Kaushal Singh

743-208-9948
[email protected]

Professional Summary:
 A result oriented Business Analyst with 8+ years of experience in the Pharmaceutical industry with extensive
experience in requirement gathering for custom solutions in cross functional areas like pre - clinical research, clinical
research, Pharmacy Benefit Management, pharmaceuticals and bioinformatics.
 Extensive experience in analyzing and writing system functional specifications including use cases.
 Good experience of Veeva Vault (ETMF, CTMS, RIM Suite, Submission and Submission Archive).
 Broad knowledge of GxP (Pharmaceutical manufacturing, Biotech, Medical Devices and Life Sciences).
 Proficient in all the phases of System Development Life Cycle (SDLC) - Analysis, Design, Development, Testing
and Documentation of software applications.
 Exercised proficiency in eRequester & JIRA to monitor technical, infrastructure and service issues, as well as billing
issues.
 Proficient knowledge in executing Operational Qualification for various components of LabVantage LIMS by
utilizing in-house and vendor test scripts.
 Expert level understanding of project life cycle and SDLC and also RUP, RAD, Waterfall and Agile methodologies.
 Good experience in working with Clinical Trials Databases.
 Strong knowledge of Agile PLM, scrum processes and experience in redesign of product development process as per
the business requirement.
 Experienced on LIMS configuration, implementation, LIMS Master data, LabWare LIMS to meet site requirements.
 Expertise in Metadata Management, Data Profiling & Quality, Data Governance and Master Data management
(MDM).
 Experience in preparation of business requirement documents (BRD), Use cases, UML, Process Flows (BPM), Test
Plans, Test cases, Data Mapping etc.
 Experience in analysing of LIMS enhancements, troubleshooting issues, second tier application support and routine
master data configuration as required within the LabVantage LIMS application.
 Proven success as a business analyst through the years, providing a well-balanced understanding of business
relationships, business requirements, and technical solutions.
 Experience in Test Data reviewing and executing detailed Test scripts for UAT, analyzing bugs, interacting with
team members in fixing errors and User Acceptance Testing (UAT) and also assisted in post -production support.
 Strong understanding of information technology capabilities and dependencies, including platforms, content
management, e-document strategies and process mapping.
 Extensive experience in writing, reviewing and enhancing the validation deliverables (URS, FRS, Design document,
IQ, OQ, PQ) for LabWare LIMS.
 Proficiency in LabVantage architecture and functionality.
 Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical and Life Science Industries and cGMP, GCP,
GLP, CAPA, GRP.
 Extensive experience in coordinating the efforts, tracking and acting as the liaison between customer SME's,
management, development and supplier s on major PLM deployments.
 Comprehensive Experience in coordinating, drafting and executing efforts of MES-LIMS interface functional test
document involving SAP QM and LabWare LIMS.
 Excellent skills in forming and facilitating Joint Application Design (JAD) sessions for eliciting data requirements
that support the business requirements and documenting data flows.
 Comprehensive experience in Agile and RUP Business Process Modeling.
 Strong working knowledge of SDLC, GRC 21CFR Part 11 and software FDA validation practices.
 Proficient with data migration (ETL development), document data manipulation processes and scripts.
 Experience in Clinical Trial using SCRUM development methodology handling highly sensitive data.
 Extensive working knowledge in validating systems like Inventory management, LIMS, CMS and EDM.
 Proficient in Technical and Business Writings, Business Process Flow, Business Process Modeling, Business
Analysis and Testing various methodologies.
 Interacted with Business Unit members for gathering data, information and requirements related to enhancing
pharmacy claims and Medical, Lab and Radiology Reports.
  Excellent knowledge in developing and evaluating business process Models.
 Experience in validating Adverse Event Reporting System (AERS) and Chromatography Data System (CDS).
 Good Exposure to Query Analyzer, Execution Plan to optimize SQL Queries.
 Strong problem solving skills, troubleshooting L3 Production issues on Learning Management System and LMS
Data Mart & Reporting system.
 Proficient in MS Office Excel (pivot tables, vlookups, hlookups, macro), MS Access, MS PowerPoint, MS Visio.
 Proficient in developing and reviewing of various documents including the Software Requirement Specifications
(SRS), Standard Operating Procedures (SOP), Business requirements document (BRD), Use Case Specifications,
Functional Specifications (FSD), Systems Design Specification (SDS), Requirement Traceability Matrix (RTM) and
testing documents.
 Effective in executing multiple tasks and assignments ahead of schedule. Created and maintained effective budgets.
 Demonstrated ability to identify root causes of problems, consider both the long and short-term impact of proposed
solutions and develop workable solutions.
 Extensive Experience in Enterprise Document Management System EDMS with automated systems such as
Documentum and GXPharma.
 A Self starter with a positive attitude, willingness to learn new concepts and acceptance of challenges.

