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Resume of CZW, PMP
Consultant

EXPERTISE AND SERVICES

Electronic Document Management, Regulatory Submissions, Expert Consultant
Expertise in program / project management, director, regulatory submissions, report publishing, electronic document management, SDLC, VLC, validation process, business process mapping, business systems requirements, functional / strategic analysis, financial analysis, financial forecasting, business case development, business process reengineering, web site design, human factors, customer relationship.

This consultant's experience includes management of project teams and their deliverables, dependencies, and risks, software development lifecycles and methodologies, including traditional phased-in approach (Phases and Quality gates), Agile programming and project management, prototyping, rapid application development for web and object-oriented apps.

Specialization includes financial analysis, development, and reporting of project and staffing estimates / actuals, ETC, EAC, EV, ROI, team leadership, document management and leadership of large-scale documentum projects, leading writing/requirements teams in producing quality documentation, validation activities and deliverables in regulated, GxP environments, certified in SEI's CMM Levels II and III.

Additional experience includes usability engineering and quality assurance testing, coordination, and facilitation, customer relationship management, client and user focus groups, customer surveys, liaison between clients / users and technical groups, trade show coordination and representation, international sales and marketing of high tech sports training and monitoring equipment

PRINCIPAL INDUSTRIES SERVED
Pharmaceutical, Health Care, Communications, Computer

EDUCATION
B.S., Geology

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing expertise in certified project management, business process mapping, electronic document management, regulatory submissions, validation process consulting, human factors consulting, business financial analysis, and related expertise to a wide variety of clients.

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Principal Consultant, computer consulting service

Delivered direct consulting services to clients. Networked and identified new business opportunities at client site. Contributed to responses to RFIs/RFPs for Management Consulting and Solution Services. Represented company to clients and at conferences. Participated in creation of firm's Life Science Validation and SDLC Methodologies.

Senior Project Manager, Dev-IT PMO, Novartis, NJ

Managed concurrent transnational projects for Novartis Pharma -- one project brought global Regulatory Affairs in compliance with new global Health Authority submissions standards by implementing third-party, eCTD submissions tool; second project globalized Clinical Doc Management through creation of a web-based indexing system for physically stored regulatory clinical documents; third project identified new global processes for departmental report publishing, and examined web-based rendering and publishing tools. Coordinated planning and implementation of software solutions. Developed and maintained budgets of $650,000/phase per project, schedules, and resources using MS Project and Lotus Notes/MS Excel financial reporting tools; performed financial and resource modeling and forecasting; created Mandates, SoWs, Task Orders. Provided project oversight and direction to multinational, cross-functional project teams comprised of internal and external IT and business resources. Coordinated vendor evaluations; participated in producing GxP validation documentation, including Validation Protocol, Validation Test Plan, IQs and OQs. Addressed status, issues, risks weekly with project teams; communicated and fostered strong relationships with client IT Management, Business Owners, and Steering Committees through PowerPoint presentations and project/budget dashboards.

GIT/RIS Senior Project Manager/Business Analyst (Consultant), SPRI Global Regulatory Affairs, Schering-Plough Corp., NJ

Managed business analysis teams focused on gathering user requirements for two parallel projects: the transnational replacement of the current Regulatory Affairs repository system and Health Registration system. Created and maintained PM documents, including Scope Statement, project plan, communications plan; communicated status and issues to business area and management. Actively contributed to identifying and reviewing business requirements; conducted global requirements gathering sessions with GRA stakeholders and future users. Performed risk and regulatory compliance (GxP and 21CFR Part 11) assessments. Fostered relationships between potential vendors, IT, and business area. Drafted RFP for Global Health Registration System Replacement, and coordinated global vendor evaluations. Managed project eRooms for document sharing and collaboration. Created project dashboards with MS Project Server for communicating project status and milestones.

Document Management Senior Project Manager (Consultant), Bristol-Myers Squibb Co., NJ

