Associate Director, Medical Writing

Role: Associate Director of Medical Writing overseeing clinical and regulatory documentation for CNS-focused pharmaceutical programs. Objectives: lead content development, ensure regulatory compliance, and support filings like NDA, BLA, IND, and CTA. Responsibilities: provide strategic input on document planning, serve as SME for document scope, guide study teams on data and regulatory requirements, review contractor submissions, and implement new tech initiatives. Qualifications: Bachelor's in science with 8+ years or Master’s with 6+ years of medical writing and project management; PhD preferred with 5+ years in pharma or CRO. Experience in clinical research, regulatory writing, and leadership in cross-functional teams is required. Skills: proficiency in Microsoft Office, Veeva Vault, medical terminology, and familiarity with ICH E6/E3 guidance. High-Value: expertise in CNS therapeutic areas, clinical development stage support, and regulatory submissions. Work setup: Sedentary role based in the U.S. with no specific travel requirements.