Associate Director, Regulatory & Medical Writing

Associate Director, Regulatory Medical Writing Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients. Position Description The Opportunity Author and manage authoring of Regulatory Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as: Clinical study protocols and clinical protocol amendments Clinical study reports Investigator’s brochures and annual updates IND submissions and annual reports Lay-person summaries Integrated summary reports Clinical, nonclinical, and multidisciplinary information amendments NDA, BLA, MAA, and (e)CTD submissions Risk Management Plans Health authority responses Briefing documents, ODDs, BTDs/PRIME, FTD, and similar designations Review, edit, and QC documents developed by other authors or medical writers Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style Lead Regulatory Medical Writing activities for assigned programs, including partnering with the Head of Regulatory Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives Represent Regulatory Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates Manage external