Clinical Regulatory Writer

Job Summary

To support the development and management of clinical and regulatory documentation, the fully remote Clinical Regulatory Writer will prepare clinical reports, summary documents, and package inserts while ensuring compliance with internal and regulatory standards.

Key responsibilities

• Develop, review, edit, and finalize clinical reports and regulatory documentation
• Support electronic regulatory submission processes and ensure submission readiness
• Coordinate timelines and deliverables for clinical documentation projects while managing multiple concurrent projects

Required qualifications

• Bachelor's degree or equivalent experience required
• 4+ years of experience in clinical writing or regulatory writing within a regulated environment
• Experience supporting clinical or regulatory submissions preferred
• Strong understanding of medical device, pharmaceutical, or healthcare documentation standards
• Experience with electronic submission systems and document management tools preferred