Regulatory Medical Writing Director

Job Summary

A company is looking for an Associate Regulatory (Medical Writing) Scientific Communications Director.

Key Responsibilities

• Leads content development for regulatory and clinical documents, ensuring high quality and organization
• Compiles and summarizes data to create descriptive text and tables for regulatory submissions
• Supervises junior writers and regulatory editors, proposing and managing timelines for document development

Required Qualifications, Training, and Education

• BS/BA, MS/MA, or PhD in a related discipline with relevant experience in the industry
• Prior regulatory/medical/technical writing experience in the biotech or pharmaceutical industry
• Experience leading content development for regulatory submissions (e.g., IND/NDA/BLA/MAA)
• Advanced knowledge of drug development processes and regulatory requirements
• Active AMWA membership and certifications preferred