Associate Director, Regulatory & Medical Writing

BioSpace; Brisbane (CA); In loco; USD 216.000 - 235.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory writing

Cross-functional leadership

ICH guidelines

eCTD submissions

Veeva RIM Suite

MS Project

Smartsheet

MS Word

Strumenti

Veeva RIM Suite

Document management systems

Descrizione del lavoro

Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline - from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients.

Position Description

The Opportunity

• Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as: Clinical study protocols and clinical protocol amendments
• Clinical study reports
• Investigator's brochures and annual updates
• IND submissions and annual reports
• Lay-person summaries
• Integrated summary reports
• Clinical, nonclinical, and multidisciplinary information amendments
• NDA, BLA, MAA, and (e)CTD submissions
• Risk Management Plans
• Health authority responses
• Briefing documents, ODDs, BTDs/PRIME, FTD, and similar designations
• Review, edit, and QC documents developed by other authors or medical writers
• Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style
• Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives
• Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates
• Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed

What You’ll Bring

• 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
• 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
• Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus
• Ability to work effectively and lead in cross-functional working groups
• Excellent communication skills, organizational skills, and attention to detail
• Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
• 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

Salary Range: $216,400 - $234,800

The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.

Location: Onsite - Brisbane, CA

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view

About Nurix Therapeutics

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. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.