Note: The job is a remote job and is open to candidates in USA. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer. The Regulatory Writer will support the quality, consistency, and accuracy of regulatory documents by collaborating with cross-functional stakeholders and ensuring compliance with regulatory submission materials.
Responsibilities
- 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, and components of regulatory submission dossiers (eg, 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 (eg, 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 (eg, 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
Skills
- Bachelor's degree and 5 plus years of relevant experience
- 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 (eg, 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
- Advanced degree in science or medical field is a plus
- Experience with electronic document management and publishing systems (eg, Veeva Vault)
- Experience with project and timeline management systems (eg, SmartSheet)
Company Overview