Senior Regulatory Documentation Specialist (Remote)

BeOne Medicines USA; Texas; Hybrid; USD 90,000 - 130,000; Full time

Job summary

BeOne Medicines USA seeks a Senior Document Specialist to oversee appendices in Veeva Vault, ensuring regulatory submissions meet ICH and FDA requirements within tight timelines. The role involves coordinating with Medical Writers and other teams, performing quality checks, and supporting SOP updates.

The position can be remote or based in BeOne offices, with ongoing training in medical writing and drug development to strengthen expertise in regulatory science.

Qualifications

• Masters degree or BA/BS plus 2+ years of relevant industry experience; or 5+ years of on-the-job training in pharmaceutical/biotech.
• BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.
• Proven ability to manage projects, present to stakeholders, and lead meetings.

Responsibilities

• Create binders containing high-quality, scientifically accurate documents per ICH requirements under tight timelines.
• Ensure compliance with Medical Writing conventions, processes, and regulatory guidelines.
• Manage appendices collection timelines and coordinate with Medical Writers and cross-functional teams.
• Work in Veeva Vault to import/export, initiate and approve workflows, and perform related tasks.
• Perform quality check and approval of appendices documents.
• Assist Medical Writers with SOP or WI updates and author documents within the DS scope.
• Engage in trainings to increase knowledge of medical writing and drug development.

Skills

Project management

Regulatory knowledge

English proficiency

Multitasking

Teamwork

Education

Masters degree

BA/BS + 2+ years

5+ years pharma/biotech

Tools

Veeva Vault

Microsoft Word

Microsoft Excel

PowerPoint

Adobe Acrobat

SharePoint

Job description

BeOne Medicines USA seeks a Senior Document Specialist to oversee appendices in Veeva Vault, ensuring regulatory submissions meet ICH and FDA requirements within tight timelines. The role involves coordinating with Medical Writers and other teams, performing quality checks, and supporting SOP updates.

The position can be remote or based in BeOne offices, with ongoing training in medical writing and drug development to strengthen expertise in regulatory science.