Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • Date of Birth:
  • India:
  • :
  • single:

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

  • Program management
  • Team building
  • Operational improvement
  • Communications
  • Project organization
  • Relationship development
  • Problem resolution
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


Activities and Honors
Project Management Certification Master Project Manager (MPM) American Academy of Project Management January 2011

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  • Director, Program Management, RA and R&D
  • Coordinator
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