Senior Director of Medical Writing

Job Summary

A company is looking for a Senior Director, Medical & Regulatory Writing.

Key Responsibilities

• Provide leadership, strategy, and oversight of the Medical & Regulatory Writing team
• Serve as a subject matter expert in preparing clinical regulatory documents throughout all phases of clinical research
• Collaborate with cross-functional teams to ensure timely delivery of high-quality documents while adhering to regulatory standards

Required Qualifications and Education

• Bachelor's, Master's, or PhD Degree in a scientific, medical, or clinical discipline is required; Master's or PhD preferred
• 12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environment
• Experience authoring clinical study reports, protocols, and Investigator's Brochures; regulatory submission experience is a plus
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines
• Proficiency in MS Word and familiarity with document formatting tools and EDMS