Muhammad Saad Sultan

732-276-1866
[email protected]

Professional Summary:

 8+ years of professional experience as a Business/Systems Analyst in Pharmaceutical domain.

 Extensive experience in analyzing and requirements gathering and writing system functional specifications
including use cases.
 Expertise in Laboratory Information Management System (LIMS), Clinical Test Management
System(CTMS), Pharmaceutical lifecycle management (LCM)
 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
 Excellent in Developing and evalUATing business process Models.
 Effective in executing multiple tasks and assignments ahead of schedule. Created and maintained effective
budgets.
 Knowledge of Healthcare standard Health Level Seven (HL7).
 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 Information Technology capabilities and dependencies, including Platforms,
Content Management, E-Document strategies and Process Mapping.
 Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting
System (AERS), and Chromatography Data System (CDS). 
 Experienced in all phases of project management of IT and BPO including planning, project.cost analysis,
proposal development, procurement management, contract administration, project close out, profit and
loss responsibility, and account management. Strong understanding of project methodology (Waterfall,
Agile, Scrum) and knowledge of PMBOK Framework. 
 Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation. 
 Validation Laboratory Information Management System(LIMS) 
 Thorough knowledge of GRC regulation and policies
 Experience in Computer system validation using GAMP and GMP guidelines.
 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. 
 Investigated Impacts using GAP analysis due migration 1) FACET (Pharmacy Benefit Program) to Argus 2)
ICD-9 to ICD 10 HIPAA Conversion
 Good Exposure to Query Analyzer, Execution Plan to optimize SQL Queries.
 Initiated and lead GAP analysis with using Mercury Quality Center. 
 Strong experience in Healthcare Claims Processing and Healthcare NPI Implementation. 
 Strong experience with Test Case Management using Mercury Quality Center, Black-box testing, device
testing, integration testing, regression testing, User Approval Testing (UAT). 
 Clients, stakeholders and trading partners going over requirements, capturing action items and providing
appropriate solutions to complete associated tasks incurred. 
 Strong experience with Test Case Management

Education Details:Bachelor’s in Computer Sciencefrom Government College and University Faisalabad,

Pakistan 2010

------------------------------------------Professional Experience------------------------------------------------------------------------

Taro Pharmaceuticals USA Inc. Hawthorne, CA December 2018- Present

Sr. Business Analyst
For developing Taro’s business strategy with the goal of maximizing region profitability & performance.
Preparation of financial models & data analysis models in support of executive decision-making process &
development of company strategic initiatives, including identifying & making recommendations for streamlining
operational processes by implementing innovative statistical methods.
Responsibilities:
 Gathers requirements for the new Pharmacy Benefits Management system (PBM) from the Vendor Drug
as-is contracts documentation
 Worked with the account department, managements, and report requestors to gather requirements, get
report requests.
 Managed the whole process of reporting. Interacted in order to acquire the standards, record them, build
templates, and write specifications with the ETL team, developer(s), administrators, and account holders.
 Gathered business rules and requirements of different Lines of Business for the PBM process from various
key stakeholders of the company.
 Wrote Business Requirements Document (BRD), analyzed them and tested them.
 Gathered requirements by using interviews, requirement workshops and brainstorming and JADsessions.
 Designed report templates based on the requests by account managers.
 defining the Business Process Model and Data Process Model.
 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,
SAS and JMP 
 Involved with all the phases of Software Development Life Cycle (SDLC) methodologies throughout the
project life cycle.
 Served as conduit for managing system requirements between the business and the software development
team. 
 Queried database using SQL for backend testing
 Used Rational clear quest for defect management
 Involved in coordinating with the database design team, using SQL to Query databases and providing
inputs in finalizing the data model, report layouts.
 Prepared test plans, test cases & test scripts based on User Requirements Document (URD), Functional
Specification Documents (FSD) and Functional Requirement Document (FRD).
 Conducted acceptance tests to verify that the validation effort was complete
 Identified all risks associated with the project and gave suggestions for mitigating the impact the identified
risk posed to the business.
 Prepared UAT Materials UAT Test Cases to include various steps involved for UAT and to have proper
coverage of requirements.

