- Around 6 years of experience in the field of Business/Systems Analysis, working with the technical staff to implement management and staff's business requirements into the software application in Pharmaceutical Industry.
- Extensively used rational tools for UML, tracking and reporting and applied the Rational Unified Process in all areas of a software development life cycle.
- Experienced in software development life cycle such as Waterfall, Agile - SCRUM methodologies, Business Analysis and Modelling.
- Conducted JAD sessions, created Use Cases, work flows, screen shots and Power Point presentations for the Web Applications.
- Experience in reviewing all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations
- Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems. Proficient in writing advanced DML and DDL SQL Queries for Backend Testing to check and analyze data integrity and validation.
- In depth knowledge of SDLC and implementation of the Rational Unified Process (RUP) in all four phases of a project: Inception, Elaboration, Construction and Transition.
- The project transitioned from Jira to Agile Craft (Safe Agile) used Jira to write the stories and features.
- Utilized a fusion of industry knowledge and technical programming to provide executive management the development and implementation of interactive business tools, and strategic analysis, vital for use in mission-critical decision-making
- Conducting requirement gathering sessions, feasibility studies and Impact Analysis and organizing the software requirements in a structured way using Rational RequisitePro to track development.
- Experienced in writing and preparing Business Design Documents (BSD), Requirements Analysis Document (RAD), and Requirement Design Document (RDD), functional specifications, defining project plan and change requests.
- Created Unified Modeling Language UML Diagrams including Use Cases, Activity Charts, Sequence diagrams, Data Flow Diagrams and ER Diagrams using Rational Rose and MS-Visio thus defining the Business Process Model and Data Process Model.
- Experience in preparing documentation which is in compliance with 21 CFR Part 11, Medicare Part D requirements, HIPAA ANSI X12 Transaction sets, and in accordance with NCPDP National Council for Prescription Drug Programs Standards.
- Business Analyst - Business Processes Design and Integration - Requirements Management - Business Requirement Documentation (BRD) - Functional Specification - Gap Analysis - UML Diagrams (Activity, Sequence, Use Case Dataflow Diagram) - Wireframes and Prototypes - Unit Testing, Functional Testing, Integration Testing, UAT, Defect Resolution - Sprint Planning, Sprint Retrospective, Sprint Daily Meeting - Data Mapping, Data Migration –Data Analysis, Data Validation – SQL Query – Implementation Methodology- SDLC, RAD, RUP, Agile, Waterfall.
Confidential, Ocala, FL
Sr. Business Analyst
- Interviewed Business Users to gather Requirements and analyzed the feasibility of their needs by coordinating with the project manager and technical lead.
- Thoroughly studied the requirements for the process re-engineering. Gathered requirements and modeled the data warehouse and the underlying transactional database
- Create and maintain data model/architecture standards, including master data management (MDM)
- Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
- Designed the business requirement collection approach based on the project scope and SDLC Methodology.
- Developed SQL Queries and stored procedures to fetch complex data from different tables in remote databases using joins, database linked servers and formatted the results into reports. Interacted with users for verifying User Requirements, managing Change Control Process, updating existing Documentation
- Developed the project by RUP methodology. Performed gap analysis. Designed flexible project foundation enabling rapid implementation of e-commerce website capabilities
- Review of promotional materials as per the Label specifications compliance with GxP GLP, GCP, GMP, GDP FDA Compliance Regulations.
- Conducted User Acceptance Testing for Business Objects Reporting for eQRMS GxP Reports, GxPChange Control
- Worked on requirement for AEM integration with Adobe Test and Target for Confidential’s first online store joefresh.com.
- Reported results with multivariate pivot-table and crosstab analysis and assembly reports, Excel exports, Excel charts, pivot tables. Vlookup, Hlookup. Data imports
- Created Activity Diagrams, Sequence Diagrams and ER Diagrams. Prepared and documented System Requirements and workflows for Content Management Application tool.
- Created relationships in Requirement Traceability Matrix linking Business Requirements to Functional requirements and Functional Requirements to Systems Requirements.
- Conducted Joint Application Development (JAD) sessions with IT groups. Identified the Key Changes, and participated in Stakeholder Management to communicate effectively with them
- Developed and Documented timelines for Project Delivery, and managed Projects and Resources to successful completion.
- Prepared graphical depictions of Use Cases, Use Case Diagrams, State Diagrams, Activity Diagrams, Sequence Diagrams, Component Based Diagrams, and Collateral Diagrams and creation of technical design (UI screen) using Microsoft Visio.
- Assisted to develop the Test Plan, Test Cases and Test Scenarios to be used in testing based on Business Requirements, technical specifications and/or product knowledge.
Confidential, Cambridge, MA
- Analyzed Inbound and Outbound file layout in Facets delimited keyword format and successfully design and developed technical requirements.
