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 powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. They are seeking a Senior Regulatory Writer (Temporary) to support all aspects of regulatory submissions writing needs, collaborating with senior management to ensure consistent documents and messaging across programs.
Responsibilities
- 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
Skills
- Bachelor's degree and 7 to 10+ years of industry experience required
- 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
- Advanced degree in science or medical field is a plus
Benefits
- #LI-Remote
- Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
- Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
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