Senior Specialist It Business Analyst
CurrentOn the Plan/Build Team for Quality/Regulatory Portfolio for Document Management and Regulatory Submission Applications: • Adheres to Abbott’s SLC process for computerized system validation/certification to build in quality during the process from initial requirements gathering through retirement. • Collaborates and builds business relationships with PMs, BRMs, BPOs, SQAs, Support Owners, Primary IT Leads, Architects, Cybersecurity, DLM, Disaster Recovery, Data Privacy, VRM, and Vendors.• Facilitates meetings with SMEs to ensure quality documentation, such as SRC, VRA, CR, PVP, DPP, DLM, URS/FRS, DMP, BIA, IDPR, OQ, TM, UAT, and SCS, is completed before deliverable due date. • Completed 23 (16 Document Mgmt and 7 Regulatory Submissions Mgmt) projects for Abbott Nutrition, Medical Devices (Vascular), and Diagnostics (Core and Rapid) divisions. • Subset of accomplished projects for Quality Non-Critical systems:- Upgraded quality document management system, fixed defects, and added enhancements.Replaced unsupported system and migrated data to new system and RIMS.- Implemented new regulatory submissions solution including registrations and submissions.- Replaced unsupported system with regulatory information management (RIM) product. - Upgraded custom document repository to restore application health.- Replaced SharePoint site with global, cross-functional, validated claims management system that allows management of claims metadata, documents, and review and approval process. - Implemented Session Termination to meet required technical security control.