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Corcept 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 TherapeuticsAnnexon
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 PharmaceuticalsCorcept Therapeutics
Menlo Park, CA, United States
The Associate Director, Medical Writing (Regulatory) will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Autho
Job Source: Corcept TherapeuticsCorcept Therapeutics
Menlo Park, CA, United States
The Senior Manager, Medical Writing will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Author, co-author, cri
Job Source: Corcept TherapeuticsBeiGene
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: 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: BeiGeneLion Heart Recruit LLC
San Leandro, CA, United States
Are you a dedicated and visionary medical professional ready to lead a dynamic clinic team and deliver life-changing patient care? Do you have the passion and expertise to drive clinical excellence and innovation in a collaborative healthcare setting? Position: Medical Director Location: San Leandro, CA Salary: $290k-$300k/yr (Full-Time/On-si
Job Source: Lion Heart Recruit LLCMenlo 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 team - this role will be reporting directly into the VP of Regulatory Affairs.
Key Responsibilities
You will lead the authoring of clinical/nonclinical documents (CSR, IB, DSUR)
You will manage the development of key regulatory submissions (IND/CTA/NDA/MAA)
You will work to author, edit, review, and process major submissions
Key Qualifications
8+ years of relevant industry experience required
Advanced degree (PhD, PharmD, MS) preferred
Experience leading the authoring of a variety of technical documents
Please reach out directly to Ryan Moran to learn more:
#J-18808-Ljbffr
Email Alert for Director, Medical Writing jobs in Menlo Park, CA, United States
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