THE OPPORTUNITY

Vir Biotechnology is looking for a Senior Regulatory Writer (Temporary) who will support all aspects of regulatory submissions writing needs. You will collaborate with senior management and other leads to support consistent documents/messaging within and across programs.

This Person will report to the Senior Director, Regulatory Writing.

WHAT YOU'LL DO

• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including but not limited to FDA and EMA
• 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) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc)
• Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards
• Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences
• Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content
• Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress
• Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas

WHO YOU ARE AND WHAT YOU BRING

• Bachelor’s degree and 7 to 10+ years of industry experience required, advanced degree in science or medical field is a plus
• Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules
• Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities
• Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs
• At least 8 years of experience as a regulatory writer in biotechnology or equivalent