SUMMARY

• 8+ years of professional experience as a Business Analyst in Pharmaceutical 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.
• Strong understanding of Project Life Cycle and SDLC Methodologies including RUP, RAD, Scrum, Waterfall and Agile.
• 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.
• Expertise in GRC administration and also involved in the entire SDLC lifecycle of role creation from analysis, design, test, implement, and administration of roles in production.
• Proven experience with end-to-end business process mapping, business and technical requirements analysis, business planning, modelling, verification and methodology.
• Extensive knowledge of Biomedical/ Pharma industry compliance and regulatory standards like HIPAA, EDI, ANSI X12, SOX, ISO, CMM, Joint Commission, GMP, and GxP.
• Expertise in Pharmacy Benefits management (PBM) program using encrypted FTP data feeds.
• Expertise in Laboratory Information Management System (LIMS), Clinical Trial Management System(CTMS), Pharmaceutical lifecycle management (PLCM)
• Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation and Validation of Laboratory Information Management System (LIMS).
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science and Health Care Industries and cGMP, GCP, GLP, CAPA, GRP, EMR, EHR &QMS. Strong Working Knowledge of SDLC, GRC, 21CFR Part 11 and software FDA validation practices.
• Experienced in analysis and interpretation of supply/demand forecasts of the publicly-available EIA and IEA reports
• Proficient in MS Office Excel (Pivot Tables, VLOOKUP’s, Hookups, Macro), Access, PowerPoint, Visio.
• Considerable expertise in Metadata Management, Data Profiling & Quality, Data Governance and Master Data management (MDM)
• Well - versed in Excel functions, including Macros, and their applications in financial modeling, forecasting, and analysis
• Extensive experience in conduction GAP analysis with using Mercury Quality Center.
• Strong experience with Test Case Management using Mercury Quality Center, Black-box testing, device testing, integration testing, regression testing, User Approval Testing (UAT).
• Knowledge of Software Quality Assurance, Software Quality Metrics, and Software Quality Standards. Interacted with the development and testing teams to analyze overall quality of data.

PROFESSIONAL EXPERIENCE

Confidential, New York City, NY

Sr. Business Analyst

Responsibilities:

• Performed Requirement Gathering & Analysis by actively soliciting, analyzing and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
• Worked with project manager, SMEs and assisted with the implementation of the Labware LIMS.
• Performed business and system requirements, program functions, best practices (GMP, GLP), FDA validation, and 21 CFR Part 11 conditions in a highly regulated environment, for submission of regulatory documents pertaining to drug development.
• Conducted gap analysis, identified the potential changes and documented requirements across different systems, including Sales Force CRM, DI, MDM etc.
• Analyzed and translated business requirements into system specifications utilizing UML and RUP methodology.
• Identified and documented business processes for LIMS and captured As-Is and To-be workflow process diagrams to illustrate data exchange
• Worked on project life cycle and SDLC methodologies including RUP, Scrum, RAD, Waterfall and Agile.
• Execute business analysis processes to facilitate the user/function/design relationships within the LIMS system including documentation and test scripting.
• Conducted GAP session and do meeting with subject matter experts to identify and document all functional requirements forLIMS.
• Worked closely with Team members to implement GRC 5.3 Support packs 13.
• Implement CTMS to centralize all trial-related information, and improve clinical data management by equipping staff, including biostatisticians and database administrators.
• Extensively worked with Case Report Forms (CRF) during database design and developed various macros to filter data for phase II and phase III of clinical trials.
• Prepare presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
• Worked on preparing the compliance report featuring the existing status of the cGLP, cGMP sensitive computerized systems.
• Prepared FDA/Regulatory Readiness Reports for IT supported GMP systems that included SDLC documentation assessment, Training completion assessment, Physical and Logical Security, Change Control, Deviations, Disaster and Recovery Planning.
• Participated in performing and communicating Risk Assessment pertaining to Labwrae LIMS validation to the quality team and higher management
• Experience in the area of planning, administrating, developing and delivering automated GRC solutions using variousGRC tools(RSA Archer eGRC Framework, Metric Stream).
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.

Confidential, San Diego, CA

Business Analyst

Responsibilities:

• Coordinated and conducted requirements gathering session with senior stakeholders and project managers, reviewed quantitative and qualitative results, and provided recommendations for better use of systems across the agency.
• Created and updated Software Development Life Cycle (SDLC) documentation, such as aBusiness Requirement Document (BRD) and Functional Requirements Document (FRD) and Software Requirements Specifications (SRS).
• Participated in the peer review process of FRD documents and other work products prior to client submission.
• Participated in requirements gathering meetings with Veeva Professional services team along with RIM business owner and Project Manager, provided technical inputs on design of QC.
• Conducted JAD and working sessions to discuss and prioritize requirements and resolve project related issues.
• Analyzing and customization of existingVEEVA CRMfunctionality.
• Actively involved in meetings with development team to discuss process flow and other development issues.
• Proficient in business process modelling (BPM), documentation, and testing using Rational Suite as well as MS Project in combination with UML 2.0 diagramming techniques. Used Rational Rose to generate various UML Diagrams.
• Managed implementation of salesforce CRM and dropbox and courier management module in a customized LIMS.
• Worked with different business groups to get new Veeva enhancement requirements.
• Worked on documenting Requirement Traceability Matrix (RTM) for traceability of requirements and responsible for end to end traceability of drugs from RECAP to RXCLAIM.
• Interacted with users, developers, project manager and processanalyststo understand thebusiness process, identify enhancements and gatherbusinessrequirements.
• Worked with development team on design and implementation of enhancements to GxP project within RIS (Radiologically Isolated Syndrome) Preclinical department usingLabwareLIMS, WatsonLIMS and Crystal Reports.
• Worked with the Data warehousing team in writing SQL queries to test data in the financial oracle database.
• Extensively worked with Case Report Forms (CRF) during database design and developed various macros to filter data forphase II and phase III of clinical trials.
• Designed and executed Test Cases for system testing, regression testing and Integration Testing/End to End Testing in HP ALM
• Involved in UAT of applications by providing users with test cases and scenarios and also guided them throughout the testing

Confidential, Palatine, IL.

