 Project Manager for a Global Medical Affairs Cvent Application which allows Attendees to enter their information into Congress and Speaker Programs. The system collects budget information, meeting information, attendee data and meeting metrics. Project Manager for a Demand Management System to harmonize intake process of the DADS group and improve prioritization of tasks and resource allocation.  Project Manager for a Time Tracking System to allow consultants to enter their time and projects each week establishing a consistent measurable process for quantifying TPC for cost and efficiency. Project Manager for Portfolio Management Systems managing the conversion of MS Project on premises to MS Project Online for Clinical, Regulatory and Operations projects to allow improved accuracy of data, drive automation and allow for better portfolio and program management. Project Manager for a Resource Management tool which captures employees, roles, departments, activities, and timelines. Project Manager for an Agile Appian project which allows Principal Investigators to enter data directly to site contact application allowing data quality, efficiency, and reduction of staff. Responsible for Vendor Management – Negotiation of Contracts, Purchase Orders, Processing Invoices Finance and Budget responsibilities managing combined budget over $6MM. Tools used include Changepoint, SharePoint, Smartsheets, Power Point, Word, Excel, etc.

 Project Manager for Laboratory Keytruda systems. Responsible for purchasing software and quotes from Vendors.  Managed multiple projects at one time, including Acronis, Genedata Expressionist, LINK Created Task Orders for Purchase Orders. Delivered Project status using Portfolio Central. Updated Forecast for Budget on a Monthly basis. Produced and updated Project Plans including SDLC documents and Technical activities. Communicated status to Senior Management and Customer Sponsor. Responsible for budget of $2 million. Met very tight deadlines with cross-functional teams in a fast-paced environment. Team Leadership, delegation and created project vision.  Communicated project progress to Sponsors and stakeholders.  Updated SharePoint with Monthly Metrics and Progress Reports. Responsible for Project meeting minutes and Action Items. Used MS Project to keep track of schedules and resources. Responsible for Risk mitigation plans Oversee planning and execution of multiple projects – small and medium sized projects Assist with the Validation for all projects for GxP, 21 CFR Part 11, etc. SharePoint use for Inventory and Use cases.

 Project Manager for R&D Medical Writing Team for Pain and Respiratory Categories. Worked with Vendor to achieve 60 manuscript publications with teams located in Singapore, Australia, United Kingdom, Switzerland, China and France. Responsible for budget of $3 million. Met very tight deadlines with cross-functional teams in a fast-paced environment. Developed and maintained global project timelines by integration of functional and local market timing plans.  Communicated project progress to Sponsors and stakeholders.  Updated SharePoint with Monthly Metrics and Progress Reports. Responsible for Project meeting minutes and Action Items. Used MS Project to keep track of schedules and resources.

 Project Management for an SAP ERP System including Procurement, Accounting, Order to Cash, Financial Reporting, Payments & Receivables, etc.  General Project management including Project progress Tracking, Task status tracking, Issue Resolution, Action Item follow-up and Completion, Deck preparation for workshops/meetings and facilitated communication with key stakeholders, etc. Worked closely with the Sr. Manager/PMO Lead, to communicate progress and manage actions, issues/risks and escalate as needed. Ensured application of program management standards and Company processes were followed. Established reliable PM processes and meeting cadence for the ERP deployments.  Implemented and maintained standard project management methodologies & tools. Used MS Project to keep track of schedules and resources.

 Veeva Systems - Project Management for a Marketing Communications Team that migrated their content management platform for Marketing Materials from Zinc to Veeva. The system is responsible for creating and holding documents for FDA Submissions.  Regulatory environment, GxP for a Pharmaceutical company.  Created Data Migration Plans and Scripts and the SDLC Documentation. Led the User Acceptance Testing and completion of UAT Scripts. Responsible Change Management and Process Change for the new system – scheduling and implementation.  Used MS Project to keep track of schedules and resources.

 Regulatory environment, GMP for a Manufacturing Site.  Project Management and Quality Management: The site was GMP and was closing so the company was retiring and archiving the GMP applications including SAP. Managed weekly team meetings, Steering Committee meetings, organized agendas, wrote and distributed minutes, etc. Risk / Change / Issue management: As the Project Manager, responsible for the creation and closure of all Issues, Changes and Risks. They were tracked in Clarity as well as SharePoint and communicated to the Project Team and Stakeholders.  Used MS Project to keep track of schedules and resources.

 Project Manager of a Chemical Management System – CMS – a GxP system with High Risk Systems Implementation GxP System – Regulatory environment. Methodology used was SDLC Waterfall. Project also included Vendor Management.  Project Leadership: Led the entire project process, including the creation and execution of deliverable-based project plans based on Project Management best practices (PMI). Project Management: Managed weekly team meetings, Steering Committee meetings, organized agendas, wrote and distributed minutes, etc. Project Tracking: Tracked the Document List, Requirements, designed the creation and training of new SOP’s. Also responsible for Change Management. Used MS Project to track all related project information. SharePoint: Updated and maintained the project SharePoint site.

