Nurix Therapeutics
Sr. Director, Head of Regulatory & Medical Writing
Brisbane, California, United States · Director
Sponsorship not specified$254k-$289kDetected 3 days ago
GCPForecastingClinical TrialsClinical ResearchPatient CareFDA RegulatoryResearchLeadershipCommunicationPlain LanguageAdaptabilityGxPRegulatory Affairs
About the role
- Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.
Responsibilities
- Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
Requirements
- Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
- Ability to interpret and summarize complex tabular and graphical data presentations.
- Strong organization, documentation and communication skills with an ability to multitask.
- ability to meet day-to-day challenges with confidence and professionalism.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
- Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in 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).
- 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).
- Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities
Nice to have
- Experience with Pediatric Investigational Plans (PIPs) is preferred.
Compensation
- $254,127 - $289,388 plus bonus and equity.
- Investigator's brochures and annual updates
- IND submissions and annual reports
Benefits
- Hire and manage medical writers internally and manage external medical writing contractors.
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