Medical Review Manager Job in Piscataway, New Jersey US
319 MEDICAL REVIEW MANAGER
Medical Review Manager position available in Cardiovascular.
RESPONSIBILITIES
1. Medical review of Narratives required as part of the FDA Submission
2. Coordinate efforts with Medical Operational Manager to develop and update Narrative Guidelines
3. Identify issues and trends in draft documents that require updates to guidelines.
4. Make minor corrections to Narratives as needed.
5. Review sample drafts written by proposed medical writers and provide feedback to Medical Operational Manager
6. Regularly update Medical Monitor on quality of narratives and solicit guidance as needed
7. Interact with the regulatory team on narratives
8. Coordinate with the operational manager for publishing and hyperlinking of the narratives
9. Provide medical review of other study submission documents including coding on an ad hoc basis.
REQUIREMENTS
10. Medical review experience
11. Preferred management experience
12. M.D. or D.O. and previous pharmaceutical/medical experience
APPLY ONLINE:
To expedite the application process we invite you to apply to our HRStaffers applicant portal. The application process should take less than five minutes. To do so, please go to http://portals.aviontego.com/Spectrum/Main.aspx?App=1CompanyID=Spectrum