SUMMARY

• Over all 6+ years of professional experience as a Business Analyst in Life Sciences / Pharmaceutical / Pharmacy Benefit Management PBM domain. Extensive experience in analyzing and requirements gathering and writing system functional specifications including use cases. Proven success as a business analyst through the years, providing a well - balanced understanding of business relationships, business requirements, and technical solutions.
• Proficient in developing Use case scenarios to enable design and development of applications using tools like Rational Requisite Pro, JIRA and VersionOne based on the SDLC methodology.
• Used QC/ALM in executing the test cases, logging them and directing it to the right team for any issues encountered during the testing phase.
• Knowledge of 837, 835, 277, 270, 271, NCPDP and experience in implementation of HIPAA and NCPDP standards.
• Lead user story creation in complex biotech/pharma business domain for Medical Affairs to increase response time and effectiveness to Genentech's pharma product lines
• Expertise in UML (class diagrams, object diagrams, GAP Analysis, use case diagrams, state diagrams, sequence diagrams, activity diagrams, and collaboration diagrams) as a business analysis methodology for application functionality designs using IBM’s Rational Rose. Experienced at creating and designing LabWare LIMS Electronic Laboratory Notebook templates.
• In depth knowledge in Agile, Scrum, Waterfall, Rational Unified Process (RUP) methodology, GxP, Use Cases, Software Development Life Cycle (SDLC) processes
• Expertise in developing QA Test Plan, Test Conditions, and Test Cases; ensuring adequate testing of software both before and after completion.
• Design and review of various documents including the Software Requirement Specifications (SRS), Business requirements document (BRD), Use Case Specifications, Functional Specifications (FSD), Systems Design Specification (SDS), Requirement Traceability Matrix (RTM) and testing documents
• Proven success as a business analyst through the years, providing a well-balanced understanding of business relationships, business requirements, and technical solutions.
• Professional experience in business analysis, operations management and development, design, documentation and testing.
• Excellent Analytical, methodical, and resourceful approach to problem solving, identifying and documenting root causes and corrective actions to meet short and long term business and system requirements.

TECHNICAL SKILLS

Operating Systems: Windows, Unix

Application Software: MS Office suite, Rational Suite, MS Project

Databases: SQL Server, Oracle, MS Access, DB2

Web Technologies: HTML, XML, XSLT, web services, SOAP, SOA, HTML

Methodologies CRM: RUP, Agile, Waterfall

Process Modeling: MS Visio, Rational Rose CRM Salesforce, Veeva

Microsoft Technologies: MS Project, Visio, Excel, Word, Outlook, PowerPoint

PROFESSIONAL EXPERIENCE

Confidential

Sr. Business Analyst

Responsibilities:

• Interacted with clients to gather all requirements to formulate business specifications and translate those into application functionality, decide when to advocate and when to compromise to arrive at a mutually acceptable solution.
• The project/s involved various development, enhancement, production and R&D support activities connected to clinical microbiology.
• Gathered and documented requirements for Pharmacy benefit managers (PBMs) for health insurance carriers Coordinate distribution of SOPs to Pharm Sci.
• Good knowledge in generating automated/manual test scripts, working on various test strategies and preparing Test Plans, Test Cases and analyzing test results, Qualification Protocols (IQ,OQ,PQ) as per principles of software validation.
• Developed a Legacy Document Conversion Utility (LDCU) Tool that converts legacy documents documents migrated from a legacy docbase to Pharm Sci control documents.
• Performed the requirement analysis, impact analysis and documented the requirements using Rational Requisite Pro and Utilized Agile experience with large and small teams.
• Maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GxP Quality guidelines.
• Gained extensive knowledge and understanding of MITA, MMIS, Electronic Medical Health Record EMHR and Pharmacy Benefit Management PBM.
• Serve as the JIRA / Atlassian technical resource (Subject Matter Expert for migrations to ensure adoption of development/workflow processes.
• Reviewed product promotional materials, packaging, labeling, batch records, specification sheets and test methods for compliance with applicable regulations and policies.
• Participated in meetings to establish and enforce SharePoint best practices and standards manage proper security group naming conventions & security assignment processes
• Worked at different stages of the Software Development Life Cycle (SDLC) with business users, developers, and stakeholders.
• Adept with different SDLC methodologies- Waterfall, Rapid Application Development RAD, Rational Unified Process RUP and Agile SCRUM .
• Involved in creating test cases for 834, 837, 820, 270/271 transactions and validating the EDI files. Performed Gap Analysis by identifying existing technologies, documenting the enhancements to meet the end-state requirements.
• Assisted the technical team in translating application functionality into application architecture and the production of a System Functionality document.
• Assisted JAD sessions to identify the business flows and determine whether any current or proposed systems are impacted by the EDI X12 Transaction, Code set and Identifier aspects of HIPAA.
• Involved in mentoring specific projects in application of the new SDLC based on the RUP, especially from the project management, requirements and architecture perspectives.
• Responsible for the Design and execution of test plans to ensure that business requirements and functional specifications are tested and fulfilled.
• HIPAA EDI transactions of 270/271, 834, Medicaid/MMIS 820, 276/277, 275, 835, 278 and 837 I/P/D, ACT/Obama Care, HIPAA ANSI X 12 4010/5010 , and PBM.
• Conducted FRS (regulatory) and URS reviews and walkthroughs with the designers, developers and stakeholders. Documented Test Plans that contains test scripts, test cases, test data and expected results for the User Acceptance testing.

