Senior Medical Writer

Overview

As a Senior Medical Writer, you will lead the preparation and management of regulatory and publication documents for clinical studies. You will collaborate with cross-functional teams to ensure timely, compliant, high-quality manuscripts and submissions. The role supports the development science function, helping to reduce CRO costs and improve documentation consistency. You will help shape standard processes and templates to scale medical writing across programs. This hybrid role combines scientific writing, project management, and cross-team partnership to advance BioMarin’s mission.

Responsibilities

• Draft and edit clinical study documents (protocols, amendments, ICFs, CSR)
• Prepare regulatory filing documents (briefing books, eCTD modules)
• Summarize aggregate safety/efficacy data (IBs, PBRERs, DSURs)
• Lead study team participation in document prep, timelines, and review processes
• Represent Global Medical Writing in cross-functional meetings
• Partner with cross-functional groups to meet stakeholder needs
• Provide peer review and editing for regulatory documents (e.g., SAPs, CRFs)
• Develop and refine standard processes and templates within Global Medical Writing

Key requirements

• Bachelor
• Experience in medical writing
• Advanced knowledge of regulatory documents and eCTD processes
• Experience with protocols, CSR writing, and regulatory briefing books
• Proficiency in Microsoft Word, Excel, PowerPoint; familiarity with document management tools

• cross-functional collaboration
• excellent written and verbal communication
• detail oriented and organized
• Microsoft Word (templates and styles)
• Excel
• Adobe Acrobat

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