Senior Regulatory Writer
$130 - $170 per hourTemporary
Vir Biotechnology
Role Description
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.
- 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
- 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.
Qualifications
- 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.
Requirements
- #LI-AS1
- #LI-Remote
Benefits
- The expected hourly range for this position is $130.00 to $170.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vacancy posted 11 hours ago
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