Associate Director Medical Writing

About the job Associate Director Medical Writing Role Overview We are seeking an Associate Director, Medical Writing to lead the development and execution of high-quality clinical and regulatory documentation. This individual will play a key role in shaping document strategy, managing the end‑to‑end writing process, and ensuring compliance with global regulatory standards. The ideal candidate brings a combination of strong scientific expertise, project leadership, and the ability to collaborate effectively across internal teams, external partners, and vendors. This role requires both hands‑on writing capabilities and the ability to guide complex, cross‑functional initiatives. Key Responsibilities Clinical & Regulatory Writing Leadership Serve as the lead medical writer across one or more clinical programs Author and oversee the development of key clinical and regulatory documents, including: Clinical study protocols and associated documents (e.g., informed consent forms) Clinical study reports (CSRs) Development Safety Update Reports (DSURs) Investigator's Brochures (IBs) IND summaries and overviews CTD Module 2 clinical summaries Partner closely with Clinical Science and cross‑functional teams to ensure alignment on document strategy and content Regulatory Collaboration Work alongside Regulatory Affairs to support preparation of submission materials such as: Health authority meeting requests and briefing documents Responses to regulatory inquiries Additional submission‑related documentation as needed Ensure all deliverables meet global regulatory standards and timelines Provide direction and oversight to external medical writing vendors Manage priorities, timelines, and quality expectations for outsourced work Act as a central point of coordination across internal and external stakeholders Process & Quality Improvement Contribute to the development and refinement of medical writing processes, templates, and style guidelines Partner with Quality Assurance to establish and update SOPs supporting medical writing activities Ensure compliance with ICH guidelines and other applicable regulatory frameworks Qualifications Advanced degree in a life sciences field (Master's required; PhD or PharmD preferred) 8+ years of medical or scientific writing experience within biotech, pharmaceutical, or CRO environments Deep familiarity with global regulatory requirements (e.g., ICH, FDA, EMA, Health Canada, APAC guidelines) Demonstrated experience authoring a broad range of clinical and regulatory documents Experience supporting Investigator‑Initiated Trials and collaborating with external investigators Proficiency with tools such as Microsoft Office, Adobe Acrobat, and document management/review platforms (e.g., SharePoint, Veeva RIM) Experience managing external vendors and/or contract writers Strong organizational skills and attention to detail Excellent written and verbal communication abilities Self‑starter with the ability to operate in a fast‑paced, evolving environment Comfortable working in a highly collaborative, hands‑on setting #J-18808-Ljbffr Enigma Search