Associate Director of Medical Writing

Job Summary

Collaborating with cross-functional teams, the remote Associate Director of Medical Writing will prepare and finalize regulatory documents, manage writing timelines, and ensure compliance with regulatory requirements in a full-time capacity.

Key responsibilities

• Prepare, edit, and finalize clinical and regulatory documents, including protocols and clinical study reports
• Interact with document authors and reviewers to gather necessary input and facilitate the document review process
• Participate in refining medical writing processes and ensure efficient preparation of high-quality deliverables

Required qualifications

• BA/BS degree in a scientific field; advanced scientific degree (PhD, PharmD, or MS) preferred
• 8+ years of regulatory medical writing experience in the pharmaceutical industry
• Knowledge of oncology disease areas preferred
• Proficiency in MS Office applications, Adobe Acrobat, and electronic document management systems
• Ability to manage multiple projects simultaneously with minimal direction