Ovation.io, Cambridge, MA. January 2016-November 2018

Business System Analyst
I worked as Business System Analyst in Ovation to build the next generation of cloud based clinical informatics
tools for the genomic and molecular testing industry. The application provides an interface for users to browse the
drug repository located inside the DDMS. This system uses an extensive repository of drug information and
provides means for efficient dispensing and pricing of drugs in pharmacies.

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 a Business
Requirement Document (BRD) and Functional Requirements Document (FRD) and Software Requirements
Specifications (SRS). 
 Helped re-engineer FRD documents to differentiate clear and concise functional requirements from
software requirements. 
  Participated in the peer review process of FRD documents and other work products prior to client
submission. 
 Reviewed test case documents for multiple processes by researching and analyzing the finalized FRD
documents. 
 Conducted JAD and working sessions to discuss and prioritize requirements and resolve project related
issues. Actively involved in meetings with development team to discuss process flow and other
development issues. 
 Actively involved in walk-through and meetings with development team to discuss related issues.
 Interacted with users, developers, project manager and process analysts to understand the business
process, identify enhancements and gather business requirements. 
 Extensive Knowledge of HIPPA acts.
 Captured meeting minutes from requirement gathering sessions and additional client meetings and
documented the high-level discussion points, decisions and action items. 
 Assessed the status of the organization to determine the scope of the validation process.
 Gathered requirements by using interviews, requirement workshops and brainstorming sessions.
 Advised and helped web services team with designing, creative writing for the project. 
 Designed MDM integration plan and hub architecture for customers, products and vendors. 
 Presentation of results to stakeholders by conducting MDM workshops. . 
 Worked on various data formats using SAS Enterprise guide and created Web based reports using SAS Web
Report Studio.
 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

Boston Scientific, Marlborough, MA December 2016- January 2019

 Business Analyst
 I worked as a Business Analyst with Early Drug Development team validating the latest version
in LabWare LIMS. LabWare LIMS software is a complete laboratory information management system which aids in
sample tracking, laboratory processes, workflow, data access, storage and regulatory compliance issues. I was
responsible for Validation of individual Workstations and its linkage to laboratory equipment's using Empower. 
Responsibilities:
 Implement CTMS to centralize all trial-related information, and improve clinical data management by
equipping staff, including biostatisticians and database administrators
 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 of Labware LIMS and OpenLab 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 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 of Labware LIMS by 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.
 Developed Traceability Matrix matching URS and UAT for various release efforts for Labware LIMS.
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). 

Lablynx Corporation, Smyrna, Georgia December 2014 –October 2016

 Business Analyst
 I worked as a Validation Analyst / Business Analyst with Early Drug Development team validating the latest
version in LabWare LIMS. LabWare LIMS software is a complete laboratory information management system
which aids in sample tracking, laboratory processes, workflow, data access, storage and regulatory compliance
issues. I was responsible for Validation of individual Workstations and its linkage to laboratory equipment's using
Empower. . The project also involved interfacing lab instruments with the Labware LIMS 
Responsibilties
 Used ISI Toolbox Pharma Edition efficiently for FDA submissions.
 Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix
(RTM) to track requirements for the software application module. Validated LabWare LIMS to meet 21 CFR
Part 11 FDA Regulations.
 Created Validation plan for Laboratory Data system and Computer Systems (CDS, SDMS, ELN) interfaced
with LIMS. 
 Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation
and instrument validation activities.
 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 with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports. 
 Prepared specification documents for Labstation module of LIMS and created test scripts for positive,
negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab
Ware.
 Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile (Scrum).
 Involved in Functional, Positive, Negative, and Regression testing of Workstation/Equipment automation
with LIMS and Empower.
 Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
 Conducted project kick off meetings with team members to explain roles / responsibilities, relationships
with other groups, deliverables, timelines, assignments and status reporting.
 Prepare presentation slides in MS Project, which was extensively used in different JAD sessions and to
track progress.
 Developed Traceability Matrix matching URS and UAT for various release efforts for Labware LIMS.
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.
 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.
 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. Organized meetings to discuss outstanding
issues with QA and developers.
 Conducted acceptance tests to verify that the validation effort was complete