Teams at Vir Biotechnology

Perform regulatory writing and editorial/QC for submission documents (protocols, IBs, CSRs, briefing packages, NDA/IND/MAA components). Verify accuracy and consistency versus source data, apply style guides and templates, proofread and copyedit, prepare eCTD/CTD submission materials, communicate QC findings, manage document workflows and timelines, and improve QC tools and SOPs.

Create, edit, and ensure compliance of regulatory submission documents (protocols, IBs, CSRs, Module 2/5 summaries) for global health authorities. Translate complex clinical data into clear text, coordinate cross-functional inputs, manage writing timelines, and advise teams on regulatory writing best practices to support IND/NDA/MAA and other submission activities.

Lead and produce high-quality regulatory submission documents (protocols, IBs, CSRs, Module 2/5 summaries, labeling, briefing packages) for FDA/EMA. Ensure compliance with ICH/GxP, manage writing projects and timelines, collaborate with cross-functional teams, and define SOPs and best practices.