Associate Director, Medical Writing

Role: Associate Director of Medical Writing leading clinical and regulatory documentation across development programs. Responsibilities: develop and execute document strategies, author and review complex clinical/regulatory submissions, oversee outsourced support, and collaborate with cross-functional teams including Clinical Development and Regulatory Affairs to ensure cohesive messaging and regulatory success. Requirements: PhD, PharmD, or equivalent; 8+ years in medical writing or related clinical research; experience with major regulatory filings (NDA/BLA/MAA, IND). HighValue: expertise in clinical document development, regulatory submission support, and cross-functional leadership within biopharma, preferably in neuroscience. WorkSetup: hybrid model based in Waltham, MA, with at least 3 days/week onsite.