Senior Regulatory & Medical Writing Lead

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

Job summary

Nurix Therapeutics is seeking an Associate Director of Regulatory & Medical Writing to independently lead authoring, review, and approval of critical regulatory documents across our pipeline. You will drive strategic messaging, ensure document consistency, and manage the authoring and approval process to meet timelines.

You will collaborate with cross-functional teams, oversee resources, and contribute to process improvements.

Qualifications

• 6 to 8+ years of Regulatory and/or Medical Writing experience in Clinical Development.
• Experience interpreting data/information for inclusion in regulatory documents.
• Exposure to ex-US submissions is a plus.
• Ability to lead cross-functional working groups and manage timelines.

Responsibilities

• Lead authoring, review, and approval of regulatory documents across our pipeline.
• Review and QC documents authored by others to ensure consistency and quality.
• Manage multiple deliverables with timeline discipline and resource planning.
• Represent Regulatory & Medical Writing on interdisciplinary teams and with external resources.

Skills

Regulatory writing leadership

Cross-functional collaboration

Strategic scientific messaging

Document QA/review

Project planning

Health authority submission lifecycle

Microsoft Word proficiency

Veeva RIM Suite

MS Project / Smartsheet

Tools

MS Project

Smartsheet

Veeva RIM Suite

Microsoft Word (custom templates)

Job description

Nurix Therapeutics is seeking an Associate Director of Regulatory & Medical Writing to independently lead authoring, review, and approval of critical regulatory documents across our pipeline. You will drive strategic messaging, ensure document consistency, and manage the authoring and approval process to meet timelines.

You will collaborate with cross-functional teams, oversee resources, and contribute to process improvements.