EPM Scientific
Director, Medical Writing
A leading, global biopharmaceutical company is seeking a highly skilled Director of Medical Writing. This role is pivotal in the Clinical Development function, and will lead the execution of regulatory and clinical documents.
Responsibilities:
- Develop a range of regulatory and clinical documents, including clinical protocols, IBs, CSRs, briefing books, submissions and more.
- Work cross-functionally with various teams.
- Ensure compliance with regulatory and industry standards in all written materials.
- Participate in strategic planning of medical writing projects.
Qualifications:
- 10+ years of medical writing experience in the pharmaceutical/biotech industry
- Experience with regulatory submissions and knowledge of regulatory guidelines (USA and European regulations).
- High attention to detail and commitment to quality.
***Must be willing to go on-site in New York City 4 days/week***