Manager Of Medical Writing Madison WI

Title: Senior Manager, Medical Writing

Department: Medical Writing

Location: Greater Chicago Area

Employment Type: Full Time

Job Type: Regular

Essential Function:

The Senior Manager of Medical Writing, will research, create, and edit documents associated with the clinical sections of regulatory submissions and associated clinical documents. The Senior Manager of Medical Writing will manage writing projects, and act as a resource and mentor to other writers.

Key Responsibilities:

-Prepare, review, and edit key documents for regulatory submissions
- Provide technical leadership to ensure that clinical data presented in summary documents are in compliance with applicable regulatory guidelines, SOPs, and goals of submission.
- Advise on medical writing regulatory issues and submissions as detailed in current ICH, FDA, EMA and other applicable guidelines.
- In line with client requirements, devise and prepare medical writing deliverables for which little or no regulatory or other guidance is available, e.g., risk benefit assessment reports.
- Coordinate production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.

Initial phone screenings will be taking place in the first week of January so apply now!To find out more about Real Staffing please visit www.realstaffing.com