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Business Analyst/product Development Lead Resume

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Princeton, NJ


  • Life science professional with extensive experience in the healthcare and pharmaceutical sectors.
  • Analysis, modeling, and implementation of electronic healthcare standards
  • Electronic regulatory submission publication and assembly
  • Controlled health care terminologies/vocabularies and IDs
  • Laboratory instrumentation qualification and validation
  • Software Design
  • Software/Systems Development Lifecycle (SDLC)
  • Computerized System and Software Validation (CSV)
  • Regulatory Operations and Regulatory Affairs


  • 21 CFR Part 11/Data Integrity
  • Business Analysis (BA)
  • GxPs


  • 21 CFR Part 11/Data Integrity
  • Adobe Acrobat and associated tools/plug - ins
  • Analysis Data Reviewer’s Guide (ADRG)
  • Analytical Method Development
  • Annotated Case Report Form (aCRF)
  • Balsamiq
  • BMC Remedy
  • Briefing Book
  • CDISC CRT DDS (define.xml)
  • Computerized System Validation (CSV)
  • Controlled Vocabularies
  • DataFarm ezFormUtil
  • DataFarm ezPDFEnsemble
  • DataFarm ezQA
  • DocMaestro Infolinker
  • Documentum eCTD
  • EDMS
  • Electronic Regulatory Submissions
  • FDA Regulations/Guidances
  • First Doc
  • GAGEtrak
  • GC/FID
  • GC/MS
  • GC/NPD
  • GxPs
  • HL7 eStability
  • HL7 RPS
  • HL7 SPL
  • HP Quality Center
  • HPLC
  • ICH eCTD
  • ICH Guidance Documents
  • ISO IDMP (Identification of Medicinal Products)
  • Infodata Compose
  • ISI Toolbox
  • Laboratory Information Management Systems (LIMS)
  • Laboratory Instrumentation Validation
  • Legacy Data Conversion Plan & Report (LDCP&R)
  • MS Office Suite
  • Particle Sizing
  • PhUSE
  • Quantum Content Manager
  • Quantum Submission Manager
  • RACI Matrix
  • Registration Tracking
  • Request for Information (RFI)
  • Request for Proposal (RFP)
  • SAS Viewer
  • Sharepoint
  • Software Design
  • Software Development Lifecycle (SDLC)
  • Software Validation
  • Study Data Reviewer’s Guide (SDRG)
  • Study Data Standardization Plan (SDSP)


Confidential, Princeton, NJ

Business Analyst/Product Development Lead


  • Provided business and product management for development of Confidential ’s CONFORM lines of applications
  • Advised and consulted on industry best practices and trends in the development of validated clinical systems
  • Solicited requirements from internal SMEs for the development of new Confidential software products
  • Interpreted CDISC, FDA, PhUSE and other clinical data - related standards in order to generate requirements for the development of new Confidential software products
  • Participated in Product Development Leadership Meetings to drive company business strategy surrounding new product development
  • Participated as a team member on the PhUSE Define-XML 2.0 Completion Guidelines working group
  • Participated as a team member on the CDISC Metadata Submission Guideline (MSG) for SDTMIG v2.0 working group

