Associate Director, Regulatory & Medical Writing

Nurix•Brisbane, CA

4d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus

Responsibilities

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