Work Experience

Tonix Pharmaceuticals - Chatham, NJ February 2021 – Till date

Sr. Business Analyst
The goal of the project is to implement a clinical data repository & a statistical computing environment. The repository
will be used to store & manage clinical data for Phase I trials from the different data sources like Rave, Oracle Clinicals,
etc. Business users of the project include statistical programmers, clinical scientists, and biostatisticians.

Responsibilities:
 Worked with business stakeholders to document business needs for the RFP package.
 Arranged meetings with the Client to understand the business requirements.
 Partnered with clients/scientists/technical groups to perform quality reviews on business requirements in order to
verify that the requirements accomplished the demands of the end users.
 Gathered and documented requirements for integration between Product Lifecycle Management (PLM) solution and
legacy system.
 Gathered requirement for Clinical Operation on Veeva Vault.
 Mapped the overall as-is business processes for each data source system in scope of the project.
 Involved in design and implementation of enhancements to GxP project within RIS (Radiologically Isolated
Syndrome) PreClinical department using LabWare LIMS, Watson LIMS and Crystal Reports.
 Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business
Process Modeling (BPM).
 Created procedures for Labware LIMS system and worked with Operations to implement.
 Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data
systems on day-to-day functions.
 Reviewed system validation documentation, including Validation Plans, Risks Assessments, Qualification Protocols
(IQ/OQ/PQ), URS/FRS, Test Scripts, Trace Matrix, and Final Summary Reports.
 Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in
accordance with 21CFR Part11 and Good Laboratory Practices.
 Created Source to target data mapping documents identifying key data elements and prepared Data Flow Diagrams.
 Participated in configuration of Labware LIMS and various lab applications for the Genetic Quality.
 Worked in formulating the test plan ensuring that the test matrix covers all the requirements, and validated the
expected results in systems testing.
 Executed UAT test cases for OBI using HPQC and Veeva system.
 Supported other team members to validate/qualify TrackWise, LIMS, ELN and Lab Equipments, etc.
 Worked on desiging, implementing and validating 21 CFR Part 11 compliance strategies for Labware LIMS.
 Worked with Data Warehouse in the development and execution of data conversion, data cleaning and
standardization strategies and plans as several small tables are combined into one single data repository system
MDM (Master Data Management).
  Worked in ETL environment involving Informatics/Data Stage and Business Intelligence tools like Cognos, Business
Objects. Initiated Requirement gathering, analyzing, validating, and authoring use cases usingUML.
 Involved in development of a structured change management approach and methodology with limited direction
 Created Process Flow diagrams, Use Case Diagrams, ER Diagrams, Class Diagrams and Interaction Diagrams using
Microsoft Visio and Rational Rose.
 Performed the requirement analysis, impact analysis and documented the requirements using Rational Requisite Pro.
 Documented validation transfer plans for four separate assays while collaborating with Marketing, R&D and
Manufacturing.
 Involved in mentoring specific projects in application of the new SDLC based on the Agile Process.
 Worked with the business consultants and Labware consultants to develop the complex LIMS reports for
environmental monitoring on CLS.
 Analyzing the ETL process created in Informatica, developed SQL queries and tables which replicated the ETL, and
compared the SQL results with the Informatica tables.
 Involved in creating business processes and modeling diagrams using Rational Unified Process (RUP).
 Initiated and facilitated successful project kick-off meetings for Change Management.
 Drafted 39 page policy paper about the importance of R&D, innovation and reimbursement levels for biologics.
 Worked under the guidance of the PMO Board, coordinated with various business units and departments (Chemistry,
Biology and Chromatography) and assisted in the procurement, selection, design and configuration of proposed
Laboratory Information Management System (LIMS) to ensure optimal operational performance.
 Documented various artifacts as per the FDA 21 CFR Part 11considerations as well as Good Manufacturing
Practices (GMP).
 Worked with key members from various cross-functional teams to analyse various third-party CRM solutions to
make a ‘buy vs. build’ decision. Conducted cost/benefit and impact analysis.
 Write notes and action items during corporate strategy meetings and monthly R&D, Internal & External Pipeline,
Generic, & Consolidated Finance meetings.
 Tested the interface workflow from the lab to AMS clinic after the change.
 Manage requirement definition & testing workshops with multiple vendors.
 Created targeted Questionnaires for SMEs to gather requirements.
 Served as a resource for analytical services utilizing SQL Server, and TOAD/Oracle.
 Responsible for gathering & understanding business requirements, design, development, testing and support for
Veeva Vault eTMF, Promomats, Medcomms.
 Run the SQL queries using TOAD and SQL Navigator.
 Involved in defining scope and creating project baselines for the Change Management Component.
 Created traceability matrix to ensure that the requirements are traced to the test cases.
 Ensured that extremely thorough, effective and organized test process is implemented and delivered the highest
quality product.
 Worked closely with the project team in planning, coordinating and implemented QA methodology on various
phases of the application.
 Analyzed results of Regression Testing as performed by Testers using QTP and held meetings with Developers and
Testers.
 Involved in implementation of Learning Management System (LMS), estimated effort based on the requirements,
and followed all effective SDLC processes for its customization.
 Interacted with the developers to report and track bugs using Test Director.

