Senior Medical Writer — Regulatory & Clinical Documentation Lead

BioSpace; Home (KS); Remote; USD 110,000 - 165,000; Full time

Job summary

BioMarin is seeking a Senior Medical Writer to author and edit regulatory documents and clinical study materials. You will work with cross-functional teams to ensure high-quality, compliant submissions across INDs, BLA/NDAs, and safety reports.

Responsibilities include coordinating study team reviews, developing timelines, and guiding document templates. A scientific background and strong communication skills are essential to align with regulatory expectations and project goals.

Qualifications

• Bachelor's degree required; scientific focus desirable.
• Experience in medical writing, including protocols and clinical study reports.
• Regulatory documentation experience (INDs/NDAs, PBRERs, DSURs) preferred.
• Ability to lead cross-functional teams and manage timelines.
• Strong written and verbal communication and presentation skills.

Responsibilities

• Draft, edit, and finalize clinical study reports and regulatory documents.
• Coordinate preparation with study teams and management of review cycles.
• Contribute to eCTD modules and briefing books as needed.
• Represent Global Medical Writing in cross-functional meetings.
• Develop and refine standard processes and templates within the writing group.

Skills

Medical writing

Regulatory writing

Project management

Communication

Cross-functional collaboration

Education

Bachelor's degree

Tools

Microsoft Word

Excel

Adobe Acrobat

MS Project/Project Server

PowerPoint

LiveLink

SharePoint

Veeva

Job description

BioMarin is seeking a Senior Medical Writer to author and edit regulatory documents and clinical study materials. You will work with cross-functional teams to ensure high-quality, compliant submissions across INDs, BLA/NDAs, and safety reports.

Responsibilities include coordinating study team reviews, developing timelines, and guiding document templates. A scientific background and strong communication skills are essential to align with regulatory expectations and project goals.