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Manager Medical Services

Job Description

Responsibilities: This position is responsible for providing highest level quality assurance of AR /AR Amendment/PADER/PMA documents and assistance in execution of the process for generating these regulatory documents.  This role includes quality assessment of both the regulatory documents and the  process to ensure the following:
1) that all studies are appropriately classified for inclusion/exclusion
2) that all reportable studies sponsored by sanofi are included in the report
3) that comments in the spreadsheet are accurate
4) that study synopses for completed clinical studies meet the established standards
5) validation of all documentation for the ARs and/or amendments, e.g., NDA (New Drug Application), PADER (Periodic Adverse Drug Experience Report), and PMA (Pre-Market Approval) for submission to the FDA. 
 
In addition, the incumbent will track and analyze analyses errors to identify root causes and to recommend remediation strategies aimed at reducing error rates.  Finally, this role will provide back-up support in the generation of these regulatory documents and the candidate will be fully knowledgeable of the process.

Job Requirements

Requirements:
Bachelor's Degree Required
The position requires extensive knowledge of the regulatory requirements or NDA ARs, including knowledge of pharmaceutical clinical trial process and AR documentation requirements.  This position requires ability to work under tight timelines, and excellent attention to detail is essential. The incumbent will need strong skills in Excel, and the ability to work with databases, e-rooms, and clinicaltrials.gov, etc. in an electronic environment.  Prior experience working as a Clinical Trials Manager within the pharmaceutical industry is preferred. 

Job Snapshot

Post Date 9/14/2014
Location Charlotte, NC
Employment Type Full-Time
Job Type Health Care
Education 4 Year Degree
Experience Not Specified
Manages Others Not Specified
Industry Healthcare - Health Services
Required Travel Not Specified
Job ID 37280
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