Remote QC Specialist: Regulatory Document QC

BeiGene Ltd.; United States; Remote; USD 75,000 - 100,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a QC Specialist to coordinate and complete QC reviews of clinical and regulatory documents, ensuring accuracy, consistency, and compliance with FDA/ICH guidelines.

The role supports document review, data verification, proofreading, and translation checks, with the ability to work remotely or from global offices. Key responsibilities include cross-referencing, fact-checking, and adherence to timelines while collaborating with Global Medical Writing and other teams.

Qualifications

• Clear, concise English communication skills, both written and verbal.
• Experience performing medical writing QC reviews of regulatory documents.
• Familiarity with FDA/ICH guidelines and drug/biologics development processes.

Responsibilities

• Coordinate QC reviews of clinical and regulatory documents.
• Perform cross-referencing, fact-checking, and data verification.
• Proofread for grammar, formatting, hyperlinks, and data sources.
• Ensure compliance with writing conventions and regulatory guidelines.
• Prioritize tasks and manage multiple QC reviews under tight timelines.
• Collaborate with Medical Writers and intradepartmental teams.

Skills

English communication

Medical writing QC

Quality checking

Education

BA/BS or higher; plus

Tools

Microsoft Word

Microsoft Outlook

Excel

PowerPoint

Adobe Acrobat

Job description

BeOne Medicines Ltd. is seeking a QC Specialist to coordinate and complete QC reviews of clinical and regulatory documents, ensuring accuracy, consistency, and compliance with FDA/ICH guidelines.

The role supports document review, data verification, proofreading, and translation checks, with the ability to work remotely or from global offices. Key responsibilities include cross-referencing, fact-checking, and adherence to timelines while collaborating with Global Medical Writing and other teams.