Confidential, East Hanover, NJ

Business Analyst


  • Worked with client business SMEs to solicit requirements to create process documentation surrounding the authoring and submission of the following deliverables:
  • Analysis Data Reviewer’s Guide (ADRG)
  • Annotated Case Report Form (aCRF)
  • Briefing Book (BB) (Data Standards section(s))
  • Define.xml and Associated Datasets
  • Legacy Data Conversion Plan & Report (LDCP&R)
  • Study Data Reviewer’s Guide (SDRG)
  • Study Data Standardization Plan (SDSP)
  • Generated and reviewed process documentation. Typical deliverables included:
  • Document Authoring Templates
  • Document Authoring Guidelines
  • Document QC Checklists
  • Process Diagrams (e.g. swimlanes, flow charts, etc.)
  • Process Training Materials
  • Process Work Instructions\SOPs\Work Practices
  • Submission-ready Document Samples
  • Facilitated and coordinated the analysis and implementation of current industry electronic regulatory standards
  • Evaluated, improved and standardized client quality practices surrounding electronic regulatory submissions
  • Authored quality documentation to support and improve electronic preparation of regulatory submissions as defined by industry and Novartis requirements
  • Compliance Assessments
  • Compliance Plans
  • User Requirements Specifications
  • Technical Design Specifications
  • System Test Scripts
  • Trace Matrices
  • Test Protocols
  • User Acceptance Test Scripts
  • Work Instructions (End User, System Administrator, Technical User)
  • Training Materials (End User, System Administrator, Technical User)
  • System Management/Support Plans
  • Worked with program and project managers to manage internal business and IT expectations, project deliverables, and project team to ensure projects met objectives
  • Primary systems (projects) of focus during remediation effort included:
  • A supplier corrective action system used to track and manage supplier-related quality issues
  • A medical device inspection tracking system
  • A gage calibration and R&R study system
  • Supported dry run and formal execution of project test scripts
  • Provided quality/compliance guidance during authoring of testing deviations and discrepancies

Confidential, Berwyn, PA

Business Analyst


  • Developed and documented client’s business goals and Confidential ’s solution
  • Conducted interviews and group sessions to understand clients’ current working environment and business processes
  • Facilitated client sessions to map business processes
  • Designed and documented process requirements & definitions
  • Identified and documented areas for improvements through either system functionality or process reengineering
  • Mapped client business requirements to product functionality
  • Worked with client to outline and implement integration solutions
  • Configured software to satisfy client needs
  • Worked with product development team for system customizations/enhancements
  • Worked with PM to manage client expectations, project deliverables, and project team to ensure projects met objectives
  • Managed solution implementations
  • Collaborated with client to create standards and processes based on client-specific business needs and system functionality
  • Prepared standards and process documentation per Confidential 's best practices
  • Prepared work practice/process documents, prepared and delivered role-based training materials
  • Tracked issues & enhancements in OnTime software
  • Worked with Confidential ’s technical team members to liaise between clients & technology vendors to troubleshoot problems
  • Interacted with users, offshore developers, QA, project managers and product managers internally and externally
  • Worked as primary configurator of proposed Registration Tracker software

Confidential, PA

Business Analyst


  • Worked closely as an IT representative with Confidential business leads in different functions throughout Worldwide Regulatory Affairs to gather and refine requirements for a Global Electronic Regulatory Affairs Submission Planning and Tracking system
  • Worked closely with a third-party software developer in order to translate the Confidential business vision into a Global Electronic Regulatory Affairs Submission Planning and Tracking system
  • Developed Test Cases for User Acceptance Testing in HP Quality Center
  • Developed Test Specifications for User Acceptance Testing
  • Collected information for and reviewed the software developer's System Configuration
  • Regulatory submission data and metadata
  • Regulatory submission taxonomies and content plans
  • System security
  • Workflows and issues that facilitate the planning, management, and tracking of submission assembly activities
  • Reviewed Test Cases and Test Specifications developed by the Software Integration Testing team
  • Worked with the business team on the coordination and execution of informal (dry-run) testing
  • Authored and managed software change requests related to the Global Electronic Regulatory Affairs Submission Planning and Tracking system
  • Logged defects/bugs in HP Quality Center
  • Participated in regular defect/bug tracking, disposition, and resolution activities associated with the submission planning and tracking software
  • Generated regular defect/bug reports for use by upper management in project/business decisions
  • Routinely met with third-party software developer at their site to resolve project-related issues (e.g. defect resolution, testing clarifications, documentation editing, software enhancement requests, etc.).
  • Worked with Confidential 's internal IT team and the business on capturing requirements for formal Software Support Plans

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