Senior Director of ITS
A specialty pharmaceutical company engaged in the development, manufacturing and marketing of generic and proprietary injectable and inhalation products.
ITS Infrastructure and business Operations, ERP, LIMS, SAR, PIMS Application Service, Clinical Trial Data Management and Statistical Analysis. FDA Part 11 compliance, Server and application validation compliance, eCTD Submission data and coding specification, CDISC’s SDTM and ADaM specification and compliance
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