RLH Talent is hiring: Sr. Director Medical Writing in San Francisco

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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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