About this opportunity
Hikma Pharmaceuticals lists this Senior Data Review Specialist, Regulatory Submissions opportunity in cherry hill township, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, seeks a Sr. Specialist, Data Review – R&D Injectables to lead the critical review of pre-submission data for regulatory filings. You will ensure Data Integrity, Reliability, Accuracy, and Traceability of submitted data under cGMP and SOP guidelines.
The role requires expert knowledge of FDA/ICH guidelines, AR&D data, and collaboration with scientific staff to resolve deviations and ensure timely, compliant submissions.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.