Director, Medical Writing (Hybrid)

Role: Senior Medical Writing leader responsible for managing a team that develops clinical and regulatory documents for drug development programs. Objectives include authoring complex documents, advising development teams on content and presentation, and contributing to program strategies. Responsibilities encompass setting team goals, providing strategic input on clinical development and regulatory plans, optimizing cross-functional teamwork, managing resources, coaching staff, and leading process improvements. Requirements include a Bachelor's degree with a Ph.D. preferred, 10+ years of medical writing experience in pharma, biotech, or CRO industries, and 3+ years of supervisory experience. High-value specifics: expertise in clinical development, regulatory submissions, and marketing applications; strategic leadership in medical writing; experience with regulatory agencies and submission documents; familiarity with GxP standards. Collaboration involves cross-functional teams including clinical, regulatory, and development functions. Work setup is hybrid (2 remote days/week, 3 onsite in Boston Seaport), with relocation assistance available.