Strategic Regulatory & Medical Writing Lead

BioSpace; Brisbane (CA); On-site; USD 216,000 - 235,000; Full time

Job summary

Nurix Therapeutics is seeking an Associate Director, Regulatory & Medical Writing to independently lead authoring, review, and approval of regulatory documents across our pipeline—from clinical protocols to health authority submissions. This role partners with cross-functional teams to ensure strategic messaging and compliance with ICH and eCTD standards.

You will manage the authoring process for multiple deliverables, mentor writers, and oversee timelines and quality.

Qualifications

• 6 to 8+ years of Regulatory and/or Medical Writing experience in theClinical Development phase.
• Experience identifying and interpreting information/data for inclusion in documents such as protocols, IBs, CSRs, Lay Summaries, and ICFs.
• Involvement with ex-US submissions for clinical trial and marketing applications is a plus.
• Ability to work effectively and lead in cross-functional working groups.
• Knowledge of health authority requirements, ICH guidelines, and submission-ready standards for eCTD and lifecycle management.
• Proficiency in MS Project or Smartsheet, collaborative authoring tools, and Veeva RIM Suite.
• Expertise in Microsoft Word with advanced templates and document management systems.

Responsibilities

• Author and manage authoring of Regulatory & Medical Writing documents with cross-functional collaborators.
• Lead the authoring, review, and approval process for multiple deliverables with attention to consistency and style.
• Represent Regulatory & Medical Writing on interdisciplinary teams and provide strategic input.
• Manage external Regulatory & Medical Writing resources as needed.

Skills

Regulatory writing

Cross-functional leadership

ICH guidelines

eCTD submissions

Veeva RIM Suite

MS Project

Smartsheet

MS Word

Tools

Veeva RIM Suite

Document management systems

Job description

Nurix Therapeutics is seeking an Associate Director, Regulatory & Medical Writing to independently lead authoring, review, and approval of regulatory documents across our pipeline—from clinical protocols to health authority submissions. This role partners with cross-functional teams to ensure strategic messaging and compliance with ICH and eCTD standards.

You will manage the authoring process for multiple deliverables, mentor writers, and oversee timelines and quality.