Senior Medical Writer

Job overview

The Senior Medical Writer role is onsite in San Mateo, CA; compensation is not specified. The position supports BeOne Medicines’ clinical and regulatory documentation work. The writer prepares, edits, and formats clinical regulatory documents to meet submission standards, internal requirements, and project timelines. The role coordinates reviews and quality checks so documents are scientifically accurate, consistent, and ready for regulatory review.

What you'll do

• Write, edit, and format clinical study reports, protocols and amendments, investigator brochures, and clinical sections of regulatory submissions
• coordinate document review and approval cycles
• manage timelines and communicate milestones
• review documents authored internally and externally
• maintain medical writing processes, standards, templates, and style guides
• ensure documents follow company standards and regulatory guidelines
• coordinate contract medical writers as needed.

What we're looking for

Skills & competencies

senior medical writer

san mateo ca

beone medicines

medical writing

regulatory documents

clinical study reports

clinical protocols

investigator brochures

fda guidelines

ich guidelines

document quality

Work arrangement

• Weekend coverage required

Why this role

The posting requires a BA/BS degree and at least four years of relevant industry experience as a regulatory medical writer; a PhD or PharmD in life sciences is preferred.

About the employer

BeOne Medicines is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.