRIPTION:
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Support the Clinical Quality Assurance program. The incumbent will conduct and manage Good Clinical Practice (GCP) related quality audits (e.g., investigator site and vendor qualification); support development and improve the existing GCP related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff and hosting regulatory inspections. The position involves managing global clinical quality operations and liaison of clinical quality related issues with functional areas. Responsibilities: Must have the ability to execute CQA tasks independently; effectively represent QA in a GCP driven
team setting and interface with clinical vendors, investigator sites and regulatory agencies. Must actively participate in sustaining a level of inspection readiness of clinical stakeholders and act
as a catalyst for continuous process improvement. Develop GCP related quality system SOPs in compliance with all applicable regulatory requirements
and to align with existing company policy.
Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
Manage/conduct quality audits of investigator sites and various clinical vendors. Manage/conduct quality audits of clinical study documents, which include investigator brochures,
clinical protocols and clinical study reports, case report forms and informed consents forms. Manage/conduct internal audits to ensure stakeholder system compliance with existing policies and
procedures, and GCP requirements, standards and guidelines. Provide expert CQA advice to stakeholders (e.g., Clinical Operations, Data Management,
Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations. Support the administration of the company’s training program by conducting GCP training to
internal departments and externally, as applicable. Manage/conduct targeted training of investigators/site staff.
Report GCP related deficiencies to QA management as well as plans for corrective and/or preventive actions (CAPA).
Assist clinical study teams in the development of CAPAs. Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven
data to upper management.
Coordinate responses to regulatory agency inspections. EXPERIENCE AND QUALIFICATIONS: Current and strong working knowledge interpretation/implementation of United States Code of
Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an
advocate for regulatory compliance. Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical
reasoning skills. Ability to use expertise and skills to contribute to the development of company objectives and
principles, and to achieve goals in creative and effective ways Ability to deal with ambiguity, creative and pragmatic approach to problem solving Travel will be required between 30 to 50% of the time Auditor and/or GCP certifications a plus
10+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
5+ years hands-on CQA/GCP Compliance experience B.S./M.S. in relevant science field
Associate Director / Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) W111EC DESCRIPTION:
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The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional areas with focus on Oral solid dosage form products. The successful candidate must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO. Responsibilities Review Drug Substance/Drug Product master and executed batch records Review clinical packaging/labeling master and executed batch records Manage CMO/CRO change control, deviation & CAPA systems Conduct supplier audits Maintain and improve quality systems Test method validation/transfer Equipment/instrument qualification Represent QA in cross-functional projects Assume tasks in quality assurance area as required
EXPERIENCE AND QUALIFICATIONS: 10+ years of quality assurance background in pharma/biotech industry, with hands-on role in
quality operations and quality systems
3+ years hands-on QA experience in working with CMO/CRO B.S./M.S. in relevant science field Quality control and/or analytical development background helpful Small molecule synthesis and purification knowledge required
Understanding of oral dosage forms technology (tablet, capsule) required Working knowledge in CMC process a plus Good interpersonal and writing skills Self motivated, independent, and collaborative
Some travel may be required
Senior Scientist (Process Development) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) PH111X
DESCRIPTION: Reporting to the Department Senior Director, the successful incumbent will work on all process
chemistry aspects of new small molecule pharmaceuticals Designing, proving in the laboratory, developing, and optimizing GTI free synthetic organic
processes/procedures to prepare new small molecule drug substances
Timely internal preparation of appropriate quantity and quality small molecule drug substances, intermediates, reference materials, metabolites, impurities, and degradation products
Assisting in isolation and identification of impurities and modifying processes to control impurity levels
Assisting in oversight of CMO activities related to technology transfer, development, optimization, scale-up and manufacture of drug substance and related materials
As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and support of investigations and deviations
Reviewing, verifying and approving process documentation and batch records for cGMP drug substance manufacturing
Regularly reporting work status and preparing written reports on work performed Reviewing drug substance documentation and reports for technical accuracy in support of
regulatory filings Cooperatively working with personnel in other departments: Analytical Development, Formulation
EXPERIENCE AND QUALIFICATIONS: Able to design synthetic routes and complex procedures for defined compounds Analytical skills such as HPLC, GC, LC-MS, NMR, FTIR, DSC
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Experienced writing reports on synthetic processes Team player with ability to positively communicate with team members Knowledge and understanding of cGMP regulations and ICH guidance Knowledge and understanding of the CMO industry and sources of commercial chemicals Experience with chemical scale-up, manufacturing batch record preparation, technology transfers,
and knowledge of larger scale GMP chemical synthesis Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable Ability to manage multiple projects simultaneously and work independently under limited
supervision Proficiency with word-processing, spreadsheet, chemical drawing, statistical, and project
management software (i.e. MS Word, Excel, ChemDraw, JMP or Design Expert, MS Project) PhD in synthetic and/or mechanistic organic chemistry At least 8 years experience with 5+ years in chemical process development of small molecules and
in developing and optimizing chemical processes
Chemical Engineer – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) H111BC DESCRIPTION: Reporting to the Department Senior Director, the successful incumbent will focus on process
safety, scale up manufacturing and process validation associated with new small molecule pharmaceuticals
Working in multi-functional teams to develop scalable processes which supplies API for safety testing, clinical trials and formulation development.
Supporting API projects through all phases of development (Phase I to Process Validation including commercial manufacturing).
Assisting in oversight of CMO activities related to technology transfer, optimization, scale-up and manufacture of drug substance
Ensuring that CMO is managing material handing appropriately and that processes are run safely Providing significant support for process validation projects including criticality assessment,
writing/reviewing process validation documentation, and process validation execution. As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and
support of investigations and deviations Reviewing, verifying and approving process documentation and batch records for cGMP drug
substance manufacturing Regularly reporting work status and preparing written reports on work performed Reviewing drug substance documentation and reports for technical accuracy in support of
regulatory filings Cooperatively working with personnel in Chemical Development and with personnel from other
Skills focused on optimization of unit operations such as reactions, distillations, extractions, membrane separations, chromatography, crystallization, centrifugation, filtration, drying and milling.
A technical background in kinetics, thermodynamics, fluid mechanics, mass transfer and heat transfer.
Experience writing technical reports Analytical skills are desirable, such as HPLC, GC, NMR, microscopy, FTIR, DSC, and/or on-line
techniques Team player with ability to positively communicate with team members
A basic understanding of government regulation such as FDA cGMPs, ICH guidance EPA hazardous waste regulations, local and federal environmental regulations, and OSHA chemical hygiene plans.
Knowledge and understanding of the CMO industry and sources of commercial chemicals Experience with transfer, scale-up and process validation of chemical processes to commercial
facilities Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable Ability to analyze extensive data sets and communicate a summary of their analysis effectively
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Proficiency with word-processing, spreadsheet, chemical drawing, simulation/modeling, statistical, and project management software (i.e. MS Word, Excel, ChemDraw, Dynochem, Vismix, Aspen, CFD, JMP, Design Expert, MS Project).
PhD in Chemical Engineering At least 5+ years in chemical engineering associated with development of pharmaceutical small
molecules
Scientist / Senior Scientist, Analytical Development (Small Molecules) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111W DESCRIPTION: Develop methods for characterizing and release testing of small molecule drug substance and drug
product therapeutics. Develop methods, qualify, and validate methods and transfer methods to QC for QC testing. Provide analytical support to chemists performing process development activities. In addition to strong chromatography and mass spectrometry skills, experience with dissolution
testing, particle size measurements, NMR, FTIR, DSC, TGA, ICP, XRPD, and other analytical techniques are a plus.
Developing and optimizing HPLC methods to report impurities and assay of small molecule drug substances and drug products
Qualification and validation of methods and transfer of methods to QC
Working with contract laboratories Writing protocols and reports suitable for regulatory submissions EXPERIENCE AND QUALIFICATIONS:
Demonstrated expertise with HPLC methodologies is required. Experience with mass spectrometry is required. Experience and knowledge of method qualification and validation is necessary. Strong communication skills, verbal and written, and a team-oriented approach are required.
Will be organized, self-motivated, and able to work both independently and as part of a team. Excellent writing skills are required. BS or MS with a minimum of 6+ years of industry experience or equivalent, or a PhD with a
minimum of 2+ years of industry experience is required. Title will be dependent upon experience level.
Scientist / Senior Scientist, Analytical Development (Biologics) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G111RY DESCRIPTION:
Develop capillary electrophoresis methods for characterizing and release testing of a monoclonal antibody therapeutic.
Develop methods, qualify, and validate methods and transfer methods to QC for QC testing. Use CE methodologies to characterize micro-heterogeneities in the monoclonal antibody. Experience with HPLC, mass spectrometry, and other analytical techniques are a plus.
