Executive Director, Medical Writing - 158925

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.