Business Analyst

Responsibilities:

• Gathers requirements for the new Pharmacy Benefits Management system (PBM) from the Vendor Drug as-is contracts documentation
• Analyzed User Requirements Document, Business Requirement Document (BRD), Technical Requirement Specification and Functional Requirement Specification (FRS).
• Played a lead role in the annual planning process across the S&OP planning team. Ensure linkage to monthly volume forecast as part of financial forecasting process.
• Involved with all the phases of Software Development Life Cycle (SDLC) methodologies throughout the project life cycle.
• CreatedFunctional, Technical specificationsand use cases for new CTMS Reports.
• Work with end users in establishing requirements, defining reports and testing the new CTMS system
• Wrote Business Requirements Document (BRD), analyzed them and tested them.
• Gathered requirements by using interviews, requirement workshops and brainstorming and JAD sessions.
• Designed report templates based on the requests by account managers.
• Participated in process of preparing VMP (verification master plan) to describe clearly and concisely the company’s philosophy, expectation and approach to be followed
• Documented all aspects of the computer system validation lifecycle, in accordance with FDA regulation which includes validation plan and protocol, Installation Qualification (IQ), Operational Qualification (OQ) and specification performance
• Created UML Diagrams including Use Case Diagrams, Activity Diagrams, Sequence Diagrams, Collaboration Diagrams, Data Flow Diagrams (DFDs) and ER Diagrams.
• Worked with CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators.
• Developed statistical programs to perform clinical data analysis, review and approve results by using R and JMP
• Resolve clinical queries daily that are generated by sponsor or CRO clinical data managers and clinical monitors at their site visits, to meet sponsor database lock timelines.
• Served as conduit for managing system requirements between the business and the software development team.
• Proficient in conducting Business process modeling (BPM), feasibility studies, Impact Analysis, Gap Analysis and Risk analysis
• Conducted acceptance tests to verify that the validation effort was complete.
• Played an active role in the UAT and the release of CTMS integration project.
• Prepared UAT Materials UAT Test Cases to include various steps involved for UAT and to have proper coverage of requirements.

Confidential, Plano, TX.

Business Analyst

Responsibilities:

• Actively involved in creating and updating the templates for the different folders and eCRFs in each application based on phase IV trials from CTMS.
• Worked with internal team, CROs and clinical sites to ensure the tracking and timely conduction of clinical studies.
• Performed Requirement Analysis to understand user needs for data Toxicology/ Pharmacology n-tier system.
• Involved in validation ofLab wareLIMSand Open Lab including editing and review of protocols and post execution review for IQ and OQ effort.
• Developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modeling.
• Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time-out for theLIMSsystem.
• Ensure an alignment of Demand Forecast with Sales Estimate and/or provide reconciliation and analysis of variance
• Worked with CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators.
• Participated in the analysis, design and automation of client/ server applications using Oracle and SQL.
• Worked with CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators
• Involved in preparing the compliance report featuring the existing status of the cGLP, cGMP sensitive computerized systems.
• Prepared FDA/Regulatory Readiness Reports for IT supported GMP systems that included SDLC documentation assessment, Training completion assessment, Physical and Logical Security, Change Control, Deviations, Disaster and Recovery Planning.
• Involved in validation ofLabwareLIMSby developing, executing and documenting SOPs, Test Plans and Test Scripts.
• Wrote test scripts for User Acceptance Testing (UAT).
• Participated in performing and communicating Risk Assessment pertaining to Labwrae LIMS validation to the quality team and higher management.

Confidential, Smyrna, Georgia

Business Analyst

Responsibilities:

• Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile (Scrum).
• Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module. ValidatedLabWareLIMSto meet 21 CFR Part 11 FDA Regulations.
• Created Validation plan for Laboratory Data system and Computer Systems (CDS, SDMS, ELN) interfaced withLIMS.
• Created templates for method validation protocol, method validation report, standard test method.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced withLIMSfor 21 CFR Part 11 compliance and prepared Deviation Reports.
• Prepared specification documents for Labstation module ofLIMSand created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments withLIMSLab Ware.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Developed Traceability Matrix matching URS and UAT for various release efforts forLabwareLIMS. Executed OQ and PQ test scripts and generated Test Summary Reports. Interacted with the Lead user and wrote PQ scripts and was responsible for User Acceptance Testing (UAT).
• Participated in performing and communicating Risk Assessment pertaining to Labwrae LIMS validation to the quality team and higher management.
• Responsible for creating test scenarios, scripting test cases using testing tool and defect management for Policy Management Systems, Payables/Receivables and Claims processing.
• Engaged with QA teams as a product SME and ensured smooth testing.
• Conducted acceptance tests to verify that the validation effort was complete