Developing and optimizing cIEF and CE-SDS methods Qualification and validation of CE methods and transfer of methods to QC Characterization of micro-heterogeneities by CE methodologies Writing protocols and reports suitable for regulatory submissions
EXPERIENCE AND QUALIFICATIONS: Demonstrated expertise with capillary electrophoresis methodologies (cIEF, CE-SDS, CZE) is
required. Experience and knowledge of method qualification and validation is necessary.
Experience with monoclonal antibodies is preferred. BS or MS with a minimum of 6+ years of industry experience or equivalent, or a PhD with a
minimum of 2+ years of industry experience is required. Title will be dependent upon experience level. Strong communication skills, verbal and written, and a team-oriented approach are required.
The successful candidate will be organized, self-motivated, and able to work both independently and as part of a team.
Excellent writing skills are required.
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Staff Accountant – Contract to FTE (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RP121G DESCRIPTION: Plan, schedule and direct the accounts payable and disbursement function in an automated and
high volume AP systems environment. Ensure all payments are in accordance with company policy and approved signature authority Ensure all PO invoices are processed and applied to PO correctly Evaluate and implement process improvements, including the identification and evaluation of
business requirements for new automation solutions Evaluate and strengthen the department's internal control procedures Document and update department policies and procedures Manage and report on days payable outstanding (DPO) Provide a high level of service to internal customers and vendors Process travel and expense reimbursement Perform positive pay, manual check and automated check runs and check match file functions
using check processing software. Oversee 1099 reporting
Prepare monthly journal entries for Prepaid amortizations, G&A accrual, & Legal accrual Manage fixed assets and depreciation Review open PO report for accrual Assist the Accounting Manager with external auditors during the quarterly and annual financial
statement audits and reviews EXPERIENCE AND QUALIFICATIONS: Related experience in a high volume accounts payable environment
Experience in a AP supervisory role is a preferred A/P systems experience; NetSuite experience is preferred Experience with automated Purchase Order systems preferred Good understanding of accounting and GAAP
Experience with spreadsheet (Vlookup & Pivot Table) and database software Good organizational skills and, able to create clear, concise, and well-formatted reports Proactive and able to manage change Excellent verbal and communication skills Able to meet deadlines and manage multiple priorities
Minimum 3-5 years experience in Accounts Payable and General Ledger functions Accounting degree is preferred
CMC Regulatory Manager / Sr. Manager / Associate Director – Full Time (San Francisco/Peninsula/South
Bay/East Bay/Marin Area) AW113F DESCRIPTION: Responsible for managing the CMC aspects of domestic and international regulatory affairs for commercial and clinical projects. The candidate will be responsible for researching and interpreting global CMC
regulations and guidances, and providing early guidance to Quality and Manufacturing team members. The candidate will also work closely with CMC teams, corporate partners, and contract manufacturing organizations to prepare complete and accurate regulatory submissions, and meet established timelines. Expertise with biologics is essential.
Responsible for proactively managing CMC aspects of one or more global commercial programs. Plan, manage, and oversee preparation and submission of global CMC submissions, including
marketing and clinical trial applications.
Provide responses to regulatory authority questions regarding product information or issues. Ensure that CMC content is complete, well-written, and meets all relevant requirements. Represent the RA CMC function on assigned cross-functional project teams. Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and
provide strategic regulatory guidance for optimal implementation of changes. Manage interactions with FDA or other regulatory authorities for assigned project. Develop excellent relationships with internal functional groups, contract manufacturing
organizations, and corporate partners.
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EXPERIENCE AND QUALIFICATIONS: Experience in filing marketing applications, supplements, variations for biologic products in the US
is required; global submission experience desired. Experience in assessing post-marketing changes Thorough understanding of relevant drug development regulations and guidelines. Outstanding interpersonal and communication (written and verbal) skills. Strong writing and editing skills for technical documentation. Proficient with computer and standard software programs. Previous supervisory experience a plus. At least 4-6 years of experience in Regulatory Affairs in the pharmaceutical or biotechnology
industry (preferably with exposure to both development and commercial phases of the product lifecycle).
Expertise with biologics is essential. BA/BS degree in life sciences minimum.
Advanced degree a plus. *****************************************************************
Apply on company website Market Planning and Strategic Insights, Oncology Gilead Sciences - Foster City, CA Posted 11 days ago
Job description The Market Planning and Strategic Insights (Marketing Sciences) individual participates actively in Gilead's commercial planning efforts by providing unbiased, objective, in-depth information about current and future markets, product performance, customers, and competitors. Additionally, he or she identifies
critical business issues and opportunities for growth, collaborates with Gilead stakeholder, and works to embed an external market point-of view into the strategic direction of the company. This position will support the near-term product launch of Idelalisib, a first in class PI3Kd inhibitor and the growing oncology franchise.
Core responsibilities for the Oncology, Market Planning and Strategic Insights (Marketing Sciences) Position will comprise the following: • Working with key stakeholders, plays a key role in development and execution of market research plan supporting Oncology product launch. Subsequent to launch, will play a key role in monitoring and
diagnosis of plan execution and specified metrics/indicators of launch success. • Builds strategic thought partnership with the Idelalisib brand teams by providing an objective commercial viewpoint based on in-depth understanding of brand and market. • Manages Oncology market research studies, including project objective, design, vendor selection and
oversight, monitoring of data collection, data analysis and interpretation. Develops relevant and compelling presentation of market research insights for key stakeholders, including brand leadership and senior management • Creates, validates and refines patient based forecasts and strategic assessments. Communicates
revenue information throughout the organization as appropriate. • Manages and analyzes competitive environment sales records, market penetration, market potential and future trends and makes recommendations based on findings. • Keeps abreast of key market events and works to understand potential impact.
• Working with Analytics & Forecasting counterparts, compiles and analyzes statistical data on past sales and trends to interpret market trends and, as appropriate, recommend corrective courses of action • Partners with brand marketing, managed care marketing, regulatory, finance, manufacturing, Commercial operations functions and others, to provide a holistic analytical viewpoint, supporting strategic decision making across functional areas in preparation for a product launch.
Desired Skills and Experience • Strong strategic thinker who understands the critical role of market research in commercial strategy development, particularly in support of product launch. In addition, the position requires the following capabilities:
• Strong data analytical, market research and interpretive skills • Strong interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines. Ability to represent the Marketing Sciences function on cross-functional teams. Includes first-line accountability for Marketing Sciences contributions and provision of information and recommendations. • Strong communication skills with an ability to efficiently and productively communicate both orally and in writing are required. Demonstrates persuasive written and verbal communication skills. Is effective in a variety of presentation settings. Is comfortable around, and influential with, higher management. • Strong command of a variety of analytical and market research techniques, Uses rigorous logic and methods to solve difficult problems with effective solutions. Can see hidden problems; looks beyond the obvious and doesn't stop at the first answers. Uses creativity and ingenuity to develop solutions to complex problems, formulates strategies and approaches that may fall outside historical norms. • Sought out as an analytical expert and, more importantly, as a strategic adviser. Grasps key issues quickly, understands the "big picture" and links market insights to larger issues. • In-depth experience designing and conducting quantitative and qualitative primary and secondary market research. The ability to meaningfully portray and effectively communicate complex quantitative
data in an easy-to-understand format is required. Must have in-depth knowledge and experience in a complex franchise-specific market. Proven experience with global Sales and Marketing organizations and experience with pharmaceutical data sources e.g., IMS, WKH and Ipsos (Synovate) Chart Audits are required.
• Good project management skills and the ability to meet tight deadlines in an environment of competing and changing priorities. Must have strong task management skills to include planning, prioritization, objective setting, and meeting management and plan execution. In-depth ability to use Microsoft Office and other planning software required.
• Can deal with ambiguity and act without having the total picture, is able to effectively pose questions in order to tease out information required for decision-making. Can handle risk and uncertainty. • Strong commitment to quality. Consistently and thoroughly reviews work for accuracy before sharing with a wider audience. Delivers final products that are well vetted and reliable.
• Ability to travel ~20-30% of time. Minimum Experience • 7+ years of relevant pharmaceutical industry experience, including 5+ years of market research and/or strategic analysis and planning experience
• Significant experience conducting quantitative and qualitative primary and secondary market research is required. Expertise in a broad range of qualitative and quantitative market research techniques, including appropriate application of data collection and analytic approaches. • Experience developing and using Excel-based models and conducting quantitative analysis is required.
• Previous experience in launching products, and exposure to pharmaceutical product development and brand marketing are preferred. Preferred Experience
• BA/BS degree required. MBA or other advanced degree that is relevant to position is desirable. • Experience in life sciences, healthcare, pharmaceutical and biotech industry strongly preferred **************************************************************
https://www.linkedin.com/jobs2/view/13354269?trk=job_view_browse_map Research Analyst - Healthcare Services Allianz Global Investors - San Francisco Bay Area
Posted 11 days ago Job description This position is responsible for conducting fundamental research, developing insight into future stock performance and issuing well-supported, accurate recommendations to the firm. Primary focus would be Healthcare Services stocks.
