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Ensures compliance with cGMP/cGLP and good documentation procedure during the review process Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses Informs the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity Reports all audit finding in the ODR audit works...
About the Role
The Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.
Area Of Responsibility
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