Senior Medical Writer: Regulatory Docs & Cross-Functional

BioMarin Pharmaceutical Inc.; United States; Hybrid; USD 122,000 - 168,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a Senior Medical Writer to support development, drafting, review, editing, and finalization of documents used in clinical studies and regulatory submissions.

The role emphasizes advanced documentation skills, cross‑functional collaboration, and adherence to industry standards. Candidates should have extensive medical writing experience and a strong regulatory writing background.

Qualifications

• Bachelor’s degree in science; advanced degree desirable.
• 2+ years of progressive medical writing experience; regulatory focus preferred.
• Experience drafting and editing protocols, clinical study reports, and regulatory documents.

Responsibilities

• Drafts and edits documents for regulatory submissions and publications.
• Manages study team participation and timelines for document preparation.
• Represents Global Medical Writing in cross‑functional meetings and aligns with stakeholders.
• Adheres to internal procedures and industry standards across programs.

Skills

Medical writing

Regulatory writing

Cross-functional collaboration

Project management

Regulatory submissions

Education

Bachelor's or higher in life sciences

Tools

Veeva

LiveLink

MS Project

Word

Excel

PowerPoint

Job description

BioMarin Pharmaceutical Inc. is seeking a Senior Medical Writer to support development, drafting, review, editing, and finalization of documents used in clinical studies and regulatory submissions.

The role emphasizes advanced documentation skills, cross‑functional collaboration, and adherence to industry standards. Candidates should have extensive medical writing experience and a strong regulatory writing background.