Regulatory Medical Writer — Submissions & SOP Expert

BeiGene, Ltd.; United States; Remote; USD 102,000 - 137,000; Full time

Job summary

BeOne Medicines is seeking a Senior Medical Writer in the United States to join our fast-growing medical writing group. You will produce high-quality regulatory documents and ensure they meet BeOne standards under tight timelines.

You will edit others' work, develop processes, manage contract writers, and contribute to SOPs and templates while communicating clearly with cross-functional teams and regulatory stakeholders.

Qualifications

• 4+ years in regulatory medical writing with clinical study reports, protocols, or NDA sections.
• Strong ability to communicate clearly in English and write concisely.
• Experience coordinating reviews and managing timelines under regulatory deadlines.

Responsibilities

• Ensure assigned clinical documents pass quality checks before approval.
• Review and edit documents authored internally and externally.
• Coordinate timelines and communication across cross-functional teams.
• Develop and maintain medical writing processes, SOPs, and templates.
• Ensure documents adhere to FDA/ICH guidelines and BeOne standards.

Skills

Medical writing

Regulatory writing

English writing

Project management

Team collaboration

Editing

FDA/ICH knowledge

MS Word / Acrobat

Education

BA/BS in life sciences

PhD/PharmD preferred

Tools

Microsoft Word

Adobe Acrobat

Electronic Document Management Systems

Outlook

Excel

PowerPoint

Job description

BeOne Medicines is seeking a Senior Medical Writer in the United States to join our fast-growing medical writing group. You will produce high-quality regulatory documents and ensure they meet BeOne standards under tight timelines.

You will edit others' work, develop processes, manage contract writers, and contribute to SOPs and templates while communicating clearly with cross-functional teams and regulatory stakeholders.