Medical Writing Consultant

Job Summary

To support a growing team, the remote Medical Writing Consultant I will author and manage regulatory documents, lead document development efforts, and ensure high-quality deliverables that align with 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 modules and apply quality control processes to 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 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