JOHN REVAITIS

ac3t8e@r.postjobfree.com

609-***-****

US Citizen

Introduction

Over 20 yrs of experience in project management with diversified information system experience in developing innovative solutions in Pharma, Consumer Products and Medical Device industries both applications and infrastructure projects. Strong Global Management experience.

Project Management experience in companies like Merck, Bristol Myers Squibb, Schering Plough, Pfizer, Novartis, Johnson and Johnson, Church and Dwight, Becton Dickinson and Estee Lauder.

Strong project management skills (PMO / PM) in the application of SDLC methodologies(Waterfall, PMBOK, Agile Scrum), in a matrix environment, providing constant up-to-date project meetings, MSPS Project Schedules and meeting minutes with clients and all levels of individuals involved in the project.

Experienced in Project Management tools (MS Project Server, MSPS Project 2010, SharePoint, Word, Excel, PowerPoint, Outlook and Visio) and has created and tracked all elements of the project Work Breakdown Structure (WBS)

Summary

• Developed and maintained project control documents in accordance with enterprise project management methodologies, including: project charters, cost plans, capacity management plans, risk management plans, communications plans, governance plans, schedules, change management plans, knowledge management plans and quality assurance plans.

• Developed detailed project plans using project scheduling tools such as Microsoft Project and Project Scheduler.

• Lead all project plan development activities, including identification of phases, activities, tasks, deliverables, milestones, dependencies, schedules and assignment of resources

• Motivated project resources to complete assigned duties and tasks.

• Prepared formal reports on the status and health of the IT projects, including periodic status reports, management dashboards and project metrics.

• Monitored project quality, schedule and budget and facilitated actions to mitigate risk and address issues that arise. Skilled in budgeted estimation, budget tracking, vendor and contract management.

• Facilitated the risk and issue management processes for IT projects by maintaining risk and issue logs, identifying risks and issues, communicating issues and risks according to project governance and working with project team members to ensure effective risk and issue management.

• Facilitated deliverable and project artifact approval processes for IT projects by tracking all deliverables and project artifacts that require approvals, communicating the need for approvals to the appropriate groups and individuals and tracking approval decisions and following up where need be to ensure approvals are achieved within established timeframes.

• Managed the project change control process for issues that impact the quality, schedule or budget of the project by: documenting change requests, securing approval for changes and documenting approved changes in accordance to project governance.

• Facilitated periodic and ah-hoc project meetings, including scheduling with appropriate team members, preparing agendas, recording action items and key decisions and preparing, circulating and seeking approval for meeting minutes.

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:

Becton Dickinson Corporation

Franklin Lakes, NJ Nov 2016 to Dec 2017

IT Project Manager Consultant

Essential Duties:

Attend weekly planning meeting with cross functional teams

Prepared action items and meeting agenda and timelines.

Establish project deliverables by recording detailed stakeholder requirements, constraints, and assumptions.

Communicate program and project plans to ensure a common understanding by stakeholders and team members.

Assist with budget creation and manage the budgets.

Participated in cross-functional teams in support of continuous improvement and other management objectives.

Pentax Medical Corporation

Montvale, NJ June 2016 to Sept 2016

IT Program / Project Manager Consultant

Responsibilities:

•Manage project execution from concept to commercialization in adherence to the company’s quality procedures.

•Ensure project deliverables are properly managed in the quality management system.

•Successfully lead one of their projects using Agile Scrum .

•Lead cross functional project meetings including design reviews.

•Drive execution of projects and track tasks to assure projects are completed satisfactorily, on time and within budget.

•Understanding of hardware and software product development life-cycles .

•Manage departmental projects as defined by management.

Church and Dwight

Ewing Township, NJ Sep 2015 to Mar 2016

IT Program / Project Manager Consultant

Responsibilities:

SharePoint Update

Changed SharePoint text view to SharePoint Tile Icons & Office 356.. This was done for Human Resources and PMO department.

•Telephone & Conference Room Upgrade Mexico, Canada and England)

Estee Lauder Corporation

Millville, NY. Apr 2014 to May 2015

IT Project Manager Consultant

Responsibilities: .