Regeneron Pharmaceuticals - Tarrytown, NY November 2018 – January 2021

Sr. Business Analyst
As a Business Analyst, I worked on Integrated Drug Information System. This Application was designed to store drug
information data in to database, which was made particularly for Pharmaceutical Companies. Other features of this
application include maintaining records for drug availability from a variety of manufacturers, interacting with other
distributors/companies and providing efficient dispensing and pricing etc. Periodic reports were also generated by the
application for various levels of management for decision and control purposes. The integration project used an extensive
repository of drug information and provided means for efficient dispensing and pricing of drugs in pharmacies.

Responsibilities:
 Created a Traceability Matrix to maintain the Traceability of the requirements.
 Served as a team interface for business interaction and responsible for proper channeling of their requirements to
match organizational capabilities and ensuring client satisfaction along with an end to end understanding of
Processes for Clinical Trial legacy Systems.
 Conducted user interviews, gathered Requirements, analyzed the Requirements and managed changes using Rational
Suite.
 Configured laboratory information management systems, such as LabVantage SQL LIMS,developing validation
master plans and validating LIMS implementations.
 Worked with the Master Data Maintenance teams to maintain multiple sets of supply chain master data (SAP).
 Worked with Data Warehouse in the development and execution of data conversion, data cleaning and
standardization strategies and plans as several small tables are combined into one single data repository system
MDM (Master Data Management).
 Recommended LabVantage LIMS as a Global solution to address analytics and help reduce the amount of time and
errors with the manual entry of assets and inventory management data into the new system to support web, desktop
and mobile development.
 Applied the concepts of Business Process Engineering (BPE) and Business Process Reengineering (BPR) to enhance
the auditing process.
 Prepared and updated Requirements Specification documents, Traceability Matrix, IQ scripts and OQ scripts as per
the Regeneron guidelines to be in compliant with FDA regulations.
 Conducted interviews with end-users to collect requirement and business process information.
 Implemented data access, storage and validation routines on the database server using Procedural
Language/Structured Query Language (PL/SQL).
 Developed business process models in RUP to document existing and future business processes.
 Researched and revised documentation in various formats for client’s Liquid Chromatographs (LC) and
Mass Spectrometers (MS) systems.
 Prepared and documented System Requirements and workflows for the Content Management Application tool.
 Performed extensive Requirement Analysis including data analysis and gap analysis.
 Validate the Chemistry Laboratory Information Management System (LIMS) for compliance with FDA regulations.
 Created user stories, test scripts and reviewed test results within JIRA.
 Designed project document templates based on SDLC methodology.
 Used JAD sessions and one-on-one meetings to identify Business and System Requirements and documented then
using Use Case Modeling, Process Flow diagrams and documentation, data mapping rules, and Screen mock-ups.
 Participated in various stages of data and requirement analysis for project needs.
 Identified internal and external system requirements, design and configuration set-up, also created User
Documentation and conducted training classes.
 Developed business requirement specification documents as well as high-level project plan.
 Performed daily support for the customized LIMS for bug fix and enhancement request.
 Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams and OOD using UML. Documented and
delivered Functional Specification Document to the project team.
 Reviewed User Requirements to create Validation Plan and define the validation strategy, Roles and Responsibilities
and all deliverables required for Validation of LabVantage LIMS.
 Assumed ownership of Use Case Diagrams, Use Case narratives and other various artifacts.
 Coordinated various kinds of User Acceptance Testing (UAT) including regression testing, system testing,
integration testing, functional testing, alpha & beta testing.
 Relieved pressure off the PM by maintaining artifacts and portions of the project binder.
 Worked with the Project Manager to develop both high-level and detailed application architecture to meet user
requests and business needs.
 Involved in PLM integrations like performing delivery, legacy data analysis, cleansing, mapping and migration.
 Participated in the logical and physical design sessions, assisted and developed high and low level design documents.
 Worked with the Project Manager in performing Risk Assessment, Management and Mitigation.
 Define and design the Data Acquisition, Transformation, and Data Cleansing approach for the MDM
implementation.
 Worked with user testing of systems, developing and maintaining quality procedures, and ensuring that appropriate
documentation is in place.
 Documented business and technical requirements gathering for the development of MDM, Data Warehousing and
Reporting implementation roadmaps.
 Performed task decomposition, delegated tasks and monitored project milestones using MS Project. Data mapping,
logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle
database.

