Piper Companies is currently seeking an Executive Director of Medical Writing in Palo Alto, California.
The Executive Director will oversee the Cardiology medical writing activities across clinical development programs, regulatory submissions, public disclosure deliverables, and cross-functional document processes. The Executive Director ensures high-quality, compliant, scientifically sound documents that support clinical, regulatory, and corporate objectives.
Responsibilities for the Executive Director, Medical Writing:
• Oversee the Cardiology medical writing group, including leadership, training, mentoring, and performance management. • Lead medical writing from concept to final deliverable for clinical study protocols, protocol amendments, case report forms, clinical study reports (CSRs), investigator brochures, and related clinical documents. • Provide strategic leadership to study teams for preparation of protocols, CSRs, regulatory submissions, and public-disclosure deliverables. • Lead and coordinate medical writing activities for regulatory submissions including INDs, meeting requests, briefing documents, NDA/MAA modules, and full submission packages.
Qualifications for the Executive Director, Medical Writing:
Post-graduate scientific or medical degree (MS, MPH, PhD, PharmD, MD, DO). 12+ years of regulatory medical writing experience in biotechnology or pharmaceutical industries. Experience leading or contributing to multiple regulatory filings across various development stages. Excellent oral and written communication skills, with ability to synthesize, interpret, and present complex scientific and clinical data clearly and concisely.
Compensation for the Executive Director, Medical Writing:
Salary Range: $285,000-$345,000
Comprehensive Benefits: Medical, Dental, Vision 401K PTO Sick Leave as required by law Holidays