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Business Analysis Resume

Warren, NJ

Skill Set: Business analysis, change management, client relationships, disaster recovery, integrated learning support, project management, SDLC methodology/documentation, quality assurance (ISO CMM Level 5), risk management, UAT, usability engineering, validation (EU / FDA / ISO / SOX), vendor management, workflow management

Expertise:

AE, ATM. CAPA, CRM, DAM, dashboard, defect-tracking, EDM, ERP, ETL, Frame Relay, IP, infrastructure/connectivity, MOM, requirement-management, SDH, SONET, VOIP, wireless,

Work Experience

Jan. 2008 - present: Confidential, Whitehouse Station, NJ.

Role: PROGRAM MANAGER/BUSINESS ANALYST.

Responsibilities: Partner with solution architect and global users to determine solution; gather green-field business requirements, develop functional requirements for Global Medical Affairs: medical-legal review/submission/reporting, expert engagement/payment legacy systems pending SAP ERP/Siebel MRM and portal implementation and Global Marketing Communications promotional asset tool; draft project/test plan, traceability matrix, conduct user-acceptance testing, facilitate change management (SDLC). Systems/Tools: Aprimo, Cognos,Documentum, Microsoft Project Management, North-Plains Telescope,Remedy, Siebel MRM/Pharma, Team Site, TIBCO Business Studio BPM, Visio

Jan. 2007 - Feb. 2008: Confidential, Raritan, NJ.

Role: PROGRAM MANAGER/BUSINESS ANALYST.

Responsibilities: Manage data migration and off-shore application development and enhancements to a proprietary global Web-based pharmacovigilance (drug safety) system in a validated environment; work with US and EMEA users to gather region-specific business/functional requirements; develop project plan/schedule, functional requirements, design specifications, use cases, release plan. test plan, test cases, test summary report; test enhancements; design application Web pages and regulatory reports; review validation qualifications and SOPs; oversee change-management process. Tools: Actuate,Documentum, Mercury IT Governance, Microsoft Project Management, Remedy, Trackwise, Visio

May 2006 - Dec. 2006:Confidential, Whitehouse Station, NJ.

Role: PROGRAM MANAGER/BUSINESS ANALYST.

Responsibilities: Managed off-site application and infrastructure development and enhancements to global clinical trials tracking system and Site Builder Web sites and G2 Single-Identity Remote Access portal; gathered green-field business requirements; developed project plan/schedule, use cases, functional requirements, design specifications, test plans, test cases, traceability matrix, facilitated change management prepared summary reports; developed global SOPs (SDLC). Tools: ClearQuest, Documentum, Inform, Mercury Test Director, Mime, SQL, Team Site, Visio

Jan. 2005 - May 2006: Confidential, Monmouth Junction, NJ.

Role: PROGRAM MANAGER/BUSINESS ANALYST.

Responsibilities: Partnered with solution architect and global users to determine solution; drafted project plan/schedule, gathered best-of-breed business requirements, developed functional/design requirements for an SAP ERP implementation and remediation/integration involving 173 .Net/VB-Oracle/Lawson/Randstad/Controller Plus/AS400/MFGPRO/EDI/Galt/Sales Force
Automation legacy applications and 279 data interfaces in a validated environment; developed use cases, test plan, test cases, test summary, globalized training material; executed test cases; delivered instructor-led training; ensured ISO/Sarbanes-Oxley/EU
compliance and change management procedures (SDLC). Tools:SQL, Mercury Test Director, Mercury IT Governance, TrackWise, Visio

July 2004-Jan. 2005: Confidential, Murray Hills, NJ.

Role: PROGRAM MANAGER/BUSINESS ANALYST/SOFTWARE QUALITY ASSURANCEfor J.D. Edwards One World implementation.

Responsibilities: Drafted project plan/schedule, developed Sarbanes-Oxley/21 CFR Part 11/820 -compliant qualifications; reviewed test results, change requests, protocol results; developed use cases, policies/procedures/work instructions for J.D. Edwards One World with MES bolt-on (LDAP authentication) and MFGPRO ERPs, mainframe applications (including AS400), and infrastructure/middleware. Tools: QUMAS DocCompliance, TrackWise

Jan.-July 2004: Confidential, Bridgewater, NJ.

Role:PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.

Responsibilities: Drafted project plan/schedule, gathered best-of-breed business requirements; conducted risk analyses; developed use cases, traceability and roles/permission matrices, and Sarbanes-Oxley/21 CFR Part 11/PDMA-compliant qualifications and SOPs for Great Plains ERP (financial/manufacturing/purchasing/inventory/sales modules; LDAP authentication) with MES bolt-on (Merit Life Sciences), Crystal reports/Oracle, production/Citrix/Veritas backup servers, standard infrastructure/middleware; developed data migration and retirement plans for MFGPRO, and security guidelines, and SOPs for NuGenesis and Web-enabled RAS VPN/SecurID; reviewed NuGenesis and DataCeutics qualifications. Tools: BridgeTrack, SQL, QUMAS DocCompliance, Visio

2003-04: Confidential, Raritan, NJ.

