Medical Affairs Communications Manager

Role: Medical Writer responsible for developing regulatory documents (NDA, IND, CSRs), clinical summaries, protocols, IBs, and study-related materials, with a focus on psychiatric and neurological therapeutics. Responsibilities include editing, finalizing, and formatting documents for eCTD submissions, producing external publications and congress materials, engaging with KOLs, and responding to medical information requests. The role involves collaborating with cross-functional teams (Regulatory, Biometrics, Clinical Ops), leading review discussions, performing QC, and contributing to speaker programs and training. Qualifications: Doctoral degree (PhD, PharmD, MD), 2+ years in scientific medical writing within pharma or agency settings, with experience in psychiatry, neurology, schizophrenia, mood disorders, or MS preferred. Additional skills include strong communication, project management, and the ability to adapt within a dynamic environment. CMPP certification is a plus. The position requires onsite work at Vanda’s Washington, DC headquarters, with up to 10% travel, including some weekends. The role is suitable for candidates with a scientific/clinical background, particularly in psychiatry or neurology, and emphasizes cross-functional collaboration, regulatory document expertise, and medical communication skills.