- Knowledge of several functionality available in the Facets several applications such as Billing, Member/Subscriber, Accounting, and Utilization Managements (UM).
- Troubleshoot any problems found when testing the SQL data database while validating the business rule.
- Updated Detail Level Requirement Document with client’s newly demanded requirements and Assisted Project Manager to create Change Request document.
- Document Requirement & conducting requirements walk-through with the Business to ensure that all their needs are met and gathered.
- Created well-defined business vision documents, business glossaries and requirements management plan as per the Agile Methodology.
- 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
- Creation of a Gap/Impact Analysis Document for changes of the EDI Transactions 837, 835, 276/277, 270/271
- Involved in impact analysis of HIPAA 5010 835 and 837P transaction sets on different systems
- Analyzed, and built an Enterprise Information Model consisting of Primary Subject Areas which will be utilized to identify and prioritize Data Quality and Master Data Entities, Metadata classifications and nomenclature, and Data Integration Roadmap.
- Documented requirements associated change requests with requirements and connected requirements with Use cases.
- Incorporated Rational Unified Process (RUP) to create Requirement Document Specifications using Visible Analyst.
- Performed extensive data modelling to differentiate between the OLTP and Data Warehouse data models
- Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
- Designed new reports and also improvements to existing ones. Coordinated lean events for process improvements. Prepared process flow/activity diagram for existing system using MS Visio and re-engineer the design based on business requirements.
- Involved in preparing project plans and identifying major milestones for each stage as per the SDLC model (RUP Methodology).
- Implemented the HIPAA privacy and security regulations to enhance the capabilities of the systems to process new products.
Confidential, Miami, FL
- Interact with school principals, teachers, tutors, tuition owners, parents, and students to gather requirements.
- Conducted brainstorming sessions with product owners to discuss the business requirements.
- Prepare detail Business Requirement Document(BRD) for each major module with process flow, process steps.
- Documented UML diagrams like (State Chart, Sequence, Use Case and Activity) for functional documentation.
- Followed Agile (Scrum) methodology through out the application development and actively participated in scrum planning meetings and estimation meetings
- Created and maintained User Stories by interviewing, brainstorming, one-to-one meeting with the business users to communicate the requirements to development and testing teams.
- Worked on receiving Encounter files from their PBM (Pharmacy Benefit Manager), verifying the data content by transactional analysis. Used ISI Toolbox Pharma Edition efficiently for FDA submissions.
- Converted EDM business initiatives into multi-year data management plan for this leading maker of biomedical devices.
- Establish the product backlogs and worked with the product owners to ensure feature-level user stories are prioritized and accurately documented.
- Proficiently helped development teams to break down large user stories for execution. Instigated in various Walk-through sessions with developers and provided presentations to help them understand the end user needs.
- Assisted Testing teams to build test plans and involved in Progression testing and Regression testing. Approved test cases for requirement verification and to check the functionality of the application.
- Author detail functional requirement document with screen layout, business logic, screen design, navigation flow, high level solution design.
- Perform UAT, functional unit testing, technical unit testing, integration testing using different browsers, platforms and for both website as well as android app.
- Maintain defect log and work with developers to prioritize the defect resolution, retesting and closing defects
- Helped marketing in preparing training documentation, work instructions, quick reference guides, training videos, presentations with product features and details.
- Involved in post-production activities like creating the Sign-off documents and customer trainings when necessary.
- Analyze all internal and external business requirements and provide detail specification to the developers based on CTMS
- Assured that all validation documentation such as IQ’s, PQ’s, Process Validation, Cleaning Validation, and Software Validation are in compliance with eCTMS
- Coordinated and documented all activities related to writing and editing user help manual for use in clinical trials
- Worked closely with Subject Matter Experts(SMEs) to help create project requirement document (PRDs), Functional Specification Document (FSD) and use cases
- Collaborates with the Medical Director(s) and business associates (e.g., healthcare plan, PBM, consultants) to define the best approaches to find areas for improvement and trend mitigations
- Working to gather Requirements for migrating of Content from Portal to Adobe AEM and functionalities including Multi-site management and multi-channel management and Digital Asset Management.
- Interviewing area experts, asking detailed questions and carefully recording the requirements in a format that can be reviewed and understood by both business people and technical people.
- Demonstrated understanding of project and corporate SOPs by producing work in compliance with SOPs
- Developed software requirements specifications that captured the software requirements for the complete system and serve as the “build-to” specification for development
- Serve as primary liaison between the technical team and the product team and end-users for the purpose of establishing a common understanding of requirements and the as-built product
- Prepared data flow (DFDs) and sequence diagrams for current and future state. Created test case scenario documentation and test cases; monitored output and quality of results. Conducted User Acceptance Testing (UAT) and consulted with technical team.