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.