* Working on Multiple Projects for the Security Area – Web Application Vulnerability Scanning, Enterprise Vulnerability Scanning, Intrusion and Detection Prevention Systems and Secure Email. * Project Leadership: Responsible for the definition, documentation and execution of the project, actively leading the team in all Phases of the project life-cycle using SDLC. Responsible for directing others in their work for the projects..* Project Execution: Identified and organized the required manpower resources for the project: assigning and communicating personal and team responsibilities, ensuring business goals are understood and achieved; Negotiates team member assignments with resource managers. * Project Planning: Effectively estimated costs, timescales and resource requirements for the successful delivery of the assigned phases of the project to an agreed scope. * Project Quality: Ensured that realistic project and quality plans are prepared, including: resource allocation for staff engaged on more than one project; inter-project dependencies; Architecture alignment, make recommendations/decisions on technical options as appropriate. * Project Budgeting: Created and tracked Capital and Expense budget for assigned projects. Creates Capital Requests.

• Collaborate with IT Project Managers, teams and business groups to ensure that IT systems are developed and managed in accordance with Quality and Compliance requirements.• Provided guidance in creating documentation to follow the SDLC methodology.• Assisted in authoring Functional Specifications, Test Plans, Test Scripts, Traceability Matrix and Test Summary Reports for over 30 projects.• Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes.• Follow SOPs and industry best practices.• Conduct training on good documentation and good testing practices.• Provide customers and stakeholder with confidence through Compliance education, risk management, audit hosting and through quality assurance and auditing.• Ensure that products and services are in compliance with appropriate quality and compliance related standards and that the organization maintains a state of audit readiness. • Led and Reviewed validation deliverables both in-house and third party suppliers.• Responsible for Reviews of all Software Development Lifecycle documents including Requirements, Test Plans, Data Migration Plans, Test Scripts, Traceability Matrix, Support Plan, etc.• Assess IT Quality and Compliance requirements through review and approval of IT documentation.• Author Compliance/Validation Summary Reports at the end of each project to ensure deliverables are in compliance.• Experience with GxP regulations and Good Documentation Practices. • Excellent Verbal and Communication skills and strong command over the English language, both written and spoken.• Detail oriented with excellent problem-solving skills.• Strong organization skills with an aptitude for documentation of processes and procedures.

SOX PMO for Merck (formerly Schering-Plough).• Program Manager and Senior Technical Advisor of SOX (Sarbanes-Oxley) PMO (Project Management Office). Manager and responsible for the entire SOX Testing for 150 applications and infrastructure systems. • Responsible for SAP Validation Support. Single point of contact for all SAP SOX issues and remediation.• Responsible for QC review of validation documentation, test plans and test scripts.• Responsible for auditing several Global locations including France, Italy, Portugal and the United Kingdom.• Managed the inventory, SOX Testing scheduling and allocation of resources.• Interfaced with the Deloitte external audit testers, explaining approach and strategy.• Maintained and updated the program Risk Control Matrix, Control Catalog and the inventory. • Ensured all remediation was accurate and completed in a timely manner.• Guided, developed and recommended compliance practices and procedures.• Liaison with the Finance SOX PMO on uniform objectives and testing approach.

• Manager and Senior Technical Advisor of SOX (Sarbanes-Oxley) PMO (Project Management Office). Manager and responsible for the entire SOX Testing for 150 applications and infrastructure systems. • Manage the inventory, SOX Testing scheduling and allocation of resources.• Interfaced with the D&T external audit testers. • Updated the program RCM, Control Catalog and the inventory. • Ensured all remediation was accurate and completed in a timely manner.• Utilized the tool Axentis to complete our goals and objectives for 2008 and 2009.• Consistently improve and enhance the Axentis tool for better results in deliverables and reporting• Liasion with the Finance SOX PMO on uniform objectives and testing approach.

Manager of Clinical Systems and development of COPD, Cardiovascular and Allergy studies.• Manager of CDAS, CCPF and PET for Regulatory and Compliance Systems - Regulatory and Compliance Systems Manager of a 10 person team for Clinical Documentation for submissions to the FDA. Responsible for implementing a $1.8 million project to upgrade the system for 21 CFR Part 11 remediation. This project focuses heavily on computer validation and GxP standards.• Manager of a CCPF (Customer-Centered Product Flow) application team responsible for developing an online system to accommodate the new CCPF work flow process using .Net technology. Achieved a very tight deadline with no budget by leveraging existing resources.• Sarbanes-Oxley Internal Auditor – Volunteered to work as an auditor for internal systems for Sarbanes-Oxley. Assessed internal systems for potential Sarbanes-Oxley gaps. Advised System Managers on how to remediate the findings in a timely manner. • Responsibilities include gathering requirements, technical guidance, task assignments, project tracking, issues management, implementation and conducting weekly status meetings with clients and senior management.

Manager for 4 years in charge of multiple departments involving Application Development for Portfolio Accounting, Optimization, 3rd Party Outsourcing (India, Philippines, NJ) and Y2K. Technology used was C++, Java, C, Perl, Unix, Sybase, Natural and Adabas.

Project Manager responsible for an Application Development team developing software for a Dealer Management System which controlled our Dealers who sold IBM equipment: PC’s, Printers, Software, Mid-Range, etc. Started as a Programmer and worked my way up to Senior Programmer, Analyst, Team Leader and Project Manager in the 8 years I was at IBM. Technology used was C, C++, Visual Basic, UNIX, SAS, PL/1, DB2, CSP, JCL, TSO, VSAM, etc.