Efficiently and aggressively maintain knowledge, contacts and, ultimately, insight into industry
Identify and monitor the key issues that will drive each stock, seeking to maintain an edge, and synthesize your insights along with modeling and valuation work to develop stock recommendations,
Leverage Allianz Global Investors’ Grassroots market research arm and develop other non
conventional data sources and analytical methods to obtain non-consensus insights,
Provide timely and concise communications on your recommendations to Allianz Global Investors’ platform. Develop strong working relationships with PMs and become an effective advocate of your ideas,
Participate in a wide-range of regularly scheduled meetings to review industry sector
fundamentals and stock picks,
Maintain ongoing knowledge of departmental procedures and update procedures as necessary. Desired Skills and Experience
Education and/or Experience:
At least 3 years’ experience researching and recommending stocks within Healthcare
Services sector. Strong working knowledge of microeconomics, finance, and accounting,
Strong academic credentials, with MBA or CFA highly preferred,
Strong industry contacts and knowledge.
Other Skills & Abilities:
Proven ability to conduct detailed fundamental analysis and reputation for innovative thinking,
Proven stock-picking ability,
Long/short experience is a strong plus,
Exceptional business acumen and ability to develop peer-to-peer relationship with company senior management teams,
Ability to work well with others and build strong personal relationships,
Extremely hard-working, high integrity and ambitious,
Excellent written and verbal communication skills.
Market Research Analyst Medicines360 - San Francisco Bay Area Posted 11 days ago Job description
Summary: This role will support the access team by providing up-to-date secondary and primary analysis of the IUD market, contraceptive trends, patient/provider needs, sales projections, and reimbursement needs. This is an exciting opportunity for a data-savvy market researcher who wants to make a difference in women’s health. Additional responsibiltiies are as follows:
Perform quantitative and qualitative analysis to enable informed strategic initiatives and market success; work will include birth control trend analysis and reporting, competitive analysis of the other key contraceptive players, and modeling the complexities of healthcare reform as it relates to our target market and product uptake.
Support the promotion of Medicines360 public sector access interests in joint decision-making committees with Medicines360’s commercialization partner by providing analyses and primary and secondary data summaries of results
Analyze large datasets from different sources to identify trends, opportunities, threats and cause-effect relationships. Suggest strategic insights and potential actions for increasing the impact of our product
Create and maintain the detailed targeted list of clinics (& providers) for the purpose of: communicating to sites, market research and feedback from sites, forecast potential, training needs, sales etc.
Plan, design, and conduct simultaneous complex market research projects. Includes collecting primary data (surveys, feasibility testing, focus groups), analyzing and presenting results to various stakeholders (power point).
Develop metrics, monitor and report on our impact post product launch Support market research analytics for the private sector as part of joint efforts with commercial
partner. Offer the Meds360 perspective on data trends and evaluation of primary market research. Interface with market research counterpart within commercial partnership
Conduct secondary and primary market research to support Meds360 strategic evaluations, BD assessments and new products(pipeline or marketed)
Maintain the market research department database of secondary and primary research. Support development of company presentations with internal and external data. Be
Support building forecasts/assumptions for sales as well as production unit demand Desired Skills and Experience
1 to 5 years experience working in a pharmaceutical or biotech company market research department or other applicable market research/analytics capacity
Minimum of a Bachelor’s degree; MBA preferred A background in working with vendors in creation and execution of primary market research would
be a plus. Personal and professional commitment to Medicines360 mission
Attributes: Broad, working knowledge of commonly used pharmaceutical industry secondary databases, as
well as datasets used by government and nonprofit entities Demonstrated analytical skills—understands the advantages and limits of different analytical
approaches, studies and their findings. Seeks to understand reasons behind trends
Refined verbal and written communication skills; Ability to communicate analytical results to stakeholders with varying degrees of technical background. And ability to translate results into actionable next steps
Capable of prioritizing and handling multiple projects simultaneously; Prioritize research resources
to impact critical business issues and decisions. A reputation for effectively working with others; good interpersonal skills and positive attitude Self-driven, innovative, technical, resourceful and well-organized Exemplary personal and professional integrity
*************************************************************** Apply on company website. Posted by Elisabeth De Carolis, Recruiter, Talent Acquisition
Senior Analyst, Managed Markets Jazz Pharmaceuticals - Palo Alto, CA.
Posted 3 days ago Job description This position is responsible for completion of payer and reimbursement analytics and reporting in relation to the Health Systems support of all Business Units. This position will develop and produce regular reports and dashboards in support of key Health Systems initiatives, manage Jazz relationships with key Health
Systems data vendors, and complete ad-hoc analyses in support of the NAM, SAM, RM, and Managed Markets Marketing teams within Health Systems. This position will be the resident expert and consultant analytical resource for payer and reimbursement related data. Job Responsibilities and Requirements:
Develop and produce regular reports and executive dashboards of key metrics related to coverage and reimbursement for Jazz Senior Leadership.
Collaborate with National Accounts, Reimbursement and Managed Markets Marketing teams to identify opportunities and threats, measure the success of initiatives, and make strategic recommendations, including monitoring general and economic market access trends
Provide input into the development of metrics tied to measuring the performance of implemented strategies
Analyze/provide insights using data to answer various channel and payer related questions on an ad-hoc basis
Establish a baseline ROI framework/template for use by account management to ensure consistent approach contract proposals
Utilize longitudinal patient level data to identify trends in specific metrics such as co-pays, out of pocket costs, payer coverage, and prior authorization approvals
Collaborate with various brand sales analytics/commercial operations teams to ensure alignment of data, resources, and metrics
Work cross-functionally with key stakeholders (including commercial ops and IT) to ensure that
existing data sources (managed markets marketing, brand marketing, medical affairs, regulatory, analytics, commercial ops and field sales) are leveraged for use by Health Systems
Desired Skills and Experience Requirements:
Bachelor’s degree (MBA or finance/accounting experience preferred) Prior Health Systems, Managed Care, Market Access or Reimbursement Experience Vendor management experience preferred Demonstrated knowledge of reimbursement and managed markets, formulary development,
coverage and reimbursement issues , specialty distribution and compliance laws and regulations Knowledge of and experience with utilizing large patient and payer level data sets preferred Demonstrated comprehensive knowledge of analytical and techniques, business acumen as it
relates to informing contract opportunity decision-making, and report building
Strong Excel and Powerpoint skills. Experience using and querying online analytical tools (Tableau, Access, SQL, etc..) and database management skills preferred
Advanced skills in modeling, reporting and analysis. Excellent written and verbal communication skills with a strong attention to detail Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will
receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. *******************************************************
Apply on company website for all McKesson jobs that follow. Posted by Amanda Johnson,Senior Talent Acquisition… Manager, Strategic Programs McKesson - San Francisco, CA
Posted 1 day ago Job description Current Need
McKesson is seeking a Manager of Strategic Programs to be responsible for executing strategic programs associated with sourcing and virtual sequestering of products for select Generics National Accounts customers.
Position Description The Manager of Strategic Programs will help lead the on-going development of key technologies need to support this rapidly growing segment of business to ensure we meet the needs of our customer and drive differential value. Additionally the Manager of Strategic Programs will manage the compliance of
contractual commitments with all Retail National Account customers. The Manager of Strategic Programs will serve as a subject matter expert in the Generics National Accounts space ensuring that we are effectively managing inventory in a manner that supports McKesson’s financial
guidelines and business rules. This position will be expected to contribute to ongoing Generics National Accounts initiatives that drive McKesson’s financial performance. Key Responsibilities:
Support the daily management of strategic programs associated virtual sequestering, including demand planning, data analysis and reporting for Rite Aid
Partner with Generics National Accounts Program Team to compile, analyze and report on data to forecast trends and support program growth and Rite Aid requests
Coordinate strategic program management efforts with Generics Product, Analytics and Program teams for Rite Aid contractual requirements
Manage to contractual MFN requirements and develop mitigation plans as applicable for Rite Aid Analyze opportunities for McKesson to improve and innovate generics inventory management
strategies while managing to contractual obligations with respect to existing National Accounts customers
Utilize Excel, SAP and Access to perform quantitative and qualitative analysis, financial modeling and product forecasting
Understand the dynamics of the Generics National Accounts space in order to ensure current strategies are aligned with broader Generics team and company goals
Desired Skills and Experience
Minimum Requirements 5 years project management or related experience
Critical Skills
Excellent analytical capabilities, design models financial models and forecasting models Strong communication skills, verbal and written
Previous program or project or product experience, some experience. Exceptional Excel skills and spreadsheet analysis techniques required Demonstrated ability to work cross-functionally and exercise good judgment in a fast paced
decision-making environment is required Additional Knowledge & Skills
Experience working with SAP Inventory or Operations experience Working with Pharmaceuticals Detail oriented, superior organizational skills
Education 4 year degree or equivalent experience
____________________________________________________________________________________ Apply on Company website Posted by Amanda Johnson
Director, Strategic Business Development McKesson - San Francisco, CA Posted 1 day ago Job description
Current Need McKesson is currently seeking a Director, Strategic Business Development to oversee all generic sales, customized solutions, and other generic opportunities with the third largest generics purchaser in the retail segment.
