Regulatory Writer and/or Regulatory QC/ Editor (Temporary)
$187,200–$249,600 year
RemoteUnited States
Job Summary
Write and edit regulatory documents including clinical protocols, Investigator Brochures, Clinical Study Reports, and components of regulatory submission dossiers. Perform independent quality control reviews to verify accuracy, consistency, and adherence to style guides and templates. Proofread text for clarity and grammar while preserving scientific accuracy, and support inspection readiness for global submissions. Manage document workflows from kickoff through publishing, communicate QC findings to stakeholders, and contribute to continuous improvement of QC tools and processes. This temporary role reports to the Senior Director, Regulatory Writing.
Required Qualifications
- Bachelor's degree
- 5 plus years of relevant experience
- Working knowledge of the industry and content of key eCTD documents
- Familiarity with CTD/eCTD structure and common templates
- Understanding of drug development and regulatory submission processes
- Familiarity with ICH guidelines
- Familiarity with major health authority expectations (eg, FDA, EMA)
- Exceptional attention to detail
- Strong analytical and critical-thinking skills
- Ability to identify inconsistencies, data issues, and deviations from standards
- Proven ability to manage multiple tasks and priorities in a deadline-driven environment
- Operating with a high degree of independence and accountability
- Experience working cross-functionally in collaborative team environments
- Building effective working relationships with authors, reviewers, and project teams
- Experience with electronic document management and publishing systems (eg, Veeva Vault)
- Experience with project and timeline management systems (eg, SmartSheet)
- Must currently be authorized to work for any employer in the U.S.
- Unable to sponsor or take over sponsorship of an employment Visa
Desired Qualifications
- Advanced degree in science or medical field
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