JOHN REVAITIS

acoibn@r.postjobfree.com

609-***-****

Senior IT Program / Project Manager (both Computer Applications and Infrastructure) with diversified

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information systems experience in developing progressive and innovative IT computer business solutions in both

Pharma and Consumer Products Industries.

Experience of implementing a system to allow the International Consumer Products Group to maximize

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revenue opportunities by effectively leveraging existing U. S. products to expand their worldwide presence by

automating the International Product Registration process.

Oversaw creation of project schedules: defining activities, durations, work break down structure, utilizing

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critical path analysis, estimating, planning and controlling the project costs to complete schedule activities.

Expertise in handling Consumer Product Divisions (domestic & international) (R&D) and responsible for

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all IS support and development of Clinical Trials.

Strong project management skills (PMO / PM) in the application of SDLC methodologies (Waterfall,

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PMBOK, Agile) in a matrix environment, providing constant up to date project meetings, MS Project Schedules

and meeting minutes with clients and all levels of individuals involved in the project.

Skilled in developed using Merck's Life Cycle Methodology (PMBOK Methodology) also skilled in

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budgeted estimation and budget tracking.

Sound knowledge of Project Management tools (MS Project Server, MS Project, SharePoint, Word,

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Excel, PowerPoint, Outlook and Visio).

BUSINESS SKILLS:

Extensive knowledge of Research & Development, Drug Discovery, Drug Safety, Drug Development, Regulatory,

Pharmacovigilance, IT SAS Drug Development, Regulatory Submissions (PSURS), Clinical Trials, Quality

Assurance, Manufacturing Plant Floor Automation (all levels of WIP), Production Planning, Production Scheduling,

Supply Chain Management, Procurement, Contract Manufacturing, Quality Assurance, Engineering, MRP, Cost

Accounting, Sales, EDI and Marketing, using both in house development and COTS implementations.

PROFESSIONAL EXPERIENCE:

Johnson & Johnson October 2012 to March 2014

November 2014 to Dec 2014

PMO / Senior Project Manager Consultant

Hired to establish a CDIT Program Management Office for Johnson and Johnson to assist in

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management of the IT projects involved in the agreed upon Consent Decree. Reported to PMO Manager (J&J)

and to assist in directing activities of the PMO. Ongoing day to day activities included overseeing 3 to 9

manufacturing and R&D MS Project Schedules involving 2 to 4 project managers .

Responsibilities:

Applied PMO management skills to devise and maintain a workable plan: covering initiation, scope

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definition, planning, governance, control, risk, issue, dependency management and effective project closure.

Maintained PMO processes, Project Server, and SharePoint.

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Balanced triangle of cost, scope and time to achieve project goals and realization of benefits.

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Collaborated with IT Project Managers to define and ensure total project quality in line with Consent

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Decree Guidelines.

Managed stakeholder expectations, delivering on requirements and building productive relationships.

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Project Risk, Issue and Dependency Management (Core Competency).

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Distinguished between risks (always in the future), issues/impediments (in the present) and

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dependencies and communicating this information clearly.

Oversaw creation of project schedules: defining activities, durations, work break down structure, utilizing

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critical path analysis, estimating, planning and controlling the project costs to complete schedule activities.

Decided how to approach, plan and execute risk and issue management activities over the course of a

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project: to manage both existing issues and dependencies and to reduce threat to project schedule and

objectives.

Conducted risk assessment (consulting the correct stakeholders) to identify risks that might affect the

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project, quantifying the levels of risk probability and severity/impact.

Novartis June 2011 to August 2012

IT Project Manager Applications / Infrastructure Consultant

Managed several projects with Project Engineers within Remedy (Change Management, Incident

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Management and Configuration Management) Project Budget (2.6 Million).

The project objective was to significantly improve the Onboarding Process of computer systems.

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Project Manager of a Proof of Concept project to show Remedy Change Management to demonstrate

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that with minimal customizations, Remedy’s functionality, audit ability, and scalability exceed GCM and ACMS.

Introduced a fully impacted change control process.

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Project Manager to implement bi directional incident case exchange with IBM Service Now (SaaS)

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and Remedy Incident Management (Incident Case Exchange) and also BT to get further transparency and

reduce the manual swiveling of incident tickets between Novartis and the Vendor systems.

Pfizer December 2009 to March 2011

IT Project Manager Consultant

Provided project plans of projects required to migrate Wyeth Legacy Clinical Systems to Pfizer Systems.

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Responsible for the scoping, planning, and execution utilizing standardized company Project

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Management Methodology (SDLC).

Successfully managed the day to day activities of projects through the project life cycle from initiation to

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closure including managing cross functional efforts such as requirements gathering, system analysis/ design,

development/configuration, testing and implementation phases.

Additional responsibilities and processes include cost, schedule, issues, risks, resource management,

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and status reporting of projects.

Functioned as the primary liaison between the business and the various IT teams.

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Merck July 2008 to April 2009

IT Program / Project Manager Consultant

Managed the implementation of a Safety Matters Topic Tracking System (Signal Detection).

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Responsible for an extensive review of SharePoint and Vendor software to determine requirements fit.

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The final system was developed working with Phase Forward's Lincoln Safety Group to include Merck's

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requirements regarding signal tracking in their Strategic Pharmacovigilance Empirica ™ Signal.

This was done through COTS implementation.