This position will be responsible for the development of critical process, accountable for opportunity creation and issue resolution, and will work to ensure critical knowledge disseminated in order to drive profitable market share growth. Key Responsibilities:
Serve as the single point for our customers daily generic business needs Will be accountable for managing monthly and quarterly performance management and business
reviews Ensure proper compliance to customer supply agreements Lead issue resolution across business teams Manage customer specific product formulas Develop, maintain, and audit custom specific reporting for usefulness and accuracy Build, manage, and coach a high performing team Gather market intelligence and develop custom offerings that provide market differentiation Manage the compilation, analysis, and reporting of data to forecast trends, applying mathematical
models and statistical techniques, to support customer related activities
Report out on business performance and market share impact Attend regular meetings with designated customer leadership and solicit feedback regarding the
program, products, and issues that may arise Provide status updates to McKesson Leadership Team
Desired Skills and Experience
Minimum Requirements 8+ years of product management experience including 5+ years managerial experience
Critical Skills Ability to communicate clearly with Executive level leadership Strong financial acumen, specific with P&L Strategic Operational ability to build and manage high level customer/client relationships Strong analytical capabilities
Proficiency with Excel and PowerPoint Additional Knowledge & Skills
Sales or Sales Pricing experience, Former industry experience (Pharma experience)
Consulting background Education
MBA preferred in Marketing, Business or related field or equivalent experience ____________________________________________________________________________
Senior Financial Analyst McKesson - San Francisco Posted 1 day ago by Amanda Johnson Job description
Position Description The Senior Financial Analyst will perform contract administration, contract implementation, rebate validation, income recognition, financial analytics and supplier dispute resolution for Generics supplier income.
Key Responsibilities:
Perform the income recognition and income management for supplier rebate; Prepare financial reports and analysis for finance and business forecasting;
Customer facing skills communication skills Negotiation experience specially with Suppliers or Supplier disputes Collaborative and critical thinking skills Excel experience with VLookups , Pivot tables
Additional Knowledge & Skills
Ability to be proactive vs. reactive Strong business acumen Pharmaceutical experience/ industry knowledge
SAP Ability to multi-task and meet deadlines Minimum 5 years of related professional finance or business related experience
Education 4 year Bachelor’s Degree, Finance, Accounting, or related field __________________________________________________________________________________
Manager, Generics Pricing & Analytics McKesson - San Francisco, CA Posted 1 day ago Job description
Current Need McKesson is seeking a Manager, Generics Pricing and Analytics, to be responsible for understanding and maximizing the generic financial position with our Retail National Accounts customers.
Position Description The Manager, Generics Pricing and Analytics will work with the customers and McKesson teams to develop processes to track, analyze, and report on customer profitability and identify new expansion opportunities.
Key Responsibilities:
Develop customer pricing models to support expand McKesson footprint with Retail National Accounts
Analyze opportunities for McKesson to expand generic products, services, and pricing strategies while examining market channels and exploring innovative business opportunities
Manage the compilation, analysis, and reporting of data to forecast trends, applying mathematical models and statistical techniques, to support Retail National Accounts customer growth
Evaluate business performance and analyze impact to market share ensure McKesson ability to exceed customer net sales and net income targets
Lead key product launch and pricing initiatives across McKesson Retail National Accounts customers Analyze customer purchasing trends to provide clear internal guidance with product pricing Utilize Excel, SAS, and Access to performance quantitative and qualitative analysis, financial
modeling, and economic forecasting Desired Skills and Experience Minimum Requirements: 3+ years of product management experience
Critical Skills: Finance background with strong analytical and modeling skills Experience with financial statements and forecasting Strong communication skills and possess the ability to work with cross functional groups.
Project management and organizational skills Exceptional Excel skills (pulling reports, modeling, pivot tables) BA degree Accounting or Finance Additional Knowledge & Skills:
Pricing experience Pharmaceutical experience C-Suite experience Professional presentation skills
Education: Bachelor's Degree required in Finance, Accounting, or other related business field - MBA a plus ____________________________________________________________________________________ Senior Product Analyst, Strategic Accounts
McKesson - San Francisco, CA Posted 1 day ago Job description Current Need
McKesson is seeking a Senior Product Analyst for Strategic Accounts to perform data, inventory and financial analysis. This role is responsible for supporting cross-functional business teams in developing, implementing, and managing analytical & operational processes, including the creation of decision-making
& status reports, all of which are critical to support: 1) inventory management business solutions for strategic pharmacy customers; 2) special supply deals with manufacturers of generic pharmaceutical drugs; and 3) service level goals for McKesson’s proprietary generics source program.
Position Description This is a hybrid role: part analytical and part operational, part technical and part business, part buy-side (supplier-oriented) and part sell-side (customer-oriented). The ideal candidate is either an experienced
business professional with strong skills in data analysis, SQL, and report-writing, OR, a technical professional, who has interest in immersing himself/herself in the generic pharmaceutical business and contributing directly toward operational & financial department goals. Key Responsibilities:
Data Analysis and Report Creation
Data pulls/analysis (ad hoc) to answer business questions, support supplier meetings, support customer meetings, supplement forecasting & buying system, and manage special product deals.
Create reports, alerts, and tools, in general, to automate and replace manual processes and data pulls (ad hoc), where needed, using SSRS (SQL Server Reporting Services)
Extract data from McKesson systems (eg, SAP, SQL, Sales History Database, etc) and analyze financial and inventory information. Organize extracted data into meaningful information using mainframe and PC based tools (eg, SQL, SAP, Excel, Tableau, and SSRS). Provide recommendations to enable timely and accurate decisions to be made regarding inventory levels, customer contractual commitments, special supply deals, and process improvement opportunities.
Inventory Management and Operational Support
Identify potential products appropriate for inventory programs, by attending regular service level meetings, reviewing weekly service level reports, and gathering intel from supplier community & Product Management team
Assist team in operational set-up, maintenance and communications regarding special supplier deals and customer-specific inventory. Includes responsibility for implementation and ongoing maintenance of inventory programs, often using ad hoc SQL queries where necessary. Includes adding products to inventory systems; determining, monitoring, and maintaining adjustments to forecasts,
purchase orders, and allocations; managing to system alerts that trigger execution of steps to manage inventory and purchase orders.
Financial Analysis
Measure, track, create and maintain both individual customer and departmental project scorecards on a regular basis. Includes working with individual team members from Program Management, Account Management, Product Management, Analytics, Pricing, DC Ops, Reverse Logistics, Sales & Marketing and Accounting to resolve scorecard questions and discrepancies.
Provide analytical support to determine business profitability and run ad hoc reports Desired Skills and Experience Minimum Requirements
8+ years accounting, finance, finance analytics or similar experience Critical Skills
Strong knowledge with SQL to perform data analysis. Creating reports to automate manual process and ad hoc data pulls, using ssrs. (or other reporting
tools) Strong written and verbal communication skills Customer facing skills Experience leading presentations at the executive level
Additional Knowledge & Skills Strong time management skills; ability to meet deliverables Self Starter Advanced Excel skills, pivot tables, V-lookups
Education 4 year college degree in related field ___________________________________________________________________________________
McKesson - San Francisco, CA Posted 3 days ago Job description Reporting to the Senior Director of Strategic Initiatives-Outside Services PMO, the Financial Analytics Manager, will be responsible for ensuring that McKesson is equipped with policies, procedures, processes &
systems, that mitigate risk and drive financial value, for internal clients seeking to source Professional Services labor. This position will help bridge the Procurement, VMO, BPG & various other internal/external stakeholders, in the McKesson Outside Services eco system, to achieve compliance & economic targets, through process development, strategic-tactical solutions & supporting completion of program milestones.