Formula Management System

Prepared, managed and tracked a R&D Formula Management System using MS Project Schedule.

Defined the External Interfaces and Work Flows required to provide communication between the new R&D Formula Management System and existing product development systems.

Johnson & Johnson

Ft. Washington, PA October 2012 to March 2014

PMO / Senior Project Manager Consultant

Hired to establish a CDIT Program Management Office for Johnson and Johnson to assist in management of Application 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 MSPS Project Schedules involving 2 to 4 project managers. The Remediation Effort mandated that all projects were monitored under a high level of Quality Assurance. The Six Sigma philosophy was used in some of the projects analyzing results as a way to reduce defects in manufactured products.

Responsibilities:

Applied PMO management and Change Management skills to devise and maintain a workable plan: covering initiation, scope definition, planning, governance, control, risk, issue, dependency management and effective project closure.

Maintained PMO processes, MSPS Project Server, MS Project 2010 and SharePoint.

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

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

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

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

Distinguished between risks (always in the future), issues/impediments (in the present) and dependencies and communicating this information clearly.

Oversaw creation of project schedules: defining activities, durations, work break down structure, utilizing 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 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 project, quantifying the levels of risk probability and severity/impact.

Novartis

Florham Park,

IT Program / Project Manager Consultant Applications / Infrastructure

Managed several projects with Project Engineers within Remedy (Change Management, Incident Management and Configuration Management) for a Global Rollout. Project Budget (2.6 Million).

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

Manager of a Proof of Concept project to show Remedy Change Management to demonstrate that with minimal customizations, Remedy’s functionality, audit ability, and scalability exceed GCM and ACMS.

Introduced a fully impacted change control process.

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

Collegeville, PA. December 2009 to March 2011

IT Project Manager Consultant

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

Responsible for the scoping, planning, and execution utilizing standardized company Project Management Methodology (SDLC).

Successfully managed the day-to-day activities of projects through the project life cycle from initiation to 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, and status reporting of projects.

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

Merck

Lansdale, PA. July 2008 to April 2009

IT Program / Project Manager Applications Consultant

Drug Safety:

Managed the implementation of a Topic Tracking System (Developed with Phase Forward's Lincoln Safety Group).

The system provided Merck's Professionals with a tool to recognize emerging trends leading to commercial opportunities. The system also tracks signals and uncover patterns in spontaneous event report data.

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

The final system was developed working with Phase Forward's Lincoln Safety Group to include Merck's requirements regarding signal tracking in their Strategic Pharmacovigilance Empirica™ Signal.

This was done through COTS implementation.

The system was developed using Merck's Life Cycle Methodology.

Responsibilities during project development included:

Prepared Project Charter and reported project status to stakeholder management

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

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

Budgeted estimation and budget tracking.

Offshore coordination during SharePoint evaluation.

Supervised the creation of project requirements.

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

Solicited a gap analysis from vendors between their current software and the project requirements.

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

Reviewed deliverables prepared by team before passing to stakeholders.

Effectively applied SLC methodology and enforces project standards.

Identified potential risks and developed Risk Mitigation Strategy.

Retained issue list containing status and ownership responsibility.

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

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

Monitored deliverables against project schedule to ensure deadlines were met.

Merck (Legacy Schering Plough Corp.) May 1999 to March 2008

Springfield, NJ.

IT Project Manager Applications Consultant (9 years)

Drug Safety: (Remediation Effort to resubmit all product registration safety reports and replace the Adverse Event Reporting System).

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

Lead a team of 6 people for one year to identify, process and resubmitted all previously submitted 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 System based on new Oracle Adverse Event Reporting System (AERS) being installed.

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

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

Regulatory:

Managed the design, development and implementation of Electronic Copies for Documentation (ECOPS) using DOCUMENTUM which contained clinical documentation (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 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 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) 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 a prototype. Completed and submitted a Request for Proposal (RFP) for this project.

EDUCATION:

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

Post Graduate Studies UCLA Los Angeles, CA

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