SUMMARY:

• Experience of implementing a system to allow the International Consumer Products Group to maximize 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 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 all IS support and development of Clinical Trials.
• Strong project management skills (PMO / PM) in the application of SDLC methodologies (Waterfall, 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. Strong project management skills.
• Strong Global Management experience.
• Skilled in developed using Life Cycle Methodology (PMBOK Methodology) also skilled in budgeted estimation, a budget tracking, vendor and contract management.
• Sound knowledge of Project Management tools (MS Project Server, MS Project 2010, SharePoint, Word, Excel, PowerPoint, Outlook and Visio).
• Extensive IT Remediation experience.

TECHNICAL 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:

Confidential, NY

IT Project Manager Consultant

Responsibilities:

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

Confidential, Washington, PA

PMO / Senior Project Manager Consultant

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.

Confidential, Florham Park, NJ

IT Project Manager Applications / Infrastructure Consultant

Responsibilities:

• 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.
• Project 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.

Confidential, PA

IT Project Manager Consultant

Responsibilities:

• 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.

Confidential, PA

IT Program / Project Manager Applications Consultant

Responsibilities:

• 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.

Confidential, NJ

IT Project Manager Applications Consultant

Responsibilities:

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