This position will work across the enterprise with a 1 McKesson framework and will be instrumental in enabling Business Units in attaining Professional Services efficiently. General duties, responsibilities & characteristics:
Plans, performs and implements process improvement initiatives Collaborates effectively with the OSPMO Project Manager in ensuring the Project Plan captures all
activities, deadlines, risks & issues, across various sub streams & teams Embedded with external consultants on a variety of Program activities/deliverables to drive quality
in an efficient and transparent manner, reporting progress to the Sr. Director & recommending solutions to issues
Diagrams and evaluates existing processes Organizes, leads and facilitates cross-functional project teams in a complex program Identifies root cause of problems & potential recommendations for course corrections Creates & Delivers analysis, summaries, reports & presentations on various process activities,
financial investigation or process & program items Surveys and analyzes best practices for techniques and processes Performs cost and benefit analyses; strong analytics skill set (hybrid process/financial)
Developing and producing program reporting/tracking documentation, including multiple work streams and projects across lines of business
Facilitating/Leading project meetings Offering constructive options to ensure projects track to original expectations and scope,
identifying resource and/or scheduling conflicts Functioning as escalation point to keep all parties aware of new and ongoing tasks Responsible for leading major projects including implementation of new features, internal process
improvements, new standards and procedures
Potential oversight of contractors and/or FTEs reporting to this position Excellent verbal and written communication skills to technical and non-technical audiences of
various levels in the organization (e.g., executive, management, individual contributors) Excellent analytical, decision-making, problem-solving, interpersonal, team-building, negotiation,
conflict management and time management skills Ability to persuade and influence others on the best approach to take Desired Skills and Experience Requirements:
5+ yrs in Project Management
Bachelor's degree in Finance, Economics and/or Business Administration or similar Critical Skills:
Experience working within a large, complex organization as a Sr Financial Analyst preferably within a PMO organization
Experience creating and presenting financial data to Executive team members, and the ability to discuss data in detail
Highly prefer PMO experience Ability to complete tasks, issues and items without direct supervision; self starter who can
participate in strategic planning sessions with the capability to implement strategy, tactically Strong cross functional experiences with the ability to communicate in both the written, spoken and
presentation forms
Additional Experience Desired: Experience working for publically traded Fortune 500 firms with a majority of the following characteristics:
Large Shared Services internal organizations/Federated management model Large distribution models in the supply chain
Federated management models seeking to evolve to centralized approaches Highly regulated industries with complex external stakeholder oversight Exposure to the Health Care/Biotech and/or Pharmaceuticals sector Multiple internal stakeholders across projects/tasks Previous PMO experience:
Supporting System Implementations from either a Business Process, Program or Financial role Analyzing and reporting on PMO status, issues and items Working with and for, various PMO Committees, consisting of several Vice President or above,
members
5/18/2014 66
Understanding of Audit/Risk & Process Remediation methodologies or demonstrated exposure to related activities
Experience working alongside, with and collaborating across, various external consultants to achieve Program goals
Corporate Finance experience Unit Based Budget Planning experience Experience working for and/or with Finance Shared Services organizations in large firms ************************************************************ Apply on company website. Posted by Director, Strategy & Business Development Omada Health - San Francisco Bay Area
Posted 11 days ago Job description We are looking for a professional to join our Strategy & Business Development team as a Director, reporting to the Chief Revenue Officer. This position will work closely with company leadership across
departments. Depending on experience and preference, the person in this role will likely split time between strategy projects (examples may include pricing, reimbursement, ex-US entry, and prioritization of new programs), and deal-focused business development work (channel partner deals, and/or program partner deals). The ideal candidate has previous experience in both domains, has worked in healthcare
before, is experienced in market analysis, and is an excellent communicator. We would like the successful applicant to start in this role during the months of May, June, or July 2014. RESPONSIBILITIES:
Business Development (channel partner strategy and deals; program partner strategy & deals) Strategy (analysis & strategy; near-term project focus on pricing, reimbursement, ex-US entry,
and prioritization of new programs) Desired Skills and Experience
Required:
MBA or graduate degree in a healthcare-related field Professional experience in healthcare 3+ years BD negotiations/contracting Strong presentation and group facilitation skills
Experience using Excel to structure market and/or operational/financial analyses Evidence of successful management (planning, oversight, etc.) of complex projects Experience analyzing and/or negotiating partnership agreements Preferred:
Experience with strategy formulation projects in healthcare Omada Health is a digital health startup focused on evidence-based digital health programs for serious diseases. Our first program helps people avoid type 2 diabetes by merging best-in-class design, online delivery, and smart devices with proven clinical guidelines.
We recently announced our Series B funding led by Andreessen Horowitz. (https://omadahealth.com/seriesbannounce/#omada-health-closes-23-million-series-b-financing-led-by-andreessen-horowitz)
*********************************************************** Apply on company website Director of Business Development- Generic's Impax Laboratories - San Francisco, Bay Area Posted 4 days ago
Job description Impax Laboratories is seeking a Director, Business Development, to support the VP Business Development in the identification, prospecting, evaluation, and negotiation of new Business Development opportunities, including product partnerships, strategic alliances, and mergers & acquisitions. This is an excellent
opportunity for someone who has a strong background in identification, analysis and presentation of new generic product opportunities. This critical role will help alert key stakeholders to new product opportunities, and will have a significant impact on the growth of our organization. If this sounds interesting to you, we want to hear from you. Desired Skills and Experience What we need you to bring to the table:
Bachelor’s degree in Business, Finance or related discipline required. MBA preferred. A minimum of seven (7) years of pharmaceutical industry experience with at least three (3) years
in the generics industry. A minimum of five (5) years of business development experience. Demonstrated ability to access new opportunities, assets or technologies and to drive the internal
processes to acquire the opportunities Highly skillful negotiator including negotiation strategy design Experience leading cross functional due diligence teams Strong knowledge of industry issues, alliances and deal trends
Excellent analytical skills with an attention to detail. Excellent leadership, interpersonal and influencing skills. Successful track record of working in a cross functional, matrix organization. Excellent verbal and written skills essential.
Excellent MS Office skills (especially Advanced Excel and PowerPoint). Ability and willingness to travel up to 30%, both domestic and international, required. We are an AA/EEO/Veterans/Disabled employer. Impax Laboratories, Inc. (Impax) is a technology based specialty pharmaceutical company applying its
formulation expertise and drug delivery technology to the development of controlled-release and specialty generics, and to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to
fully leverage its technology platform. Impax is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
Posted by Dana La Rosa, Director Human Resources at MDxHealth Product Development Scientist
MDxHealth - Orange County, California Area Posted 9 days ago Apply nowSave Job description
The Product Development Scientist is involved in planning, conducting and analyzing experiments leading to validation of diagnostic tests in the field of methylation-related oncology. The scientist works in a team and needs to communicate relevant information to professional colleagues and to participate constructively in decision making that will impact the performances of the final product. Responsible for
compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO, and state and federal requirements.
Responsible for the development and optimization of molecular assays in collaboration with others on assigned projects. Meets deadlines specified in overall project schedules.
Effectively drives new product development, design verification, scale-up, process optimization,
technology transfer to manufacturing and process validation activities. Participate in decision making regarding technical aspects of product development. Discuss and
evaluate the strategies necessary to meet product development objectives and requirements.
Elaborate detailed protocols to validate research hypothesis and confirm product compliance with predefine expected performances. Plans and executes simple and complex experiments independently.
Perform lab work according to internal quality standards, document accurately the results and archive them accordingly in order to facilitate downstream work (intellectual property, regulatory affairs or research follow-ups). Maintains strict laboratory notebooks and research records.
Analyze results using statistical methods, control for consistency with previous work, summarize and communicate main outcomes to team members
Participates in the evaluation and creation of new methods and procedures under the direction of the Director of Product Development.
Prepares technical reports, summaries, protocols and quantitative analyses that accurately and clearly communicate necessary information.
Drives creation of all necessary documentation to support product manufacture, including manufacturing specifications, QC test procedures, raw material specifications and validation protocols.
Applies professional concepts, in accordance with Company objectives to solve moderate to moderately complex problems in creative and effective ways.
Maintains high level of professional expertise through familiarity with scientific literature. May
participate in scientific conferences and contribute to scientific journals. Provides necessary training to Product Development team members and other personnel as
required. May be responsible for identifying patentable inventions.
Adapts to changes in processes, accepting approved changes and learning new tasks. Participates in continuing education programs. Performs other related duties as required or assigned. Desired Skills and Experience
Bachelor’s degree in life science or equivalent scientific discipline and at least 5-8 years related work experience, OR Master's degree in life science or equivalent scientific discipline and at least 3-5 years related work experience, OR Ph.D. degree in life science or equivalent scientific discipline and at least 1-3 years related work experience. (Advanced degree preferred).
Knowledgeable, with good technical insight of molecular biology, particularly PCR and MSP, DNA extraction and modification.
Continuously provides detailed and accurate work, high personal quality standards. Knowledge FDA quality systems regulations (QSR) and ISO standards (ISO 13485 or ISO 9001-
2008) a plus.
Language skills: Fluency in English with the ability to read, understand and write documents (e.g., SOPs, instructions, manuals, scientific publications, technical journals, reports, presentations, etc).
Mathematical and analytical skills. Reasoning ability, critical attitude and good communication skills.
Excellent team spirit. MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients.
Applying our patented DNA methylation platform and biomarkers, we help address a large and growing unmet medical need for better cancer diagnosis and treatment information. MDxHealth is a publicly-listed company trading on the NYSE Euronext (NYSE as in New York Stock
Exchange) markets of Brussels and Amsterdam under the ticker symbol "MDXH". MDxHealth was established in 2003 and is headquartered in Belgium. Its US headquarters is located in Irvine, CA.
MDxHealth develops molecular diagnostic products on its own or in partnership with pharmaceutical companies. Some of its products are already commercialized and the company has a broad pipeline of other products for major cancer indications.
