Senior Manager, Medical Writing

Neurocrine Biosciences

Sr. Manager, Medical Writing leading interdisciplinary team in regulatory document preparation at Neurocrine Biosciences.

Posted 5/7/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $154,500 - $211,000 per yearWebsite

About the role

Key responsibilities & impact

Prepares and reviews clinical/regulatory documents to support all phases of drug development
Leads the writing activities of an interdisciplinary team to develop documents that are concise, high quality, and comply with internal and external standards
Authors and manages the authoring process for all clinical/regulatory documents (e.g., clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, response to regulatory questions, Pediatric Investigational Plans, and other regulatory documents)
Leads and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Preclinical, and Regulatory) from a writing and scientific perspective
Leads data interpretation and comment resolution meetings
Ensures document content is clear, concise, strategic, and well positioned for public disclosure
Supports authoring best practices and provides continued training to teams
Represents Medical Writing Department on project teams
Mentor, 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

What you’ll need

BS/BA degree in the life sciences or related field AND 8+ years of medical writing or related experience required
Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred
OR MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above
OR PhD in a life sciences or related field preferred AND 4+ years of experience as noted above
Previous managerial/functional management experience also required
Proven ability to lead cross-functional teams through the authoring process
Strong skills in leadership, communication, and creativity
Excellent project management skills, including managing simultaneous projects
Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools
Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses
Strong science background that enables the ability to interpret and communicate scientific and clinical trial data
General understanding of statistics
Broad understanding of the medical writing processes, procedures, and systems used to accomplish the team’s work
Ability to provide strategic leadership as it relates to communicating and positioning nonclinical and clinical data.

Benefits

Comp & perks

Annual bonus with a target of 30% of earned base salary
Eligibility to participate in the equity-based long-term incentive program
Retirement savings plan (with company match)
Paid vacation, holiday, and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental, and vision coverage

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Hard Skills & Tools

medical writingclinical study protocolsclinical study reportsinvestigator brochuresregulatory documentsdata interpretationstatistical analysesproject managementauthoring processclinical trial data

Soft Skills

leadershipcommunicationcreativitymentoringteam collaborationstrategic thinkingproblem-solvingtrainingcross-functional leadershiporganizational skills