Sr. Director, Head of Regulatory & Medical Writing

Job Summary

The Sr. Director, Head of Regulatory & Medical Writing plays a crucial role in the cross-functional Development Team. They are responsible for regulatory writing expertise and leadership, guiding the writing strategy for key regulatory documents. They also oversee the review and editing of documents to ensure high-quality outputs.

Responsibilities

• Ensure appropriate allocation of internal and external resources for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecast and maintain budget for the regulatory writing team.
• Absorb efficiencies, help identify areas for improvement, and initiate improvement processes.
• Coordinate, author, and edit documents supporting clinical trial conduct and reporting, such as:
• Study protocols and amendments
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summaries
• Integrated summary reports
• Information amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc.
• Participate in relevant subteams and manage timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, EU posting regulations).
• Partner with Biometrics in developing standard TFLs and text tables for deliverables as applicable.
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications

• Candidates must have a BS with 15+ years of experience or MS/other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group.
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in computer software (word processing, graphics, reference manager, document management systems).
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures, and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation, and communication skills with an ability to multitask.
• Adaptable/flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines, and current US FDA regulations.

Salary Range

$254,127 - $289,388 plus bonus and equity.

About Nurix

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on discovering, developing, and commercializing targeted protein degradation medicines, aiming to improve treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine and ligase expertise, Nurix's team is dedicated to translating targeted protein degradation into clinical advancements.