Accomplished and ambitious Program Management professional with 15+ years of outstanding experience in leadership and management of global projects. I am a hardworking, highly organized self-starter, a detail-oriented team player with excellent written and verbal communication skills, a strong work ethic, professional demeanor, and the ability to work independently or as a team to meet project deadlines, on time and within budget
Skills
Program management
Team building
Operational improvement
Communications
Project organization
Relationship development
Problem resolution
Experience
Director, Program Management, RA and R&D, 06/2016 - Current Womack Machine Supply Co Of Ok – Houston, TX,
Direct activities on significantly large global programs and/or projects across multi-disciplinary roles
Develop and manage strong working relationships with partner functions such as IT, Finance, Business Development and Commercial Operations to ensure all milestones and deliverables are met
Address cross-functional issue/risk identification, documentation and mitigation planning
Develop and manage scorecards and dashboards for utilization by the projects level teams and as a reporting mechanism to Sr. Management
Act as a lead driver of project success, to facilitate the resolution of day-to-day business, technical and general project issues
Decide project leadership hierarchy, organization and status reporting relationships by reviewing project charters and ensuring compliance to determine timeframe, budgetary limitations, procedures for accomplishing projects, staffing requirements, and allotment of available resources to various project phases
Provide leadership and motivation to project team members throughout the project life cycle; mentor, coach and train others in program/project management best practices
Set performance objectives and incorporate feedback from team and organization for continuous improvement
Manage project teams of 5 to 15 cross-functional, multi-disciplinary project team professionals
Direct budgeting and forecasting activities for the Global Regulatory Affairs and Research and Development business units
Global Project Lead for large database redesign and restructure for the company’s regulatory database for regulatory status around the globe; coordinating feedback from SMEs in various regions around globe; interacting with development and business analysts to properly design and evaluate user requirements and testing structures for database integration; design training materials and provide input and feedback on such materials to provide to the multiple employees within the global organization
Global Project Lead and designer of the company’s portfolio rationalization program responsible for reviewing, evaluating and presenting proposals to withdraw marketing authorizations, across all global regions, the designated review and approval committees; responsible for coordinating, tracking and confirming final approval with the various Health Authorities for approved candidates, and reporting total return-on-investment for the program
Developed internal tracking mechanisms to ensure timely submission of required regulatory documents and follow-up with FDA
Lead and direct team meetings with US FDA, including presentations to FDA, drafting company meeting minutes and coordination of final meeting minute submissions to FDA
Lead and direct virtual and face-to-face product review and update meetings with personnel and Executive Management throughout the globe
Develop, review, edit and finalize policies, forms, SOPs and work guidelines associated with various global regulatory project management processes and projects
Design process/program for monitoring state rules/regulations regarding manufacturer, wholesaler and 3PL licenses to ensure compliance with such rules/regulations
Establish and maintain a tracking system for notifying Sr. Management and applicable stakeholders of changes in rules and regulations that may affect the current business process for obtaining and renewing state licenses
Prepare and submit notifications to states regarding Officer changes, changes in business descriptions, or other compliance requirements under each state’s licensing guidelines.
Coordinator, 04/2003 - 03/2009 Mylan Inc. – City, STATE,
Served as link between management and employees by handling questions, interpreting and administering contracts and helping resolve work-related problems
Partnered with peers and cross-functional teams to align operations with targets and strengthen internal relationships
Assembly and coordination of NDA and IND regulatory submissions to the health authority (US FDA)
Assembly, coordination, review and submission of NDA and IND annual reports to the health authority (US FDA)
Travel, meeting coordination, and presentation development for executive meetings both on-site and at remote locations.
Set-up of virtual meetings via video teleconference and via WebEx
Expense Report Processing, Budget analysis and SAP financial forecasting
Guidance tracking and interpretation for the Regulatory Department
Development and updating of organizational charts
Processing of POs and invoices through the SAP system
Promotion and coordination of legal contracts with vendors and suppliers through the LCM system
Manager, PDMA Sample Accountability, 06/2000 - 09/2001 Mylan Inc. – City, STATE,
Design and creation of a new department charged with compliance under the Prescription Drug Marketing Act for tracking and reporting of drug sample patterns of the organization’s outside sales representatives
Responsible for creating and establishing the appropriate SOPs, policies and procedures required to ensure the organization’s compliance under PDMA
Ensure compliance with DEA registration requirements for the physicians to which the representatives delivered drug samples
Management, training, and development of entire sample activity team, as well as training for sales representatives in the field
Reporting of thefts and losses to the appropriate authorities as identified in the organization’s compliance program for sample accountability
Monitoring, reconciliation and reporting of drug sample inventory for entire sales force.
Education and Training
Master of Science: Project Management, Expected in 03/2009 - COLORADO TECHNICAL UNIVERSITY - Colorado Springs, Colorado, GPA:
DEGREE WITH A CONCENTRATION IN PROJECT MANAGEMENT MAY
Activities and Honors
Certifications
Project Management Certification
Master Project Manager (MPM)
American Academy of Project Management
January 2011
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