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The system provides Merck's Safety Matter Professionals with the tool to track signals, uncovering

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patterns and recognizing emerging trends in spontaneous event report data. Also was the Solution Manager on

this project.

The system was developed using Merck's Life Cycle Methodology (PMBOK and AGILE Methodology).

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Responsibilities during project development included:

Prepared Project Charter and reported project status to stakeholder management

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Created and tracked all elements of the project Work Breakdown Structure (WBS)

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Budgeted estimation and budget tracking.

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Offshore coordination during SharePoint evaluation.

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Created and submitted a Request for Proposal (RFP) for Vendor selection.

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Created project work plans including project roles and responsibilities across matrix organization.

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Managed day to day operational aspects of a project and scope.

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Reviewed deliverables prepared by team before passing to stakeholders.

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Effectively applied SLC methodology and enforces project standards.

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Identified potential risks and developed Risk Mitigation Strategy.

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Ensured project documents are complete, current, and stored appropriately.

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Coordinated day to day deployment activities with business and technical teams.

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Monitored deliverables against project schedule to ensure deadlines were met.

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Schering Plough Corp. May 1999 to September 2007

IT Project Manager Consultant

Global Medical Affairs : Reported to Pharmacovigilance Department during the 2 year assignment.

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Lead a team of 6 people for one year to identify, process and resubmitted all previously submitted

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Periodic Safety Reports (PSURs) to the Global Health Authorities (26 countries) required for Product

Registration.

Managed and prepared Adverse Drug Reaction information and Metrics for a new ADR Reporting

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System based on the Oracle Adverse Event Reporting System (AERS) a COTS System.

Responsible for tracking and reporting the status of all major Product Registration of Periodic and

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Aggregated Safety Reports on a weekly basis to the VP of Global Pharmacovigilance.

Tracked and handled Special Assignments for the Vice President of Global Pharmacovigilance.

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Identified, tracked and provided weekly status of GPV QC Improvements.

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Regulatory:

Managed the design, development and implementation of Electronic Copies for Documentation (ECOPS)

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using DOCUMENTUM (A COTS Records Management System). This was a joint effort between the IT, Clinical

and Regulatory Departments. Developed using all 7 phases of Waterfall SDLC. Managed all phases of testing

(UAT, SAT, IQ, OQ, Stress & Performance Testing).

Clinical:

Managed Phase Forwards COTS Clintrial System and Upgrades (Clintrial Migration). The task included

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an upgrade of the Clintrial System and a newer version of the Oracle Data Base.

Project Manager of the SAS Drug Development Department. Managed several SAS programmers within

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the Clinical Statistical Systems Support.

R&D Drug Discovery (Research Laboratories):

• Laboratory Information Management System (LIMS):

Managed the development implementation and budget tracking of Activity Base for the LIMS Bio Data

Management System BDMS (COTS). The Data Warehouse was created for the Chemotherapy and

Molecular Genetics Laboratories. Laboratory equipment and PCs were used to collect and enter

laboratory information into the system. The configuration was a UNIX client server / PC environment

using ORACLE Database. IS methodology (Waterfall SDLC and AGILE) were used to develop the

system. Completed and submitted a Request for Proposal (RFP) for this project A project prototype

was created initially prior to the production version.

• Assay and Drug Development:

Directed the design, development, implementation and budget tracking of a Robotic Quantitative High

Throughput Screening System (HTS). The system was developed using Visual Basic front end, Oracle

Data Base, and Crystal Reports in Client Server environment (HP UNIX / PC). The system was

developed using a formal “seven phase waterfall methodology” and an AGILE (prototype). Completed

and submitted a Request for Proposal (RFP) for this project.

Estee Lauder Corporation January 1998 to March 1999

IT Project Manager Consultant

Managed and directed the activities of the R&D I.S. project team.

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Directed the implementation of an R&D Formula Management System using Visual Basic, Oracle and

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Crystal Reports in a Client Server environment (UNIX / PC).

Defined the External Interfaces and Work Flows required to provide communication between the new

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R&D Formula Management System and existing product development systems.

Bristol Myers Squibb December 1987 to January 1994

IT Program / Project Manager

Responsible for three Consumer Product Divisions (domestic & international) (R&D) and responsible for

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all IS support and development of Clinical Trials.

Responsible for R&D Library Management (COTS) and Records Management (COTS).

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Completed a feasibility study to recommend Computer Assisted New Drug Applications (CANDA).

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Directed the implementation of an R&D Formula Management System (COTS) using Power Builder,

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Oracle Data Base.

I.S. Group Project Manager Systems Planning and Development

Managed and directed the activities of three I.S. project teams engaged in the design and

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implementation of large scale computer systems for Research & Development, Quality Assurance, Plant

Operations, Logistics, and Engineering.

Significantly Leveraged Business Accomplishments by enlisting and managing the use of COTS, Outside

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Vendors and Consultants.

Participated as a member of a four person team to establish SDLC Methodologies and implemented IS

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Development Standards & Guidelines.

Evaluated and recommended Imaging and COTS Document Management Systems.

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I.S. Project Manager, Manufacturing Systems

Responsible for the design, programming and implementation of a MRP System.

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I.S. Project Manager, Sales & Marketing Systems

Designed, managed and implemented Software to process and report Nielsen & Factory sales data.

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EDUCATION:

Bachelors of Science in Physics, Monmouth University, West Long Branch, NJ.

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Post Graduate Studies UCLA Los Angeles, CA

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