Responsible to lead Veeva RIMS Vault management, maintaining roadmaps and lifecycle plans, developing proposals, managing related backlogs, leading and/or participating in Build/Run Squads, and ensuring the support of Make/Assess/Release in a worldwide GxP environment.

• Lead, devise and implement BioMarin Business process and technology Solutions for Clinical and Regulatory systems.• Managed implementation of Veeva Submission and Archive Vault.• Managed end-to-end Implementation/upgrade of various GxP Systems such as Veeva Submission Vault, R-Shiny, SAS, Study Data Tabulation Model (SDTM), ELN IDBS Workbook, Argus Safety, IDMP (Identification of Medicinal Products) Assessment project, iMedidata Coder, Custom PV Adverse Event Mobile application (iOS… Show more • Lead, devise and implement BioMarin Business process and technology Solutions for Clinical and Regulatory systems.• Managed implementation of Veeva Submission and Archive Vault.• Managed end-to-end Implementation/upgrade of various GxP Systems such as Veeva Submission Vault, R-Shiny, SAS, Study Data Tabulation Model (SDTM), ELN IDBS Workbook, Argus Safety, IDMP (Identification of Medicinal Products) Assessment project, iMedidata Coder, Custom PV Adverse Event Mobile application (iOS and Windows) Custom made Medical Information Request Form Mobile application (iOS and Windows), IRMS (Information Request Management System) and InSight upgrade.• Managed and assisted several end-to-end RFP/RFI assessment projects. Created High-Level Business Requirements for vendor selection, prepared RFI questionnaire, Vendor Scorecards, interviewed vendors, and negotiated price, service and reviewed SOWs with the legal team.• Effectively applied Information Management goal of moving to R&D systems to Cloud/SaaS model. • Led Process improvements for MedAffairs IRMS system by re-writing their validation process which led to future state reduction of efforts by 30%. • Led the technology process automation by converting manual Adverse Event and Medical Information request forms into Mobile Application forms and integrating the metadata with the backend system • Collaborate on Strategy and Roadmap definition for BioMarin Regulatory and Clinical Systems. Show less

Merck Research and Laboratory, IT

Served as a Business Analyst for various Pharma clients.