Senior Medical Writer

Role: Senior Medical Writer responsible for authoring, editing, and formatting clinical regulatory documents to support drug development and regulatory submissions. Objectives include ensuring documents meet regulatory standards (FDA, ICH), are scientifically accurate, and adhere to company guidelines, while managing timelines and collaborating across functions. Responsibilities encompass producing high-quality study reports, protocols, investigator brochures, and sections of INDs, MAAs, and NDAs; coordinating with cross-functional teams; developing writing standards and tools; quality checks; and managing contract writers. Requirements include a minimum of 4 years’ relevant industry experience as a regulatory medical writer, a BA/BS degree (PhD or PharmD preferred), and strong skills in regulatory document writing, project management, and scientific analysis. Preferred skills involve experience with clinical study reports, regulatory submissions, and familiarity with drug/biologics development, clinical research, and GxP. High-value specifics involve biologics or small molecules, late-stage clinical (IND, NDA, MAA), and working knowledge of FDA and ICH guidelines. Reporting line or location details are not specified. The role emphasizes collaboration, attention to regulatory standards, and technical proficiency in Microsoft Office tools.