Senior Medical Writer - Regulatory Docs, Equity Eligible

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

Job summary

BeOne Medicines Ltd. is seeking a Senior Medical Writer to develop, edit, and format regulatory documents for domestic and international submissions, including study reports, protocols, and INDs/NDAs/MAAs. You will collaborate with cross-functional teams to ensure accuracy and timeliness.

The role requires strong English writing, rigorous attention to detail, and solid project management. You will manage contract writers, ensure adherence to BeOne standards, and contribute to developing writing

Qualifications

• 4+ years of regulatory medical writing experience.
• BA/BS in life sciences; PhD/PharmD preferred.
• Solid understanding of FDA/ICH guidelines for submissions.
• Ability to manage multiple documents and timelines.
• Excellent written and verbal communication in English.

Responsibilities

• Create, edit, and format clinical regulatory documents (studies, protocols, INDs, NDAs, MAAs).
• Ensure documents meet BeOne standards and regulatory guidelines.
• Coordinate with cross-functional teams and contract writers to meet timelines.
• Develop and maintain medical writing processes, templates, and SOPs.

Skills

Regulatory writing

English writing

Project management

Attention to detail

Team collaboration

Editing & proofreading

Communication skills

MS Word

SOPs familiarity

Education

BA/BS in life sciences

Tools

Adobe Acrobat

Electronic document mgmt systems

PowerPoint

Excel

Outlook

Job description

BeOne Medicines Ltd. is seeking a Senior Medical Writer to develop, edit, and format regulatory documents for domestic and international submissions, including study reports, protocols, and INDs/NDAs/MAAs. You will collaborate with cross-functional teams to ensure accuracy and timeliness.

The role requires strong English writing, rigorous attention to detail, and solid project management. You will manage contract writers, ensure adherence to BeOne standards, and contribute to developing writing