Director, Medical Writing

Role: Director of Medical Writing responsible for advancing clinical and regulatory documentation within Genmab's oncology-focused pipeline. Objectives include authoring and overseeing clinical trial protocols, reports, regulatory submissions, and scientific publications, ensuring compliance with guidelines and standards. Responsibilities involve leading complex document creation, managing cross-functional teams, mentoring staff, and developing processes and policies for medical writing. The role includes overseeing vendor relationships and driving strategic initiatives within the department. Requirements: Bachelor's in science or related field; 12+ years in clinical/regulatory medical writing in biotech/pharma, with at least 10 years in regulatory writing and oncology experience; demonstrated leadership in authoring major regulatory documents (NDA, BLA, MAA), familiarity with GCP, drug development processes, and cross-team collaboration. Preferred qualifications include advanced degrees. HighValue: oncology, clinical and regulatory documentation, regulatory filings (NDA/BLA/MAA), GxP compliance, process development, vendor management. Work setup: flexible (office/remote), specific travel expectations not stated.