Associate Director, Regulatory & Medical Writing

The role

You will lead the authoring, review, and approval of critical regulatory documents across the pipeline. This includes clinical protocols, study reports, and health authority submissions.

What you will do

• Author and manage authoring of Regulatory & Medical Writing documents with cross-functional collaborators
• Ensure content consistency within and across documents for particular assets
• Develop strategic messaging and data presentation in accordance with Nurix standards and health authority requirements
• Review, edit, and QC documents developed by other authors or medical writers
• Manage the author, review, and approval process for multiple deliverables
• Lead Regulatory & Medical Writing activities for assigned programs
• Partner with the Head of Regulatory & Medical Writing on resource planning, timelines, and process improvement
• Represent Regulatory & Medical Writing on interdisciplinary teams
• Manage external Regulatory & Medical Writing resources as needed

Required qualifications

• 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase
• 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
• Ability to work effectively and lead in cross-functional working groups
• Excellent communication skills, organizational skills, and attention to detail
• Adaptable and flexible
• 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

Nice to have

• Involvement with ex-US submissions for clinical trial applications and marketing applications

About the company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. The company aims to establish degrader-based treatments at the forefront of patient care.