Title: Executive Director - Medical Writing
Location: San Francisco United States
Job Description:
Piper Companies is seeking an Executive Director, Medical Writing to join an innovative organization within the biopharmaceutical industry for a hybrid permanent position based in San Francisco, CA. The Executive Director, Medical Writing will build and lead a medical writing function supporting multiple clinical development programs.
Responsibilities of the Executive Director, Medical Writing include:
Oversee, mentor, and develop the medical writing function to ensure effective performance and high‑quality deliverables.
Lead development of clinical and regulatory documents including protocols, CSRs, INDs, briefing documents, and submission components.
Provide strategic leadership to study teams to guide document planning, messaging, regulatory readiness, and public disclosure compliance.
Manage internal writers, external vendors, and document workflows to ensure timeline adherence, quality control, and alignment with regulatory standards.
Partner cross‑functionally with clinical, biostatistics, and data management to ensure accurate interpretation of data, consistent messaging, and submission‑ready outputs.
Qualifications for the Executive Director, Medical Writing include:
Post‑graduate scientific or medical degree (MS, MPH, PhD, PharmD, MD, DO) with 10+ years of regulatory medical writing experience in biotech/pharma.
Proven experience leading medical writing activities for major regulatory filings across multiple development stages.
Strong understanding of health authority regulations, ICH guidelines, data disclosure requirements, and medical writing standards.
Demonstrated ability to manage staff, oversee vendors, and influence cross‑functional teams in a fast‑paced environment.
Excellent communication, project management, critical thinking, and document planning skills with proficiency in tools such as EndNote, StartingPoint, and Veeva Vault (preferred).
Compensation for the Executive Director, Medical Writing:
Salary Range: $280,000-$335,000/year (USD)
Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
Keywords: medical writing, regulatory submissions, IND, NDA, MAA, clinical study reports, protocols, ICH guidelines, regulatory affairs, biostatistics, clinical development, data disclosure, document management, Veeva Vault, clinical trials, cardiorenal, rare disease, leadership, project management, biotech, biopharma.
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