Senior Document Specialist

Job overview

The Senior Document Specialist is a remote-capable role that may also be performed from a BeOne global office; the listing location is Austin, TX. Compensation is not specified. The role supports the Global Medical Writing department’s regulatory submission documents for clinical study reports. The position coordinates and quality-checks appendices in Veeva Vault so submission materials meet applicable regulatory, scientific, and internal standards and project timelines. It helps Medical Writers and cross-functional teams manage document collection, workflows, and deliverables.

What you'll do

• Coordinate collection of appendices documents in Veeva Vault
• create binders of high-quality, scientifically accurate documents under ICH requirements
• ensure compliance with Medical Writing conventions and regulatory guidelines
• manage collection timelines and communicate milestones
• import and export documents, initiate and approve workflows, and work within Report Level Content Plans
• quality-check and approve appendices
• may assist with SOP or work-instruction updates or author documents within scope
• participate in relevant training.

What we're looking for

Skills & competencies

senior document specialist

medical writing

regulatory submissions

clinical study reports

veeva vault

document quality control

ich requirements

austin tx listing

beone medicines

remote or global office

appendices

occasional travel

Work arrangement

• Weekend coverage required

Why this role

Work may be performed remotely or from any of BeOne’s global offices; occasional travel may be needed.

About the employer

BeOne Medicines is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.