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San Francisco Bay Area
(Hybrid - candidates must be local to SF Bay Area)
A Bay Area biopharma focused on next-generation biologics is seeking a seasoned Medical Writer to take a lead role in drafting and managing clinical and regulatory documents. This position will ensure scientific accuracy and consistency across submissions, while also shaping department processes and mentoring junior writers.
Key Responsibilities
Lead development of high-impact regulatory and clinical documents (protocols, CSRs, NDAs, BLAs, MAAs).
Oversee document planning, timelines, and cross‑functional collaboration.
Drive process improvements, SOP creation, and departmental initiatives.
Mentor junior staff and contribute to broader medical writing strategy.
Qualifications
PhD in life sciences (preferred) with at least 10 years of medical/scientific writing experience.
Strong background in pharma; oncology/immunology experience highly desirable.
Proven track record with regulatory submissions and GCP compliance.
Expert knowledge of style guides, templates, and regulatory requirements.
Demonstrated ability to lead teams and communicate effectively.
Local to Bay Area and able to work on a hybrid schedule.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Writing/Editing
Industries
Biotechnology Research
Pharmaceutical Manufacturing
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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San Francisco Bay Area
(Hybrid - candidates must be local to SF Bay Area)
A Bay Area biopharma focused on next-generation biologics is seeking a seasoned Medical Writer to take a lead role in drafting and managing clinical and regulatory documents. This position will ensure scientific accuracy and consistency across submissions, while also shaping department processes and mentoring junior writers.
Key Responsibilities
Lead development of high-impact regulatory and clinical documents (protocols, CSRs, NDAs, BLAs, MAAs).
Oversee document planning, timelines, and cross‑functional collaboration.
Drive process improvements, SOP creation, and departmental initiatives.
Mentor junior staff and contribute to broader medical writing strategy.
Qualifications
PhD in life sciences (preferred) with at least 10 years of medical/scientific writing experience.
Strong background in pharma; oncology/immunology experience highly desirable.
Proven track record with regulatory submissions and GCP compliance.
Expert knowledge of style guides, templates, and regulatory requirements.
Demonstrated ability to lead teams and communicate effectively.
Local to Bay Area and able to work on a hybrid schedule.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Writing/Editing
Industries
Biotechnology Research
Pharmaceutical Manufacturing
San Francisco, CA $119,000.00-$133,000.00 22 hours ago
San Francisco, CA $52,900.00-$70,000.003 days ago
San Francisco, CA $80,000.00-$90,000.00 2 weeks ago
Oakland, CA $80,000.00-$110,000.00 1 week ago
San Francisco Bay Area $95,000.00-$120,000.00 22 hours ago
Milpitas, CA $105,000.00-$125,000.00 10 months ago
San Francisco, CA $70,000.00-$85,000.00 1 month ago
San Francisco, CA $120,000.00-$195,000.00 6 days ago
San Francisco, CA $150,000.00-$170,000.00 1 month ago
UX Writer and Content Designer, Google Identity Engagement Milpitas, CA $72,000.00-$100,000.00 4 weeks ago
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Entry‑Level Technical Writer – AI & Open Source San Mateo, CA $129,410.00-$149,810.00 23 hours ago
UX Writer and Content Designer, Google Identity Engagement Sunnyvale, CA $115,000.00-$166,000.00 1 week ago
San Francisco, CA $22.02-$38.02 2 days ago
Visual Storytelling Prompt Writer - Remote San Francisco, CA $30.00-$50.00 2 days ago
San Francisco, CA $20.00-$40.00 2 days ago
UX Writer and Content Designer, ACI, Cloud Sunnyvale, CA $115,000.00-$166,000.00 1 week ago
San Francisco, CA $100,000.00-$130,000.00 1 month ago
Content Writer, Customer Experience and Adoption San Francisco, CA $83,100.00-$177,800.00 5 days ago
Senior, Copywriting (SF - Remote, Hybrid) San Francisco, CA $74,300.00-$100,500.00 4 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr