Senior Medical Writer - Regulatory Submissions (Remote)

BeiGene, Ltd.; Northern (KY); Hybrid; USD 102,000 - 137,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Medical Writer to author, edit, and format regulatory documents for US and international submissions, including study reports, protocols, and INDs/NDAs.

Remote role in the US; you will collaborate with cross-functional teams, ensure adherence to BeOne standards, and manage timelines and contract writers as needed.

Typical background includes 4+ years regulatory writing, BA/BS in life sciences, and strong attention to detail, with PhD/PharmD preferred.

Qualifications

• Senior Medical Writer with at least 4 years of regulatory medical writing experience.
• BA/BS in life sciences required; PhD/PharmD preferred.
• Experience drafting clinical study reports, protocols, and regulatory submissions.

Responsibilities

• Prepare and edit regulatory documents (CSRs, protocols, amendments) to meet timelines.
• Ensure documents align with BeOne standards and regulatory guidelines.
• Coordinate with cross-functional teams and external writers to maintain quality.
• Review documents and supervise quality checks before approval.

Skills

Regulatory writing

Scientific writing

Project management

Team collaboration

Attention to detail

Education

BA/BS in life sciences

PhD/PharmD preferred

Tools

MS Word

Adobe Acrobat

Electronic document management systems

Outlook

Excel

PowerPoint

Job description

BeOne Medicines Ltd. is seeking a Senior Medical Writer to author, edit, and format regulatory documents for US and international submissions, including study reports, protocols, and INDs/NDAs.

Remote role in the US; you will collaborate with cross-functional teams, ensure adherence to BeOne standards, and manage timelines and contract writers as needed.

Typical background includes 4+ years regulatory writing, BA/BS in life sciences, and strong attention to detail, with PhD/PharmD preferred.