Associate Director of Medical Writing

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