Associate Director, Medical & Regulatory Writing

Role: Associate Director of Medical & Regulatory Writing at a biopharma focused on cancer precision medicines, primarily overseeing clinical regulatory documents. Responsibilities: serve as SME in preparing protocols, study reports, Investigator’s Brochures, and briefing books; manage clinical trial transparency and disclosures, including vendor oversight; collaborate with cross-functional teams (regulatory, clinical, biostats, manufacturing) to ensure accurate study result reporting; lead development of transparency policies; oversee document review processes, timelines, and compliance with ICH-E3, GxP, and global regulations; track metrics, manage vendor relationships, and educate staff on disclosure standards. Requirements: Master’s or advanced degree in scientific/medical field (PhD preferred); 8-10+ years in regulatory/scientific writing within pharma/biotech/CRO, with CTD experience; proficiency in eCTD, Veeva or similar EDMS, MS Office, EndNote, Adobe Acrobat; strong knowledge of drug development, clinical research, and regulatory submission standards. Preferred: oncology experience, experience with clinical study reports, modules 2.5/2.7.3/2.7.4, vendor oversight, and familiarity with formatting tools. High-Value: focus on oncology, global regulatory compliance, clinical trial transparency, and cross-functional collaboration. Work setup: not specified; travel up to 10%.