Regulatory Writer and/or Regulatory QC/ Editor
Vir Biotechnology, Inc.
June 25, 2026
Remote friendly (United States)
United States
Corporate Functions
THE OPPORTUNITY
Vir Biotechnology is looking for a Regulatory Writer (Temporary).
Responsibilities:
- In partnership with a lead author, write and edit regulatory documents including clinical trial protocols/amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (e.g., NDA, IND, MAA)
- Perform independent QC reviews of regulatory documents
- Verify accuracy and internal/external consistency versus source materials
- Define and confirm QC scope with authors; identify and ensure availability of required source documents/data
- Ensure adherence to style guides (e.g., AMA Manual of Style) and regulatory templates/guidance; document discrepancies and recommended corrections
- Proofread and copyedit for clarity, grammar, spelling, punctuation, and consistent messaging while preserving scientific/regulatory accuracy
- Support inspection-ready technical documents for global submissions (e.g., eCTD/CTD), including integration of narrative, tables, graphs, charts, and statistical output
- Communicate QC findings to medical writers/stakeholders and support issue resolution and timely deliverables
- Facilitate document workflow/project management (KOM through handoff to publishing) and maintain trackers/timelines
- Contribute to continuous improvement of QC tools, checklists, and processes
Qualifications:
- Bachelor’s degree and 5+ years of relevant experience; advanced degree in science/medical field is a plus
- Working knowledge of key eCTD/CTD documents and familiarity with CTD/eCTD structure and templates
- Understanding of drug development and regulatory submission processes; familiarity with ICH and major health authority expectations (e.g., FDA, EMA)
- Exceptional attention to detail; strong analytical/critical-thinking skills
- Ability to manage multiple priorities in a deadline-driven environment with independence/accountability
- Cross-functional experience and relationship-building
- Experience with electronic document management/publishing systems (e.g., Veeva Vault)
- Experience with project/timeline management systems (e.g., SmartSheet)
Application instructions: Applicants must currently be authorized to work in the U.S.; Vir Biotechnology is unable to sponsor or take over sponsorship of an employment Visa at this time.
Vir Biotechnology is looking for a Regulatory Writer (Temporary).
Responsibilities:
- In partnership with a lead author, write and edit regulatory documents including clinical trial protocols/amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (e.g., NDA, IND, MAA)
- Perform independent QC reviews of regulatory documents
- Verify accuracy and internal/external consistency versus source materials
- Define and confirm QC scope with authors; identify and ensure availability of required source documents/data
- Ensure adherence to style guides (e.g., AMA Manual of Style) and regulatory templates/guidance; document discrepancies and recommended corrections
- Proofread and copyedit for clarity, grammar, spelling, punctuation, and consistent messaging while preserving scientific/regulatory accuracy
- Support inspection-ready technical documents for global submissions (e.g., eCTD/CTD), including integration of narrative, tables, graphs, charts, and statistical output
- Communicate QC findings to medical writers/stakeholders and support issue resolution and timely deliverables
- Facilitate document workflow/project management (KOM through handoff to publishing) and maintain trackers/timelines
- Contribute to continuous improvement of QC tools, checklists, and processes
Qualifications:
- Bachelor’s degree and 5+ years of relevant experience; advanced degree in science/medical field is a plus
- Working knowledge of key eCTD/CTD documents and familiarity with CTD/eCTD structure and templates
- Understanding of drug development and regulatory submission processes; familiarity with ICH and major health authority expectations (e.g., FDA, EMA)
- Exceptional attention to detail; strong analytical/critical-thinking skills
- Ability to manage multiple priorities in a deadline-driven environment with independence/accountability
- Cross-functional experience and relationship-building
- Experience with electronic document management/publishing systems (e.g., Veeva Vault)
- Experience with project/timeline management systems (e.g., SmartSheet)
Application instructions: Applicants must currently be authorized to work in the U.S.; Vir Biotechnology is unable to sponsor or take over sponsorship of an employment Visa at this time.