Senior Medical Writer: Regulatory & Study Documentation

BioMarin Pharmaceutical Inc.; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

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

You will draft protocols, clinical study reports, and safety documents, coordinate with cross-functional teams, and ensure standard templates and quality across programs. Strong writing, editing, and regulatory experience required.

Qualifications

• Experience writing, reviewing, or editing protocols and clinical study reports.
• Experience with INDs/BLA/NDAs, PBRERs, DSURs, and PAERs preferred.
• Regulatory writing experience for regulatory submissions and publications.

Responsibilities

• Drafts and edits protocols, clinical study reports, and safety documents for regulatory filings and publications.
• Manages document review, timelines, and comment adjudication with study teams.
• Represents Global Medical Writing in cross-functional meetings to align on documents.
• Builds partnerships with cross-functional groups to meet stakeholder needs.
• Provides peer review and editing support for regulatory documents and summaries.
• Ensures adherence to departmental procedures and industry standards.

Skills

Medical writing

Regulatory submissions

Protocols & CSRs

Cross-functional collaboration

Project management

Data interpretation

Education

Bachelor’s degree in life sciences

Tools

Word

Excel

PowerPoint

Veeva

SharePoint

LiveLink

Job description

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

You will draft protocols, clinical study reports, and safety documents, coordinate with cross-functional teams, and ensure standard templates and quality across programs. Strong writing, editing, and regulatory experience required.