PROFESSIONAL SUMMARY:

• 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

PRIMARY AREAS OF EXPERTISE INCLUDE:

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

SKILLS, AND AREAS OF FOCUS:

• 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)
• CDISC SDTM and ADaM
• CDISC SEND
• 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)

PROFESSIONAL EXPERIENCE:

Confidential, Princeton, NJ

Business Analyst/Product Development Lead

Responsibilities:

• 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

Responsibilities:

• 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

Responsibilities:

• 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

Responsibilities:

• 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