Confidential

Business/ Systems Analyst

Responsibilities:

• Developed and executed validation guidelines for testing the GMP, GCP, GLP sensitive transactions. Understand the business needs and designed use cases, functional specifications and implemented the same as per requirements.
• Wrote SQL queries for each Test case and executed in SQL Plus to validate the data between Enterprise Data Warehousing and Data Mart Staging Tables.
• Working on regulatory reporting framework and Reporting domain projects like Basel Reporting, CCAR, and Liquidity Reporting.
• Exposed to all phases of SDLC (Requirements, Analysis, Design, Development, Implementation and Testing) following V Model, Waterfall, and Agile (Scrum) methodologies.
• Worked primarily with LabWare LIMS (v6, v7), ELN, LIMS Basic, SQL, Crystal Reports, and HP ALM.
• Responsible for business system analysis of customizing the BPS Risk Management product with involvement through the whole SDLC. Used Documentum for storage, retrieval and classify the clinical research data.
• SMEs (Subject matter Experts), reported owners to recommend processes for new implementation of (GxP) or (non-GxP) Cognos Reports. Worked with FDA guidelines (21CFR Part 11), HIPAA (Health Insurance Portability and Accountability Act).
• Used Agile methodology to gather requirements and work with the development and testing team Produced requirements and system work products including: Business process and data flow diagrams, Use cases/User Stories, Wireframe
• Validated SQL queries used to extract data from our database for clinical and research purposes Lead and coached the organization in its scrum adoption - working with other Scrum Masters (cross vertical teams) to increase the effectiveness of the application of scrum in the organization.
• Responsible for applying regulations based on Basel III, which further can be implemented into DFAST and CCAR, which help to project Liquidity Impact.
• Involved in validation of Oracle Clinical business processes in accordance with EMEA and FDA regulations.
• Used JIRA to perform test management activities and used JIRA tool to track and maintain different versions of the project documentation.
• Creates and maintains Source-to-Target data mapping specifications for data stored in the big data platform. Ensure source data definitions are correctly implemented in the big data platform.
• Supported and educate end users with Epic clinical applications and associated clinical and operational workflows
• Involved in interactions with the Subject Matter Expert, Project Manager, Developers, and the end-users to gather key issues involved in the project and propose the new solutions.
• Used the guidelines of the Rational Unified Process (RUP) to strategize the Implementation of Rational Unified Process effort in different iterations and phases of the project.
• Conducted User Acceptance Testing for Business Objects Reporting for eQRMS GxP Reports, GxPChange Control
• Supported the assigned project manager with creating detailed project plans; assisted in developing, scheduling and tracking project timelines.

Confidential

Business Systems Analyst

Responsibilities:

• Extracted the Business Requirements from the end users keeping in mind their need for the application and prepared Business Requirement Documents (BRD) using Rational RequisitePro. Reviewed Design Documents, Requirements Analysis Specifications with Project Lead, Business Owners and the Technical Lead.
• Reviewed documents of URS, FRS and DS in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
• Wrote Standard Operating Procedures (SOP's) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
• Performed impact analysis if claims processing errors are discovered. Worked with PBM to resolve member pharmacy claims issue.
• Involved in all phases of Software development life cycle SDLC using Agile Scrum methodology and Rational Unified Process RUP
• Capture Feature/Function information at varying levels of granularity and document them in a requirements management tool (e.g. Microsoft TFS, JIRA, etc.)
• Critically evaluated information gathered from multiple sources and worked with customers to assess whether data conformed to data governance approved mappings and standards.
• Ensuring and Coordinating that the CMC documentation of the product comply with the regulations of the Medicines and Healthcare products and Regulatory Agencies of different countries.
• Prepared and executed validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers and refrigerators for the start - up facility; actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project for Pharmica Biotechnology.
• Implemented enterprise integration strategies for HIE(Healthcare Information Exchange), CCD (Continuity of Care Document), Medical Summary, PHR( Personal Health Record).
• Worked on Pharmacy Systems' Condor Rx-90, CS-90, and CS-90+ prescription management systems
• Assigned tasks among development team, monitored and tracked progress of project following agile methodology.
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose. Wrote Test Cases and performed User Acceptance Testing, documented the in detail defects using the Defect Tracking report.
• Involved in creating automated Test Scripts representing various Transactions, Documenting the Load Testing Process and Methodology. Created meaningful reports for analysis and integrated the Performance Testing in the SDLC.
• Conducted Functional Walkthroughs, User Acceptance Testing (UAT), and supervised the development of User Manuals for customers.
• Worked as a User/Customer advocate and negotiated with user as well as with developers and management staff to resolve any requirement conflict to bridge the Gaps between IT and Business.
• Various versions of the documents generated during the project were maintained and managed using Rational ClearCase and performed defect tracking using Rational ClearQuest.
• Tested the final application for Usability testing to verify whether all the User Requirements were catered to by the application.