Associate Director of Medical Writing

Job Summary

To support the development of complex clinical and regulatory documents, the full-time Associate Director of Medical Writing will manage medical writing processes, ensuring compliance with standards while collaborating with cross-functional teams in a remote environment.

Key responsibilities:

• Primary author of regulatory documents including protocols, IBs, and CSRs, ensuring accuracy and compliance
• Engages subject matter experts to develop high-quality content and facilitates standardization of documents across programs
• Manages a team of medical writers and oversees multiple projects to meet corporate objectives and deadlines

Required qualifications:

• Bachelor's degree in a scientific or clinical discipline; PhD preferred
• Minimum of 5 years of clinical/regulatory medical writing experience in pharma or biotech
• Fluent in American English with strong writing and proofreading skills
• Experience with eCTD Module 5 and Module 2 writing for global marketing applications
• Basic understanding of scientific methodology and regulatory guidance for medical writing documents