Remote Senior Regulatory Documentation Specialist

BeOne Medicines Ltd.; Austin (TX); Remote; USD 80,000 - 110,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices for regulatory submissions using Veeva Vault, ensuring compliance with FDA and ICH guidelines.

The role can be remote or based in BeOne’s offices, with cross-functional collaboration within Global Medical Writing to produce high-quality, compliant documents under tight timelines. You will manage collection timelines, perform quality checks, and support Medical Writers in SOP/WI updates, while developing your

Qualifications

• Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
• Familiarity with regulatory submission requirements (FDA and ICH) is essential.
• Experience coordinating documents and workflows within pharmaceutical/biotech environments.

Responsibilities

• Coordinate and collect appendices documents in Veeva Vault for regulatory submissions.
• Ensure compliance with FDA/ICH guidelines and Medical Writing conventions.
• Manage appendices collection timelines and communicate with Medical Writers and cross-functional departments.
• Operate within Veeva Vault to import/export, initiate and approve workflows.
• Perform quality checks and approvals of appendices documents.
• Assist Medical Writers with SOP/WI updates or author documents as part of the DS scope.
• Participate in trainings to expand knowledge of medical writing and drug development.

Skills

Clear English communication

Project management

Prioritization under tight timelines

Attention to detail

Team collaboration

Problem solving

Education

Masters degree

BA/BS + 2+ years pharma/biotech

PharmD/PhD/MS as a plus

Tools

Veeva Vault

Microsoft Word

Excel

Adobe Acrobat

SharePoint

Job description

BeOne Medicines Ltd. is seeking a Senior Document Specialist to oversee appendices for regulatory submissions using Veeva Vault, ensuring compliance with FDA and ICH guidelines.

The role can be remote or based in BeOne’s offices, with cross-functional collaboration within Global Medical Writing to produce high-quality, compliant documents under tight timelines. You will manage collection timelines, perform quality checks, and support Medical Writers in SOP/WI updates, while developing your