Description
Professional Summary: * 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry. * Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications. * Expertise in implementing Waterfall and Agile Scrum Methodologies throughout the Software Development Life Cycle of the project. * Strong knowledge in pharmaceutical/medical device regulations such as FDA 21 CFR Part 11. * Extensive experience in HIPAA, ICD 9/10, Crystal Reports and MDM * Implemented Unified Modeling Language (UML) methodologies to design Use Case Diagrams, Data Flow Diagrams, Activity Diagrams, Sequence Diagram and ER diagrams * Responsible for Gap analysis in HIPAA 4010 to HIPAA 5010.Incorporated and implemented all the HIPAA standards, Electronic Data Interchange (EDI), transaction syntax like ANSI X 12, ICD-9, ICD-10 coding. * Adequate knowledge in Healthcare Administration - Claims processing (auto adjudication), COB, EOB/Drafts, Claims pricing and testing, HIPAA, Pre authorization, enrolment, EDI, Medicare, Medicaid, CDHP (consumer driven health plans). * Strong knowledge of FDA QS, CFR 211 for Pharmaceutical, Clinical Trial, Life Science and Health Care Industries. * Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines. * Strong Working Knowledge of SDLC, GRC 21CFR Part 11 and software FDA validation practices * Involved in Trouble Shooting, Performance tuning of reports. * Automating import of data into the application. Submission, error resolution, and audit CMS (PDE and RDS). * Worked closely PMO on Duration Analysis, Cost Benefit Analysis and RACI Analysis. * Extensive experience in using Microsoft Visual studio suite and HP ALM for writing functional and non-functional User stories and test cases. * Has experience in conducting Unit Testing, Integration Testing, System Testing, User Acceptance Testing (UAT) and documentation of test cases. Expertise in designing and developing test plans. * Ability to organize, document and track changes and defects using JIRA, Rational Clear Quest and archive change request in Clear Case * Extensive experience in using business process tools such as MS Project, MS Excel, MS Access, MS Visio, technical assessment tools, Business objects. * Excellent Team player and capable of working independently, with excellent communication and interpersonal skills.
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