Sr. Manager, Medical Writing
Neurocrine Biosciences
June 27, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading writing activities of an interdisciplinary team to develop concise, high-quality documents that comply with internal and external standards. Leads writing activities for all regulatory documents for a project team, including leading the writing process, identifying/managing contractors, planning NDA and global MAA activities, and building/managing the submission writing team.
Your Contributions (include, But Are Not Limited To)
- Authors and manages authoring of clinical/regulatory documents (e.g., clinical study protocols/reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, responses to regulatory questions, Pediatric Investigational Plans, and other regulatory documents)
- Leads and provides subject matter expertise to core authoring teams (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety/Pharmacovigilance, Preclinical, Regulatory)
- Leads data interpretation and comment resolution meetings
- Ensures documents are clear, concise, strategic, and positioned for public disclosure
- Supports authoring best practices and provides continued training
- Represents Medical Writing on project teams; mentors and may manage internal staff
- Represents Medical Writing on departmental projects and cross-functional teams
- Supports other lead writers on NDAs and MAAs
- Other duties as assigned
Requirements
- BS/BA in life sciences or related field AND 8+ years medical writing/related experience required (NDA/MAA leadership or key document authoring highly preferred); OR MS/MA preferred with 6+ years; OR PhD preferred with 4+ years
- Previous managerial/functional management experience required
- Proven ability to lead cross-functional teams through authoring process
- Leadership, communication, collaboration; strong project management (simultaneous projects)
- Excellent MS Word/PowerPoint, document management systems, and electronic review tools
- Ability to interpret/present clinical trial data and understand statistical analyses; general understanding of statistics
- Strong understanding of medical writing and regulatory process (streamlining content/processes)
Benefits/Compensation
- Annual base salary: $154,500.00–$211,000.00; annual bonus target 30% of earned base salary; eligibility for equity long-term incentive program
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Application Instructions
- No explicit application instructions provided.
Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading writing activities of an interdisciplinary team to develop concise, high-quality documents that comply with internal and external standards. Leads writing activities for all regulatory documents for a project team, including leading the writing process, identifying/managing contractors, planning NDA and global MAA activities, and building/managing the submission writing team.
Your Contributions (include, But Are Not Limited To)
- Authors and manages authoring of clinical/regulatory documents (e.g., clinical study protocols/reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, responses to regulatory questions, Pediatric Investigational Plans, and other regulatory documents)
- Leads and provides subject matter expertise to core authoring teams (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety/Pharmacovigilance, Preclinical, Regulatory)
- Leads data interpretation and comment resolution meetings
- Ensures documents are clear, concise, strategic, and positioned for public disclosure
- Supports authoring best practices and provides continued training
- Represents Medical Writing on project teams; mentors and may manage internal staff
- Represents Medical Writing on departmental projects and cross-functional teams
- Supports other lead writers on NDAs and MAAs
- Other duties as assigned
Requirements
- BS/BA in life sciences or related field AND 8+ years medical writing/related experience required (NDA/MAA leadership or key document authoring highly preferred); OR MS/MA preferred with 6+ years; OR PhD preferred with 4+ years
- Previous managerial/functional management experience required
- Proven ability to lead cross-functional teams through authoring process
- Leadership, communication, collaboration; strong project management (simultaneous projects)
- Excellent MS Word/PowerPoint, document management systems, and electronic review tools
- Ability to interpret/present clinical trial data and understand statistical analyses; general understanding of statistics
- Strong understanding of medical writing and regulatory process (streamlining content/processes)
Benefits/Compensation
- Annual base salary: $154,500.00–$211,000.00; annual bonus target 30% of earned base salary; eligibility for equity long-term incentive program
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Application Instructions
- No explicit application instructions provided.