Senior Regulatory Writer (Temporary)
$270,400–$353,600 year
RemoteUnited States
Job Summary
Craft clear, accurate, and compliant documents for regulatory submissions to global health authorities including FDA and EMA. Write and edit clinical trial protocols, Investigator Brochures, Clinical Study Reports, and components of regulatory submission dossiers. Analyze complex scientific and medical information to translate it into language understandable by both technical and non-technical audiences. Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress. Provide guidance on best practices and industry standards while collaborating with cross-functional teams to ensure comprehensive and accurate document content.
Required Qualifications
- Bachelor's degree
- 7 to 10+ years of industry experience
- Advanced degree in science or medical field preferred
- 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
- In-depth knowledge of document-related ICH guidelines and GxPs
- At least 8 years of experience as a regulatory writer in biotechnology or equivalent
- Must be authorized to work for any employer in the U.S.
- Must be available for remote work
Desired Qualifications
- Advanced degree in science or medical field is a plus
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