Overview
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 across the cardiorenal therapeutic area.
Responsibilities
- 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
- 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
- Salary Range: $280,000-$335,000/year (USD)
- Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
Application details
This job opens for applications on 1/28/26. Applications for this job will be accepted for at least 30 days from the posting date.
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