Posted by Stephanie (Bruce) Moyer, Human Resources at Arbonne R&D Formulations Manager Arbonne International - Orange County, California Area Posted 9 days ago Job description We are currently seeing a R&D Formulations Manager that will supervise a formulations team responsible for new product development, provide leadership, creativity and technical support to the R&D formulators; coordinate projects and optimize project flow with in the lab Job Responsibilities Manage a team of formulators and a support group.
Interface with Sales, Marketing and Regulatory on formulation development. Work closely with formulators to develop formulation strategies and ensure project deadlines are
met.
Review lab submissions and documents to ensure all projects meet cost target, product performance, aesthetics and are regulatory compliant.
Provide technical support to formulators for product development and to resolve testing failures. Conduct research into new and innovative products through search of journals and trade
publications as well as meeting with vendors. Desired Skills and Experience Job Qualifications
B.S. in Chemistry or related science with at least 5 years of experience as a R&D Formulator for high-end or natural/organic skincare and hair care products.
3+ years of supervisory/management experience. Experience dealing directly with marketing and/or clients to develop products.
Experience supervising scale-up and manufacturing process. Comprehensive knowledge in all related testing for formulation and claim substantiation. Experience working in a cGMP environment and comprehensive knowledge of OTC regulations. Strong computer and communication skills.
Natural Products Group, LLC is the parent of Arbonne International, LLC and Levlad, LLC. Arbonne crafts premium personal skincare, beauty and wellness products for both inner and outer health using botanical ingredients and innovative scientific discovery. Levlad is a leading manufacturer and marketer of natural and organic personal care products for Arbonne and its own product brand, Nature’s Gate, as well as a
growing base of private label customers. Why work for Levlad? Because it doesn’t feel like work! Working for Levlad is a truly unique experience; there’s no other
company quite like it. Working with great people in a welcoming, exciting environment and that’s just the beginning. On a daily basis you’ll get the opportunity to learn a wide range of new things and to contribute your talents to a dynamic team of people. These are exciting times for Levlad and Arbonne. Our company is in the midst of extraordinary growth and we’re looking for the right people to become a part of it.
People like you! Arbonne Scientific Advisory Board Arbonne relies on a renowned group of medical experts providing insight, information and innovation.
Their goal is to extend our commitment to quality, scientific integrity and healthy lifestyles The Arbonne Scientific Advisory Board is comprised of leading professionals in science, medicine, health, wellness and nutrition.
Our Advisory Board supports the vision and voice of Arbonne by providing additional insight on the development, implementation and assessment of both products and informational content for our customers, company and community. The Advisory Board members lend their expertise and knowledge directly into the research and development process.
** TO APPL, please copy and paste the following link** https://external-levlad-arbonne.icims.com/jobs/1554/manager%2c-r%2bd-formulation/job ****************************************************** https://www.linkedin.com/jobs2/view/13509215?trk=eml-b2_group_digest-groupjobpost-job-0 Posted by Yvonne Verburgt, Senior Director Business… Director Formulation Development Formex - Orange County, California Area Posted 1 day ago Job description The Director of Formulation Development is responsible for leading formulation development projects for our clients. Activities will include developing prototype formulations and processes, defining and executing scientific plans , tabulating and evaluating process and analytical data and working with other scientists and team members. The director will have direct involvement in R&D and manufacturing activities. The
successful candidate will be a valuable group member and excellent group leader. The Director of Formulations will also be involved in discussions with potential clients, work closely with the BD team to help secure business and be responsible for client communications and project presentations. Desired Skills and Experience
Main Responsibilities: Provide formulation development and dosage form manufacturing expertise for the timely
execution of development projects Lead formulation development teams and work successfully in a cross functional team
environment Participate in Client meetings Required Skills and Experience:
Ph.D. or MS (with experience) in Chemistry, Biology, Pharmacy, Pharmaceutics, or related discipline.
Experience in the design, development, and manufacturing of oral dosage forms and/ or topical dosage forms.
Experience in experimental design and execution leading to achieving formulation goals.
Experience in formulation feasibility development and translating that knowledge to manufacturing processes.
Experience with dosage form manufacturing in a GMP environment Experience in generating and executing GMP batch records, and other required GMP documentation
Extensive experience in one of the following areas: tablet and capsule formulations and manufacturing, topical liquid and semi-solid dosage form development and manufacturing, solubilization technologies including amorphous dosage forms (HME and spray-dried dispersions), controlled release dosage forms.
Excellent written and oral communication skills Excellent collaboration skills, both with internal and external clients
FORMEX - The Formulation Experts Formex is a leading contract development and manufacturing organization focusing on oral and topical
dosage forms. Formex delivers novel and innovative solutions to challenging problems in pharmaceutical product development and manufacturing. The company provides contract services for clients that vary from small virtual companies, to midsize biotech and pharma to the largest pharmaceutical organizations.
Formex specializes in bioavailability enhancement and controlled release technologies, such as hot melt extrusion, spray drying, fluid bed processing, and liquid/semi-solid filled hard capsules. Our extensive bioavailability enhancement technologies combined with our drug delivery expertise enables us to
overcome many of the most difficult solubility challenges. From solid dispersions to controlled release, Formex creates customized solutions to meet each molecule’s specific needs that help our clients reach their development targets on time with clear communication and industry leading quality. Products are made under Formex Quality Assurance supervision utilizing the highest quality standards in accordance with FDA and other regulations. ****************************************************************************************************** Contact Chris Miclot for more information - 407-591-3021 – [email protected] Job #1223-MH2620 Job Title: Regional Sales Manager- Medical Capital - Salary Range: 100000 to 120000 USD Location: North East, NY
Click here to apply (mobile compatible) Regional Sales Manager | Medical Capital Equipment | Medical Device Northeast US
We are looking for top 10% Regional Sales Managers who are highly financially and internally motivated, with strong selling and sales management skills for a hybrid sales force of both direct sales reps and dealor/distributors. The manufactures capital equipment medical technology used in both MIS and open surgery in the area of
orthopedics, vascular and thoracic surgery and is looking for an aggressive Regional Sales Manager to drive business in a patient-centric environment. Experience managing a sales team selling su rgical capital equipment is required in one of the following areas: Image guided surgery, surgical robotics, energy/ablation devices, endoscopy, arthroscopy, medical power equipment / drills, surgical video –
visualization equipment, powered hand tools.
Position Requirements
MINIMUM 2+ years of documentable sales growth in medical sales management of capital equipment with an ASP of a minimum of $20,000.
Minimum 5 year selling medical capital equipment into the O.R. Must be highly financially and internally motivated, assertive and aggressive in driving sales growth
by hiring, training, mentoring and guiding your sales team. You must be comfortable with technology, be able to credibly present to C-Level executives using a
laptop computer, iPad, and be able to demonstrate proficiency with Microsoft Office applications (Word, Excel, Outlook and PowerPoint).
Flexibili ty and willingness to travel as needed – up to 50% (and occasionally more( to manage your sales reps.Since this position requires extensive driving during the workday, a valid driver's
license and satisfactory driving record is mandatory and background and drug testing (pre and post-employment) may be required.
Educational Requirements
Bachelor’s degree minimum from an accredited 4 year university MBA Preferred AT LEAST 5 years medical sales experience (required) RepTrax or other certification with ability to sell into the Operating Room
Date Posted: 4/17/14 Location: Oakland, CA Years Experience: 4 SENIOR REGULATORY AFFAIRS SPECIALIST - 13000006XJ Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people. Primary Function / Primary Goals / Objectives: Responsible for US, Canadian and other international regulatory activities, including filing and/or creation of Premarket Notifications, IDEs, PMAs, Technical Files, and country-specific product registration, as required. Works with Management of Regulatory Affairs to develop and implement strategies that will
ensure the timely introduction of product into the US, Canadian and other international markets. Coordinate and oversee preparation of well-organized, complete and scientifically sound regulatory submissions. Lead interactions and discussions with Regulatory Agencies to resolve issues arising during the regulatory submission review process to ensure a timely approval process. Major Responsibilities: Complete understanding of regulatory requirements, standards and guidance documents relevant to Abbott Diabetes Care business. General knowledge of other related disciplines. Prepare regulatory plans/strategies for new and modified products. Prepare US, Canadian and other international regulatory submissions. Provide thorough, practicable and creative solutions, consistent with organization objectives,
to a wide range of difficult problems. Works under general direction and independently develops approach to solve issues. Review product labeling, advertising and promotional materials as required for conformance with applicable regulations. Regulatory review of internal documents as CCB member. Additional Responsibilities: Prepare and update standard operating procedures for the RA department as required. Participate as a team member on product development teams. Provide guidance to RA Associate(s) in coordinating the preparation of regulatory submissions and reviewing technical documents. Participate as required in meetings, conferences with FDA. Prepare monthly reports of industry-wide regulatory actions such as device recalls, enforcement actions, and warning letters relevant to Abbott Diabetes Care business. Search monthly released 510(k) and PMA databases for product approvals for other blood glucose monitoring and related products.
