Regulatory Writer and/or Regulatory QC/ Editor

Role Description

Vir Biotechnology is looking for a Regulatory Writer (Temporary) who will support the quality, consistency, and accuracy of regulatory documents produced by the Regulatory Writing team by either functioning as a support author and/or by focusing on editorial and QC review of documents written by other team members. Reporting to the Senior Director, Regulatory Writing, you will help ensure accuracy, compliance, and consistency of regulatory submission materials by partnering closely with medical writers, regulatory affairs, clinical, biostatistics, and other cross‑functional stakeholders.

What You'll Do

• In partnership with an experienced lead author, write and edit a wide range of regulatory documents, including but not limited to:
  • Clinical trial protocols and amendments
  • Investigator Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • Briefing packages
  • Components of regulatory submission dossiers (e.g., NDA, IND, MAA)
• Perform independent QC reviews of documents produced by the regulatory writing function.
• Verify the accuracy and internal/external consistency of documents versus their source materials.
• Define and confirm the scope of QC activities with document authors; identify required source documents/data and ensure availability prior to QC start.
• Review documents for adherence to applicable style guides (e.g., AMA Manual of Style and internal style/formatting standards), templates, and regulatory guidance; identify and document discrepancies and recommended corrections.
• Proofread and copyedit text to ensure clarity, grammar, spelling, punctuation, and consistency of messaging/presentation, while preserving scientific and regulatory accuracy.
• Support preparation and inspection‑readiness of technical documents for global regulatory submissions (e.g., eCTD/CTD), including integration of narrative text, tables, graphs, charts, and statistical output.
• Communicate QC findings clearly and constructively to medical writers and other stakeholders; collaborate to resolve issues and support timely completion of deliverables.
• Facilitate the efficient project management of individual document workflows (from KOM through handoff to publishing) and contribute to departmental trackers and integrated timelines. Communicate status and progress to stakeholders, participating in cross-functional meetings when needed.
• Contribute to the continuous improvement of QC tools, checklists, and processes; provide feedback on SOPs, work instructions, and best practices for regulatory document quality.

Qualifications

• Bachelor’s degree and 5 plus years of relevant experience. Advanced degree in science or medical field is a plus.
• Working knowledge of the industry and content of key eCTD documents, familiarity with CTD/eCTD structure and common templates.
• Understanding of drug development and regulatory submission processes, including familiarity with ICH guidelines and major health authority expectations (e.g., FDA, EMA).
• Exceptional attention to detail with strong analytical and critical‑thinking skills, including the ability to identify inconsistencies, data issues, and deviations from standards.
• Proven ability to manage multiple tasks and priorities in a deadline‑driven environment, operating with a high degree of independence and accountability.
• Experience working cross‑functionally in collaborative team environments and building effective working relationships with authors, reviewers, and project teams.
• Experience with electronic document management and publishing systems (e.g., Veeva Vault).
• Experience with project and timeline management systems (e.g., SmartSheet).

Benefits

• The expected hourly range for this position is $90.00 to $120.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.