Sr. Director, Head of Regulatory & Medical Writing

About the Company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.

Responsibilities

• Ensure appropriate allocation of internal and external resources for all regulatory writing deliverables
• Hire and manage internal medical writers and external contractors
• Forecast and maintain the regulatory writing team budget
• Coordinate, author, and edit documents including clinical study protocols, CSRs, Investigator's Brochures, and IND submissions
• Lead the preparation of NDA, BLA, and MAA (e)CTD submissions
• Participate in document strategy sessions regarding messaging, flow, and logic
• Support global transparency and disclosure requirements
• Maintain and review standard processes and templates

Requirements

• BS with 15+ years or MS/Advanced degree (PhD, MD, PharmD, etc.) with 10+ years of experience
• Extensive oncology clinical research experience as a clinical or regulatory medical writer
• Prior experience leading a regulatory writing group
• Experience leading writing for major regulatory filings (NDA, BLA, MAA)
• Deep knowledge of GCP, ICH Guidelines, and US FDA regulations
• Proficiency in document management systems and medical writing software
• Ability to interpret and summarize complex tabular and graphical data

Preferred Qualifications

• Experience with Pediatric Investigational Plans (PIPs)