Associate Director, Medical Writing

Role: Associate Director of Medical Writing leading multiple clinical regulatory documentation programs within a neuropharmaceutical setting. Responsibilities: independently plan, manage, and author complex documents supporting clinical development and regulatory submissions (e.g., protocols, study reports, NDA/BLA/IND documents); provide strategic guidance, oversee external contractors, and ensure alignment with regulatory requirements (ICH E6/E3). Collaborates with study teams and stakeholders to ensure consistent messaging and mitigates risks proactively. Supervises and mentors medical writing staff, drives department initiatives, and facilitates technology adoption. Requirements: Bachelor's in physical/life sciences with 8+ years (Master’s with 6+ years; PhD with 5+ years) relevant medical writing and project management experience, preferably in pharma or CRO; demonstrated regulatory writing expertise; strong leadership skills. High-Value: clinical regulatory documents, neuropharmaceutical focus, experience with IND/BLA submissions, Veeva Vault, ICH guidelines. Work setup: Not specified, but physical work indicates office-based environment; no travel specified.