Senior Regulatory Writer
New
V
Vir BiotechnologyBiotechnology
Remote - United StatesContractSenior
Salary130 - 170 USD per hour
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Job Details
- Experience
- 7 to 10+ years of industry experience; at least 8 years of experience as a regulatory writer in biotechnology or equivalent.
Requirements
- Bachelor’s degree required; advanced degree in science or medical field is a plus
- At least 8 years of experience as a regulatory writer in biotechnology or equivalent
- 7 to 10+ years of total industry experience
- Experience with 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 or post-submission activities
- Expert understanding of eCTD structure and the clinical development process
- In-depth knowledge of document-related ICH guidelines and GxPs
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
- 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
- Work closely with cross-functional teams (e.g., clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety) 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, and support interaction across functional areas
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