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 l 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, and Holidays