Perform other related duties and assignments as required. Accountability / Scope:
Compliance with the applicable quality system requirements as defined by the training plan. Participate as a team member on international submission teams. Strong and timely communiction between US and International affiliates is required.
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
Minimum Education Required: Bachelor’s in a scientific or technical discipline or equivalent experience required. Equivalent experience is defined as minimum 4 years of regulatory affairs experince and a BS degree, or 2 years of regulatory affairs experience and a MS degree; in the medical devices industry.
Minimum Experience/Training Required:
Prepare and update standard operating procedures for the RA department as required. Participate as a team member on product development teams. Provide guidance to RA Associate(s) in coordinating the preparation of regulatory submissions and
reviewing technical documents. Participate as required in meetings, conferences with FDA. Search monthly released 510(k) and PMA databases for product approvals for other blood glucose monitoring and related products.
Perform other related duties and assignments as required. Experience with Class 2 and Class 3 medical devices.
IVD experience a plus. Manufacturing on-market support experience a plus. ************************************************************************************
Job Summary Date Posted: 4/17/14 Location: Santa Clara, CA Years Experience: 6 PROGRAM MANAGER HEOR - 1300000APD Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Primary Job Function Develop and communicate value messaging for Abbott Vascular products and therapies by providing health economic and reimbursement support for customers. This may include health economic studies,
health economic data analysis, reimbursement information and analysis (coverage, coding, and payment). Key internal customers may include new product planning teams, clinical science and operations, medical affairs marketing, sales and geography reimbursement teams. Key external customers may include provider customers (hospital economic buyers and physicians), private payers, government agencies,
physician societies and industry trade associations.
Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Provides analysis with no supervision to support cross-functional teams in development of health economic, value messaging, reimbursement and coverage strategies based on strong understanding of physicians, business/practice managers, payers, and their decision making systems. Works with minimal
supervision on cross-functional teams. Provides analysis with no supervision to support cross-functional teams in development of health economic, value messaging, reimbursement and coverage strategies based on strong understanding of
physicians, business/practice managers, payers, and their decision making systems. Works with minimal supervision on cross-functional teams. Develop and maintain key relationships with international reimbursement teams, providers, payers,
consultants and sales force as appropriate. Works with internal cross-functional teams to communicate the Abbott Vascular value proposition. Develop internal/external coding/coverage/reimbursement strategies, education, tools and support. Leads
the development and presentation of tools and trainings. Provides information on economic buyer and commercial payer-related issues related to reimbursement, coverage, and contracting for the Abbott Vascular product portfolio.
Develop and implement communication projects to keep internal Abbott Vascular management regularly informed about coding/coverage/reimbursement issues affecting the company and its customers. Manages projects with outside vendors. May manage project budgets.
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Working in conjunction with cross-functional teams to develop HEOR & Market Access Plans and strategies. Ensures timely and quality HEOR & Market Access deliverables (studies, publications, dossiers, government responses, sales and education tools) that support development of strong value propositions for Abbott Vascular products. Comments The expectation is that individuals in this position are leaders and mentors, but is not expected to have formal management responsibilities. Position Accountability / Scope
Working in conjunction with cross-functional teams to develop HEOR & Market Access Plans and strategies. Ensures timely and quality HEOR & Market Access deliverables (studies, publications, dossiers, government responses, sales and education tools) that support development of strong value propositions for Abbott Vascular products. Communicates with HEOR management and other departments necessary in
order to facilitate achievement of reimbursement and assess objectives. Participates in regular, internal platform meetings to influence and provide recommendations. Participates on key HEOR strategic cross-functional teams.
Minimum Education Bachelor's degree with 6 + years of experience or advanced degree (masters or PhD) or equivalent – seasoned and experienced. Functional experience in reimbursement or HEOR is highly desirable.
Demonstrates leadership and has potential to move to manager/director level. Minimum Experience / Training Required
Experience in medical device or pharmaceutical space. Experience in cardiovascular area desirable. Broad technical knowledge of health economics and outcomes research, including proficiency in design and executive of economic modeling studies used in dossiers supporting formulary inclusion, and pricing of
medical devices. Ability to manage without direction basic modeling and reimbursement analysis. Advanced Experience in Microsoft Office platform (Excel, PowerPoint, and Word) required. Experience with project management, database development or statistical analysis software desirable. Experience working with health plans, managed care and/or physician group payers preferred. Experience in gaining payer
coverage, coding and payment decisions and developing payer coverage policies preferred. Understanding of international health care systems and reimbursement desirable. Knowledge of clinical epidemiology and outcomes to help design study proposals, protocols, reports and publications. Design and conduct of systematic literature reviews. Retrospective and
prospective research experience. Ability to develop SOW and work with purchasing to establish POs. May manage project budget. Strong ability to make effective decisions independently while working in a matrix and off-site environment with minimal supervision. Decisive and quick thinker who is able to deal with abstract concepts and handle ambiguity well. Excellent communication skills required (written and
verbal). Must be able to communicate effectively to diverse audiences. Willing to travel up to 25%. ****************************************************************************************************************************************** Apply via
Job #1216-MH2620 Job Title: Business Development Region Manager - Wound Care - Asia Pacific Location: Asia Pacific, OU International Sales Manager, Wound Care, Asia Pacific Region, Business Development Japan, China, India, South Korea, Singapore Must live in Asia Pacific region, must be multilingual The successful candidate will lead expansion of the growing manufacturer of Wound Care and Surgical divisions into the Asia Pacific region in the identification, prioritization, negotiation, and relationship management of complex relationships with international companies and international distributors. You wil l represent the company’s entire portfolio of products including AWC, advanced wound care, wound dressings, biologics, burn therapy, fixation and closure devices, skin care and dermatology products. This is a customer-facing business development / sales position requiring significant travel and cultural agility and flexibility. Your experience should include managing relationships for the wound care division of companies such as 3M Healthcare, BSN, B.Braun, Beiersdorf, Covidien, Genzyme, Smith & Nephew, Coloplast, Convatec, Medela, Osiris, Human BioSciences, Baxter Biosurgery or one of the companies listed at the bottom of this
job description. Knowledge of the leading distributors and hospital /clinical providers of NPWT, AWC, moist wound care, ultrasound therapy for wound care, wound care medical devices, VAC, skin replacement biologics, and cell, collagen and hydrogel therapy is valued.
Position Requirements:
5++ years experience managing distributors and sales of medical devices in advanced wound care, biologics, regenerative medicine, and/or burn care in an international Asia Pacific capacity.
5++ years experience managing and working with international distributors with all partners in the region
5++ years experience working closely with distributors, end-users and professional organizations/societies in a collaborative approach to identify and pursue best channels for growth
of base business and introduction of new products/practices/concepts Excellent communication skills, with strong preference for candidates who are multilingual.
Position Responsibilities Ability to travel internationally extensively from your home base in Asia Pacific, at least three times
a month to the region you manage.
Actively support the VP in strategizing and analyzing the international market, as well as sales forecasting.
Manage and develop the distributor network, identifying new distributor leads, determining their viability and assisting the VP in selecting appropriate distributors.
Creating distributor reimbursement plans and supporting distributor education and training. Coordinating exhibitions in conferences, and representing the company at trade shows. Assisting with training and helping to promote the company’s full product line.
