Remote QC Specialist – Medical Writing & Regulatory Docs

BeOne Medicines Ltd.; Emeryville (CA); Remote; USD 65,000 - 110,000; Full time

Job summary

BeOne Medicines is seeking a QC Specialist to coordinate and complete QC reviews of clinical and regulatory documents, ensuring accuracy and conformance to guidelines. Remote work options are available with potential global office collaboration.

The role emphasizes quality checks, fact-checking, and proofreading across study reports, protocols, and regulatory submissions, requiring strong English communication and attention to detail.

Qualifications

• Excellent English written and verbal communication.
• Experience performing QC reviews of regulatory documents (clinical study reports, protocols, amendments).
• Familiarity with FDA/ICH guidelines is preferred.

Responsibilities

• Coordinate and complete assigned QC reviews to ensure clinical and regulatory documents meet standards and timelines.
• Perform quality checks, cross-referencing, fact-checking, and data source verification.
• Proofread for grammar, formatting, hyperlinks, and data translation accuracy.

Skills

English communication

QC reviews

copyediting

fact-checking

cross-referencing

attention to detail

Education

BA/BS degree

Masters/PhD/PharmD a plus

Tools

Microsoft Word

Microsoft Outlook

Excel

PowerPoint

Adobe Acrobat

SharePoint

Veeva Vault

Job description

BeOne Medicines is seeking a QC Specialist to coordinate and complete QC reviews of clinical and regulatory documents, ensuring accuracy and conformance to guidelines. Remote work options are available with potential global office collaboration.

The role emphasizes quality checks, fact-checking, and proofreading across study reports, protocols, and regulatory submissions, requiring strong English communication and attention to detail.