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BeiGene
Emeryville, CA, United States
**General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator
Job Source: BeiGeneBeiGene
San Mateo, CA, United States
**General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator
Job Source: BeiGeneAnnexon
South San Francisco, CA, United States
Position Summary The Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical, and Quality organizations to author and drive development of key
Job Source: AnnexonMirum Pharmaceuticals
Foster City, CA, United States
Are you within a commutable distance to Foster City and willing to commit to a hybrid work schedule with being on site 2 days per week? * -- If you are not local to the Foster City area, are you willing to relocate? * Yes No I am local Are you currently authorized to work for any employer in the US without visa support? * -- By participating in
Job Source: Mirum PharmaceuticalsAnnexon, Inc.
Brisbane, CA, United States
Director / Senior Director, Medical Writing Work Location Corporate Headquarters (South San Francisco, CA) - Hybrid Position Summary The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative tea
Job Source: Annexon, Inc.Annexon
Brisbane, CA, United States
Director / Senior Director, Medical Writing Work Location Position Summary The Director / Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, C
Job Source: AnnexonMeet
Menlo Park, CA, United States
Director, Medical and Regulatory Writing *Hybrid Role - Menlo Park, CA*' Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Director of Medical/Regulatory Writing to join their t
Job Source: MeetCorcept Therapeutics
Menlo Park, CA, United States
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercor
Job Source: Corcept TherapeuticsSan Mateo, CA, United States
**General Description:**
**Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and clinical sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents. This person will be responsible for the management, planning and direction of a team of full-time employees and/or contractors, consisting of medical writers, document specialists, and/or QC Specialists to support the planning and development of fit-for-purpose, high quality strategic documents in the context of the clinical development plan for all assets within a therapeutic area.**
**Essential Functions of the job:**
**Works effectively with cross-functional groups ensure the production of high-quality, scientificallyaccurate documents to support the clinical development of assets across the therapeutic area of responsibility, and ensures consistency between related documents and among medical writers, translators, document specialists, and QC Specialists.**
**Works with other members of the MW LT to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.).**
**Ensure clinical regulatory documents adhere to BeiGene standards and regulatory guidelines.**
**May assist in projections of Medical Writing department budget and resource needs.**
**Manages internal staffing and performance management, including hiring, training, coaching and performance reviews.**
**Coordinates and manages contractors and outside vendors.**
**Qualifications:**
**BS Degree with 12 years of overall experience is required; MA/MS/MBA with 10 plus years of overall experience or a PhD/PharmD with 6 plus years of overall experienceand is preferred.**
**Demonstrated ability to communicate and write English clearly, concisely, and effectively.**
**Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and ensure the completion of high-quality documents according to tight timelines and shifting priorities/demands.**
**Independently motivated with good problem-solving ability.**
**Excellent interpersonal skills - must have an ability to work well with others in high-pressure situations; a team player.**
**Strong project management and leadership skills.**
**Experience in writing clinical protocols, protocol amendments, clinical study reports, and clinical sections of INDs, MAAs, BLAs, and NDAs.**
**The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents.**
**Working knowledge of drug/biologics development, clinical research, study design, biostatistics, and regulatory affairs (eg, FDA and ICH guidelines for various scientific documents) is required.**
**Supervisory Responsibilities:**
**Supervises and guides the development of direct reports as well as cross-matrix supervision of MWs assigned to support documents within the assigned therapeutic area.**
**Further, the position will manage the delivery of services by the departments external vendors.**
**Computer Skills:**
**Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint.**
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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Email Alert for Senior Director, Therapeutic Area Lead, Medical Writing jobs in San Mateo, CA, United States
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