Director of Medical Writing

Job Summary

Collaborating with cross-functional teams, the remote Director of Medical Writing will manage the preparation and finalization of regulatory documents, ensuring compliance and alignment with clinical development programs.

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 manage the document review process
• Develop and manage timelines for medical writing deliverables to ensure timely completion that meets business needs

Required qualifications:

• BA/BS degree in a scientific field; advanced degree (PhD, PharmD, or MS) preferred
• 10+ 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 in a fast-paced environment