Charlotte, North Carolina
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Today
Responsibilities: Lead the development and implementation of submission-ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA). Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Perform thorough quality control checks to validate the accuracy and completeness of submission datasets. Coordinate the preparation and documentation of submission packages, including data specifications and v
Full-time