THE OPPORTUNITY
Vir Biotechnology is looking for a Principal 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 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, internal/external facing labeling documents (eg, CCDS/CCSI, annotated draft labels, IFU, patient leaflets, etc), 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 medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents
- Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents
- 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 and 15 to 20 years of relevant experience required. Advanced degree in science or medical field is a plus
- Experience with all common study-level and submission-level regulatory documents such as CSRs, IBs, DSURs, protocols, and eCTD modules required
- Proven experience with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents) including responses to health authorities, 90/120-day safety updates, or other post-submission activities required
- Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs
- Proven ability to manage complex projects and influence cross-functional teams