Vertex Pharmaceuticals - Boston, MA May 2017 – October 2018

Business Analyst
The project involved interfacing lab instruments with the LabWare LIMS. I was responsible for Validation of individual
Workstations and its linkage to laboratory equipments using Empower.

Responsibilities:
 Gathered requirements by conducting meetings and brainstorming sessions with end users and SME and document
them using Requisite Pro - the documentation tool offered by Rational.
 Extensively involved in data modeling.
 Worked with project managers and assisted with the implementation of the LIMS software in compliance with the
FDA 21 CFR Part 11 requirements, using GAMP guidelines.
 Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data
within the Oracle database.
 Gathered requirements and modeled the data warehouse and the underlying transactional database.
 Involved in development of Clinical Trial Management System (CTMS) integrated with EMR and customized to suit
protocols following CDISC, GCP and other FDA standards.
 Validated LabWare LIMS to meet 21 CFR Part 11 FDA Regulations.
 Performed Gap Analysis of the processes to identify and validate requirements.
 Understand the As Is system and the To Be system concept and also prepared the System Process Maps.
 Prepared and analyzed AS IS and TO BE in the existing architecture and performed Gap Analysis.
 Created workflow scenarios, designed new process flows and documented the Business Process and various Business
Scenarios and activities of the Business from the conceptual to procedural level.
 Organize requirements into high level Use Cases and low level Use Case Specifications and modeled them into UC,
Activity and Sequence Diagrams using Rational Rose and MS Visio.
 Apply UML notations and methodology in developing models that accurately represent the business process and
workflows and clearly communicate them to the stakeholders.
 Evaluated and compared different potential solutions for laboratory data management.
 Facilitate JAD sessions involving the management, development and user teams for clarifying requirements and
facilitating better communication.
 Created and updated Validation Plan, Installation Qualification IQ Protocol, Operation Qualification OQ Protocol,
Performance Qualification PQ Protocol, Test Scripts, System Testing Summary, User Acceptance Testing UAT
Summary, Traceability Matrix and Validation Summary to assure user requirements and functional requirements are
satisfied in the system.
 Coordinated with the Senior Management in the weekly reviews for the Change Management, Systems Turnover,
Distributed Turnover and IT Operations.
 Coordinate and prioritized outstanding defects and enhancement/system requests based on business requirements,
allowing sufficient time frame to ensure accuracy and consider deadlines
 Assured that all Artifacts are in compliance with corporate SDLC Policies and guidelines.
 Used the guidelines and artifacts of the Agile Methodology to strategize the Implementation of Change Management
in different iterations and phases of SDLC.
 Review the Test Plan developed by the testing team for testing the application.
 Worked with the QA personnel in the creation of Test Cases using Rational Test Manager.
 Involved in performing version control and defect tracking activities using Rational ClearCase and Rational
ClearQuest.