Prior experience (Direct or as Dealer / Distributor) with companies like the following would be beneficial:
Partners, WoundEl, Kalypto Medical, O2 Insights, Systagenix, Brennen Medical< BR> Previous Titles May Include: Regional Commercial Manager, General Sales Manager, Distributor Principal, Distributor Owner, Business Development Manager, Sales and Business Development Manager, Regional Sales Manager, Sales Services Director, Global Business Development, Business Unit Director, Market & Business Development Manager, Regional Sales Manager, Sales Manager, Manager, Asia Pacific; Sales
Executive Asia Pacific , Market Development, Asia Pacific NOTE: This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
5/18/2014 77
Legacy MedSearch ( www.LegacyMedSearch.com) is a boutique recruitment company exclusively serving the medical device and hea lthcare technology industry. With 25 years+ in the healthcare industry, our medical recruiting clinical expertise extends to most areas of surgery, surgical robotics, diagnostic & therapeutic imaging, surgical navigation and disruptive medical device technology. Our firm works with OEM and contract manufacturers of IMD, AIMD and Class I, Class II and Class III devices with special emphasis on endoscopic and minimally invasive surgery, surgical robotic technology, ablation and energy-based technologies such as wireless, RFID and sensor technologies that are in development for orthopedics, spine and spinal implants, neurosurgery, cardiology and cardiovascular and other emerging medical technology including PMA, 510(k) and IDE products. FUNCTIONAL AREAS OF EXPERTISE • C-Level and Executive Management • Research & Development • Sales & Business Development • Quality & Regulatory (QA/RA) • Clinical Affairs • Product Management
• Marketing, Clinical Marketing ENGINEERING EXPERTISE • Program, Project and Product Management • Human Factors
• Robotics • Embedded Software • Imaging • Systems Engineers
• Test & Reliability Engineer • Quality Engineering ***********************************************************************************************
Jobs That Crossed My Desk Through April 20, 2014 *********************************************************************************************
Oakland, CA Years Experience: 4 SENIOR REGULATORY AFFAIRS SPECIALIST - 13000006XJ
Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in
diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Primary Function / Primary Goals / Objectives: Responsible for US, Canadian and other international regulatory activities, including filing and/or creation of Premarket Notifications, IDEs, PMAs, Technical Files, and country-specific product registration, as
required. Works with Management of Regulatory Affairs to develop and implement strategies that will ensure the timely introduction of product into the US, Canadian and other international markets. Coordinate and oversee preparation of well-organized, complete and scientifically sound regulatory submissions. Lead interactions and discussions with Regulatory Agencies to resolve issues arising during the regulatory submission review process to ensure a timely approval process. Major Responsibilities: Complete understanding of regulatory requirements, standards and guidance documents relevant to Abbott Diabetes Care business. General knowledge of other related disciplines. Prepare regulatory plans/strategies for new and modified products. Prepare US, Canadian and other international regulatory submissions. Provide thorough, practicable and creative solutions, consistent with organization objectives, to a wide range of difficult problems. Works under general direction and independently develops approach to solve issues. Review product labeling, advertising and promotional materials as required for
conformance with applicable regulations. Regulatory review of internal documents as CCB member.
Additional Responsibilities: Prepare and update standard operating procedures for the RA department as required. Participate as a team member on product development teams. Provide guidance to RA Associate(s) in coordinating the preparation of regulatory submissions and
reviewing technical documents. Participate as required in meetings, conferences with FDA. Prepare monthly reports of industry-wide regulatory actions such as device recalls, enforcement actions, and warning letters relevant to Abbott Diabetes Care business.
Search monthly released 510(k) and PMA databases for product approvals for other blood glucose monitoring and related products. Perform other related duties and assignments as required. Accountability / Scope:
Compliance with the applicable quality system requirements as defined by the training plan. Participate as a team member on international submission teams. Strong and timely communiction between US and International affiliates is required.
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
Minimum Education Required: Bachelor’s in a scientific or technical discipline or equivalent experience required. Equivalent experience is
defined as minimum 4 years of regulatory affairs experince and a BS degree, or 2 years of regulatory affairs experience and a MS degree; in the medical devices industry.
Minimum Experience/Training Required: Prepare and update standard operating procedures for the RA department as required. Participate as a team member on product development teams.
Provide guidance to RA Associate(s) in coordinating the preparation of regulatory submissions and reviewing technical documents. Participate as required in meetings, conferences with FDA. Search monthly released 510(k) and PMA databases for product approvals for other blood glucose
5/18/2014 79
monitoring and related products. Perform other related duties and assignments as required. Experience with Class 2 and Class 3 medical devices. IVD experience a plus. Manufacturing on-market support experience a plus. *********************************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=9902CECE-C6CF-4DF8-8C1B-7171DF04020F&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary Date Posted: 4/17/14
Location: Santa Clara, CA Years Experience: 6
PROGRAM MANAGER HEOR - 1300000APD Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and
technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Primary Job Function Develop and communicate value messaging for Abbott Vascular products and therapies by providing health economic and reimbursement support for customers. This may include health economic studies, health economic data analysis, reimbursement information and analysis (coverage, coding, and payment).
Key internal customers may include new product planning teams, clinical science and operations, medical affairs marketing, sales and geography reimbursement teams. Key external customers may include provider customers (hospital economic buyers and physicians), private payers, government agencies, physician societies and industry trade associations.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Provides analysis with no supervision to support cross-functional teams in development of health economic, value messaging, reimbursement and coverage strategies based on strong understanding of physicians, business/practice managers, payers, and their decision making systems. Works with minimal
supervision on cross-functional teams. Provides analysis with no supervision to support cross-functional teams in development of health economic, value messaging, reimbursement and coverage strategies based on strong understanding of physicians, business/practice managers, payers, and their decision making systems. Works with minimal
supervision on cross-functional teams. Develop and maintain key relationships with international reimbursement teams, providers, payers, consultants and sales force as appropriate. Works with internal cross-functional teams to communicate
5/18/2014 80
the Abbott Vascular value proposition. Develop internal/external coding/coverage/reimbursement strategies, education, tools and support. Leads the development and presentation of tools and trainings. Provides information on economic buyer and commercial payer-related issues related to reimbursement, coverage, and contracting for the Abbott Vascular product portfolio. Develop and implement communication projects to keep internal Abbott Vascular management regularly informed about coding/coverage/reimbursement issues affecting the company and its customers. Manages projects with outside vendors. May manage project budgets. Working in conjunction with cross-functional teams to develop HEOR & Market Access Plans and strategies. Ensures timely and quality HEOR & Market Access deliverables (studies, publications, dossiers, government responses, sales and education tools) that support development of strong value propositions
for Abbott Vascular products. Comments
The expectation is that individuals in this position are leaders and mentors, but is not expected to have formal management responsibilities.
Position Accountability / Scope
Working in conjunction with cross-functional teams to develop HEOR & Market Access Plans and strategies. Ensures timely and quality HEOR & Market Access deliverables (studies, publications, dossiers, government responses, sales and education tools) that support development of strong value propositions for Abbott Vascular products. Communicates with HEOR management and other departments necessary in order to facilitate achievement of reimbursement and assess objectives. Participates in regular, internal
platform meetings to influence and provide recommendations. Participates on key HEOR strategic cross-functional teams. Minimum Education
Bachelor's degree with 6 + years of experience or advanced degree (masters or PhD) or equivalent – seasoned and experienced. Functional experience in reimbursement or HEOR is highly desirable. Demonstrates leadership and has potential to move to manager/director level.
Minimum Experience / Training Required
Experience in medical device or pharmaceutical space. Experience in cardiovascular area desirable. Broad technical knowledge of health economics and outcomes research, including proficiency in design and executive of economic modeling studies used in dossiers supporting formulary inclusion, and pricing of medical devices. Ability to manage without direction basic modeling and reimbursement analysis.
Advanced Experience in Microsoft Office platform (Excel, PowerPoint, and Word) required. Experience with project management, database development or statistical analysis software desirable. Experience working with health plans, managed care and/or physician group payers preferred. Experience in gaining payer coverage, coding and payment decisions and developing payer coverage policies preferred. Understanding of international health care systems and reimbursement desirable. Knowledge of clinical epidemiology and
outcomes to help design study proposals, protocols, reports and publications. Design and conduct of systematic literature reviews. Retrospective and prospective research experience. Ability to develop SOW and work with purchasing to establish POs. May manage project budget. Strong ability to make effective decisions independently while working in a
5/18/2014 81
matrix and off-site environment with minimal supervision. Decisive and quick thinker who is able to deal with abstract concepts and handle ambiguity well. Excellent communication skills required (written and verbal). Must be able to communicate effectively to diverse audiences. Willing to travel up to 25%. *********************************************************************************************** Access to job descriptions and search function at https://sjobs.brassring.com/TGWebHost/searchopenings.aspx?partnerid=13617&siteid=5316 Open positions at Novartis in San Carlos:
Assoc Dir, Program Management 141153BR Pharma - Global Development
Director, Quality Assurance TRD 136082BR Pharma - Global Development
Finance Manager BPA/FRA 134990BR Global Technical Operations
Head of Materials Handling AD 138905BR Global Technical Operations
HSE Manager 135201BR Global Technical Operations
Materials Specialist Receiving 138672BR Global Technical Operations
Process Expert 140374BR Global Technical Operations
Process Unit Engineer 111948BR Global Technical Operations
Product Steward 140170BR Global Technical Operations
PU Facilitator 124760BR Global Technical Operations
Sourcing and Materials Manager 138896BR Pharma - Global Development
Staff Project Engineer 137310BR Global Technical Operations
Territory Manager - San Francisco/San Mateo/Sunnyvale 130769BR Animal Health
************************************************************************* *********************************************************************** 32 Biotech and Pharma Recruiters at Source: http://www.genengnews.com/insight-and-intelligence/32-biotech-and-biopharma-recruiters/77900088/?page=1
************************************************************************ 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/
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 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: 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.
5/18/2014 84
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 [email protected], phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account).
Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search
resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml
I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my
favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************ 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” • [email protected] PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American
Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-
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 There’s website with jobs specific to medical device area at the www.legacymedsearch.com.
Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at [email protected].
You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. *************************************************************************
Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without
looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order:
1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-
salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location.
MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf *************************************************************************
Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in
the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on
careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her
indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business
executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my
suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at [email protected] if they wish to receive these mailings directly. *************************************************************************
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