Director, Medical Writing

Role: Senior Medical Writer supporting clinical development programs at a biopharma focused on cardiovascular indications. Objectives: produce high-quality, scientifically robust clinical documents to facilitate program advancement and regulatory submissions. Responsibilities: lead authoring and review of clinical study reports, protocols, investigator's brochures, and summaries; translate complex clinical and statistical data into clear narratives; ensure document quality, consistency, and alignment across cross-functional teams; contribute to the evolution of the medical writing function’s strategy and process improvements. Requirements: degree in life sciences; 8+ years of medical/clinical writing experience in biopharma or CRO; expertise in authoring complex clinical documents independently; thorough knowledge of drug development, ICH, GCP, CTD/eCTD, and regulatory standards; strong communication and stakeholder management skills. High-Value: expertise in cardiovascular clinical development, experience with global regulatory submissions, familiarity with GxP, clinical trial phases, and cross-functional collaboration. Work setup: onsite in Lexington, MA, five days per week.