Provided organizational control of Application Services' Documentum docbases and projects. Reported to the Associate Director of the Performance Management group. Established governance and control standards to Documentum document repository (objective was to establish secure and controlled doc storage). Coordinated and provided program management oversight to organization-wide document migration effort to a central Documentum repository for over 100 applications and 400 projects in 10 departments; maintained project plan and weekly status. Coordinated and structured Documentum folders and files of AS Metric Reports, Service Levels, and Project Management Framework for community access via OneIM Community Plumtree portal. Developed SOPs and work instructions for validated and non-validated systems; maintained control documents in BMS-customized, IBM's (PWC) Controlled Document Management System. Designed training decks and facilitated training on organization's processes, including SDLC, PMF, and Document Management. Promoted and facilitated creation of application support guides as resource tools for application support, and as deliverables for transition-to-support implementation phase of SDLC. Produced organizational Metrics Reports using data derived from the validated Remedy service request system. Evaluated, tested, and recommended Documentum "eRoom" as virtual project team tool. Provided Documentum repository training to administrators, technical specialists, and managers. Coordinated large documentation effort, meeting aggressive schedule for US Meds Business Support department -- produced over 2000 pages of technical specifications (to the programming logic level) for 17 mainframe legacy, SAS, client-server, SAP modules and bolt-ons, and web-based applications, including Chargebacks, Vendor, Ariba, Manugistics, Sales & Marketing, etc. Established standards and guidelines for the document repository that allowed for reduction in head count, cross-training, and resolution time of Remedy service request tickets. Managed functional activity of contracted and employee tech writers. Acted as group's Documentum Group and Folder Administrator, and provided Documentum training to support specialists. Defined template, guidelines, and procedures for creation of production support guides that were later adopted by entire organization. Customized Visio flowchart master stencils and templates; designed over 1000 Visio flows. Received training for 21 CFR Part II Policy, Remedy Help Desk and Change Management.

Requirements Manager, AT&T Account, Computer Sciences Corporation (CSC), NJ

Managed requirements deliverables for process and enhancement projects for AT&T Consumer Services Rewards client/server application and AT&T Calling Card mainframe provisioning platform. Coordinated business and functional requirements workload of IT Requirements team members writing business/system requirements, SOPs, and system validation test cases. Redefined AT&T IT business and functional requirements processes and standard operating procedures to comply with CSC Methodology. Documented processes and technology as knowledge transfer deliverables for outsourced applications, which reduced training time during handover period. Coordinated and facilitated Customer Satisfaction Focus Groups involving all levels of AT&T client managers. Reported areas of process improvement to upper management, resulting in improved monthly scorecards (met all objectives prior to leaving company). Redefined and rewrote AT&T Process Requirements, Standard Operating Procedures, and system validation procedures based on CSC Catalyst Methodology.

Marketing and Brand Awareness Director, Adepta Sport Technologies, Inc., NJ

Created international brand awareness and visibility for small, entrepreneurial company. Coordinated content management and changes to web site; wrote and produced marketing materials and manuals; attended trade shows and handled print advertising. Sold products in-house, in the field, and at trade shows.

Requirements Manager/Lead Systems Engineer in Human Factors Engineering, AT&T, NJ

Saved millions of dollars by successfully leading IT requirements for Business and Consumer Services. Managed workload, time, cost, and reviews of IT business and system analysts to define, design, and write requirements and test cases for: new client\server applications, AT&T Rewards Account Servicing and AT&T Integrated Sales & Service (IS&S); re-engineering of AT&T Line Repair and Maintenance Service Order user interface using Siebel development package; re-engineering of mainframe work center application into a centralized Web and NT server application, resulting in savings of $3 million/year in AT&T's maintenance costs. Supervised prototyping and usability teams for IVR and telephony-based work center and switching systems applications on web, java, Windows 95, and NT platforms. Facilitated 15-person Requirements Management Process Action Team for Software Engineering Process Group (SEPG) to define and document application and organizational workflow and business processes for certification at SEI CMM Quality Assurance and Process Levels II and Level III. Passed all audits for certification, met all objectives. Defined Standard Operating Procedures, Quality Assurance and Usability test procedures. Facilitated product demos for sales support and at trade shows and. Coordinated Usability and User Acceptance testing and facilitated end-user training. Followed AT&T Software Development Framework Methodology.

Project Manager (Consultant), NEC, NJ

Provided direction to a development group for proving credibility of NEC's Eastern US division's ability to design using object-oriented development standards. Coordinated $1.5 -3 million project plans for user interface design, usability testing, and documentation -- met all objectives. Produced business and system domain requirements and designed user interface for a Unix User/Group Management application, and for the creation of a prototype that would automate microbrewery beer-making process. Coordinated usability and quality assurance testing for ease-of-use and intuitiveness of the software prototypes.

Project Manager/Documentation Specialist (Consultant), Bristol-Meyers Squibb, NJ

Reduced 90% of post-implementation questions about "Worldwide Packaging System" application. Led writing team to produce intuitive online help and to define requirements for improving navigation of the user interface. Wrote test cases and coordinated usability testing.

PROFESSIONAL REGISTRATION
Project Management Professional (PMP), 21 CFR Part 11, CMM Level III

PROFESSIONAL AFFILIATIONS
PMI
STC
DIA

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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