Associate Director, Regulatory & Medical Writing
Nurix Therapeutics · Brisbane, CA
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Role summary
Nurix Therapeutics seeks an Associate Director to lead regulatory and medical writing functions for clinical development programs. The role involves authoring and overseeing submission documents to health authorities, managing cross-functional teams, and ensuring content quality and consistency across the pipeline.
What they're looking for
- 6-8+ years regulatory affairs, medical writing, or pharmaceutical/biotechnology clinical development experience
- Experience authoring clinical protocols, investigator's brochures, clinical study reports, and lay summaries
- Knowledge of ICH guidelines, health authority requirements, and eCTD submission standards
- Proficiency with MS Project, Smartsheet, Veeva RIM Suite, and Microsoft Word
- Strong cross-functional leadership and communication skills with attention to detail
- Experience with ex-US clinical trial and marketing applications preferred
What you'll be doing
- Author and oversee authoring of regulatory documents including IND submissions, NDAs, BLAs, and health authority responses
- Review, edit, and quality control documents from other authors; manage review and approval workflows
- Lead regulatory and medical writing activities for assigned programs and represent function on cross-functional teams
- Develop strategic messaging and data presentation aligned with company standards and regulatory requirements
- Manage external resources and collaborate with Head of Regulatory & Medical Writing on timelines and process improvements
Compensation$216,400 - $234,800
Privacy & handoff
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