Medical Writing Consultant

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