Medical Writing Consultant

Job Summary

To support client regulatory strategies, the remote Medical Writing Consultant I will author and manage regulatory documents, lead document development efforts, and ensure high-quality deliverables that meet client expectations and regulatory standards.

Key Responsibilities

• Author a variety of regulatory documents, including Clinical Study Reports and study protocols
• Lead the development of complex regulatory modules and ensure submission readiness
• Serve as a project owner by tracking timelines and coordinating with clients to address evolving 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 or regulatory writing
• Proficiency in Microsoft Office Suite and familiarity with regulatory document management systems
• Experience with regulatory submissions and understanding of global regulatory standards
• RAC certification is beneficial