Role:PROGRAM MANAGER/BUSINESS ANALYST.

Responsibilities: Conducted front-end analysis to assess varied needs of 209 operating companies; developed use cases; and gathered best-of-breed requirements for four-region, worldwide remote-access portal incorporating VPN//PKI token/iPass security/encryption technologies; developed 21 CFR Part 11/HIPPA/PDMA-compliant qualifications, traceability and roles/permission matrices;developed/globalized integrated learning support (user/SA/OAM/Help Desk guides); managed/developed/reviewed SOPs and training videos; developed/globalized e-Portal content.Tools: Documentum, TrackWise, Visio

2002-03: Confidential, Hopewell, NJ.

Role:BUSINESS ANALYST/VALIDATION ENGINEER.

Responsibilities: Modeled business processes; conducted front-end analysis to assess corporatewide needs; developed use cases and functional requirements for international deployment of Remedy client and Web-based Administration (LDAP authentication), Help Desk, Change Control (tracking), Reporting, Asset, Contact, SLA Management modules and ARGIS Asset Management/Documentum CoreDossier/SAP/Dendrite Sales Force Automation interfaces, and infrastructure/middleware; in compliance with cGXP, developed 21 CFR Part 11/HIPPA/PDMA-compliant traceability and roles/permission matrices, qualifications; reviewed SOPs; directed Web-based training and test script development,
managed user acceptance testing, gathered metrics, conducted root-cause analysis. Tools: Documentum, TrackWise, Visio

2001-02: Confidential, Raritan, NJ.

Role: PROGRAM MANAGER/BUSINESS ANALYST/.

Responsibilities: Drafted project plan/schedule; modeled business processes/network; conducted front-end analysis to assess needs of 209 operating companies; developed functional requirements for four-region, international Web-hosting network elements/applications—ATG Dynamo, Convera RetrievalWare, Documentum Web Content Management and CoreDossier, iPlanet, Resonate Commander—and Web-enabled bicorporate Remedy Help Desk; managed internal secure file transfer validation; worked with multiple organizations to develop and implement GXP- and FDA-compliant SOPs; conducted due diligence for external Web hosting; reviewed contracts/service-level agreements; drafted documents of understanding. Tools: Documentum, TrackWise, Visio

1989-2001:Confidential, Holmdel/Middletown/Piscataway, NJ/Karlsruhe, DR.

Role: PROJECT MANAGER/SYSTEM ENGINEER for In-Bound/Out Bound 800 Services, telephone cards, LAN/WAN wireless service and inventory-tracking systems, ATM/Frame Relay/IP/SDH/SONET/VOIP network-planning systems.

Responsibilities:Drafted project plans/schedules/test plans/test cases; developed system/GUI requirements/design specifications; managed MUT/PT/UAT cycles; conducted quality assurance audits (ISO 9000, CMM Level 5 compliance).

Education: Ph.D. Romance languages, AM mathematics, AB mathematics and economics

Certification: AT & T Bellcore Project Management

Languages: French, German, Italian, Portuguese, Spanish

Medical/Scientific Writing/Editing Projects
  • TKR Alternatives:Viscosupplementation with Hylan G-F 20 (Wyeth)
  • TKR: Local Adverse Events (Wyeth)
  • Berliner (ed.), Biological Magnet Resonance. Vol. 14: Spin Labeling: The Next Millennium (Plenum)
  • Schneer, Fundamentals of Ultrasonic Nondestructive Evaluation: A Modeling Approach (Plenum)
  • Thomas, Elliptic Cohomology (Plenum)
  • Svelto, Principles of Lasers, 4th ed.(Plenum)
  • DeFelice, Electrical Properties of Cells (Plenum)
  • Fujita and Godoy, Quantum Statistical Theory of Superconductivity (Plenum)
  • Poole and Owens, New Superconductors (Plenum)
  • Tirira et al., Forward Recoil Spectrometry (Plenum)
  • Lyons (ed.), Electroactive Polymer Electrochemistry, Part 2: Methods and Applications (Plenum)
  • Briggs (ed.), Advances in Acoustic Microscopy (Plenum)
  • Lyons (ed.), Electroactive Polymer Electrochemistry, Part 1: Fundamentals (Plenum)
  • Wang, Elastic and Inelastic Scattering in Electron Diffraction and Imaging (Plenum)
  • Burke and Joachain, Theory of Electron-Atom Collisions (Plenum)
  • Rochow and Tucker, Introduction to Microscopy (Plenum)
  • Russell (ed.), Experimental Mass Spectrometry (Plenum)
  • Thong, Electron Beam Testing Technology (Plenum)

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