Associate Director, Regulatory & Medical Writing

About the role

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.

Responsibilities

• 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 Regulatory & Medical Writing resources for assigned programs/projects, as needed

Requirements

• 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
• Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs

Skills

• Ability to work effectively and lead in cross‑functional working groups
• Excellent communication, organizational skills, and attention to detail
• Adaptable and flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day‑to‑day challenges with confidence and professionalism
• Knowledge of health authority requirements, ICH guidelines, and submission‑ready standards relevant to document authoring, including eCTD and submission lifecycle management
• Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and Veeva RIM Suite
• Expertise in Microsoft Word (including use of customized toolbars/templates) and document management systems

Pay

Salary Range: $216,400 - $234,800 (San Francisco Bay Area; actual offer depends on experience, expertise, and alignment with role requirements)