Executive Director - Medical Writing job at reputed company in San Francisco, CA
Title: Executive Director - Medical Writing
Location: San Francisco reputed company
Job reputed company:
reputed company is seeking an Executive Director, Medical Writing to join an innovative organization reputed company the biopharmaceutical industry for a hybrid permanent position based in San Francisco, CA. The Executive Director, Medical Writing will build and reputed company a medical writing function supporting multiple clinical development programs.
Responsibilities of the Executive Director, Medical Writing include:
reputed company, mentor, and reputed company the medical writing function to ensure effective performance and high‑reputed company deliverables.
reputed company development of clinical and regulatory documents including protocols, CSRs, INDs, briefing documents, and submission components.
reputed company strategic leadership to study teams to guide document planning, messaging, regulatory readiness, and reputed company disclosure compliance.
Manage internal writers, external vendors, and document workflows to ensure reputed company adherence, reputed company 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‑reputed company 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/reputed company.
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, reputed company 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 reputed company Vault (preferred).
Compensation for the Executive Director, Medical Writing:
Salary reputed company: $280,000-$335,000/year (USD)
Comprehensive Benefits: Medical, Dental, reputed company, reputed company 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, reputed company Vault, reputed company, cardiorenal, rare disease, leadership, project management, biotech, biopharma.
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