Senior Manager, Medical Writing

Neurocrine Biosciences

Sr. Manager, Medical Writing preparing clinical regulatory documents for neurobiopharmaceutical treatments.

Posted 5/17/2026full-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
Leading the writing activities for all regulatory documents for a project team
Identifying and managing contractors
Planning activities for New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs)
Building and managing the submission writing team
Authors and manages the authoring process for all clinical/regulatory documents
Leads and provides subject matter expertise to the core authoring team
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

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
MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above
PhD in a life sciences or related field preferred AND 4+ years of experience as noted above
Previous managerial / functional management experience also required
Excellent team player who can effectively navigate differing opinions and personalities
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
General understanding of statistics
Broad understanding of the medical writing processes, procedures, and systems

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

medical writingregulatory document preparationNew Drug Applications (NDA)Marketing Authorization Applications (MAA)authoring processesproject managementstatisticsdocument management systemselectronic review tools

Soft Skills

leadershipcommunicationcreativityteam playermentoringnavigating differing opinionsorganizational skills