Medical Writing Consultant

Job Summary

To support diverse client needs in regulatory documentation, the remote Medical Writing Consultant will author and manage regulatory documents, lead complex module development, and ensure submission readiness while maintaining strong client relationships.

Key Responsibilities

• Author a variety of regulatory documents, including Clinical Study Reports and study protocols
• Lead the development of complex regulatory modules and apply quality control processes to ensure high-quality deliverables
• Serve as a project owner by tracking timelines and coordinating with clients to address project demands

Required Qualifications

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred
• 3+ years of industry experience in medical writing and regulatory submissions
• Proficiency in Microsoft Office Suite and familiarity with regulatory document management systems
• Strong foundation in medical writing and understanding of global regulatory standards
• RAC certification is beneficial