Takeda Pharmaceuticals - Lexington, MA January 2016 - April 2017

Business Analyst

Responsibilities:
 Gathered requirements by conducting meetings and brainstorming sessions with end users and SME and document
them using Requisite Pro.
 Wrote functional requirements for the company’s PBM software system.
 Performed UAT and exposure to User Certification Testing (UCT) and Operational Acceptance Testing (OAT).
 Extensively involved in data modeling Advisor to the criminal justice agencies stakeholders on the best practices.
 Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data
within the Oracle database.
 As part of CRM Activities, gathered client data, managed, tracked and analyzed this data to improve customer
relationships and targeted marketing campaigns and pricing along with Marketing Team.
 Converted EDM business initiatives into multi-year data management plan for this leading maker of biomedical
devices.
 Experienced in executing validation guidelines for testing the GMP, GCP, GLP sensitive transactions.
 Created the configuration document for custom setup for various user groups such as HR, marketing, R&D & sales,
research analyst & investigators.
 Assigned tasks among development team, monitored and tracked progress of project following Agile methodology.
 Create and maintain data model/architecture standards, including master data management (MDM).
 Gathered requirements and modeled the data warehouse and the underlying transactional database
 Perform Gap Analysis of the processes to identify and validate requirements.
 Gathered Business/Functional Requirements from Business/R&D Users.
 Created Data Stage jobs to extract, transform and load data into data warehouses from various sources like relational
databases, application systems, temp tables, flat files etc.
 Assisted in developing 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.
 Use Cases and other Process Flow Models were developed using Visio and Rational Rose
 Worked on the testing process using Mercury Interactive Test Management tool Quality Center.
 Organize requirements into high level Use Cases and low level Use Case Specifications and modeled them into Use
Case, Activity and Sequence Diagrams using Rational Rose and MS Visio.
 Gather final requirement and draft the BRD and Business Data Flow Diagrams.
 Responsible for the coordination of the quarterly Veeva Align project plan.
 Worked with IT and business areas to support Veeva enhancement requests, incidents and Service
Requests.
 Established traceability matrix using Rational Requisite Pro to trace completeness of requirements in different SDLC
stages.
 Defined Functional Test Cases, documented , Executed test scripts
 Review the Test Plan developed by the testing team for testing the application.
 Assist the QA personnel in the creation of Test Cases using Rational Test Manager.

Lexicon Pharmaceuticals - The Woodlands, TX October 2014 - December 2015

Business Analyst

Responsibilities:
 Worked with the account managers, managements, and report requestors to gather requirements, get report requests.
 Wrote Business Requirements, analyzed them and tested them.
 Interacted with the ETL team, developer(s), management, and account holders to get the requirements, document
them, design templates, and write specifications.
 Designed Functional Specification Documents for the reports.
 Analyzed trading partner specifications and created EDI mapping guidelines.
 Extensive use of Excel to create Functional Specification Documents & Templates.
 Designed the process flow diagrams for flow of information and report creation process.
 Conducted RAD sessions for the report users, requestors, and the developers.
 Documented all the changes in the initial templates and was responsible for Release Management.
 Coordinated with the developer, on day-to-day basis, during the development process.
 Prepared Need Analysis Documents of the requirements gathered through JAD sessions.
 Prepared and analyzed AS IS and TO BE in the existing architecture and performed Gap Analysis. Created workflow
scenarios, designed new process flows and documented the Business Process and various Business Scenarios and
activities of the Business from the conceptual to procedural level.
 Used MS Visio to create Flow diagrams and Use Case Diagrams.
 Created presentations explaining the entire report development process, while drawing a comparison between the
legacy & the new report.
 Created Test Scripts & Test Scenarios to check report content, layout and parameters.
 Tracked the defects in legacy reports as per account managers and end users. Compared the results and tracked the
differences in excel
 Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the
results with the actual report against the Data mart (Oracle).
 Worked with ETL team during the upload process.
 Helped with Data Mapping between the data mart and the Source Systems.
 Worked with SQL queries using MS Access for data manipulations.
 Worked as a liaison between the Business and Technology Department.
 Enhanced communication lines between executives, managers, and peers.