Regulatory Writer

Job Summary

Supporting the quality and accuracy of regulatory documents, the temporary Regulatory Writer will work remotely to write, edit, and perform QC reviews of various regulatory submissions while collaborating with cross-functional teams.

Key responsibilities

• Write and edit regulatory documents including clinical trial protocols, Investigator Brochures, and Clinical Study Reports
• Conduct independent QC reviews, ensuring adherence to style guides and regulatory guidance
• Facilitate project management of document workflows and contribute to the continuous improvement of QC processes

Required qualifications

• Bachelor's degree with 5+ years of relevant experience; advanced degree in a science or medical field is a plus
• Working knowledge of eCTD documents and familiarity with CTD/eCTD structure
• Understanding of drug development and regulatory submission processes, including ICH guidelines
• Experience with electronic document management and publishing systems
• Proven ability to manage multiple tasks in a deadline-driven environment