Jewell Martin, MA, MBA, PMP, RAC

Staff Director for the newly created Office of New Drugs (OND) Executive Operations Staff. Responsible for hiring and managing staff and workload, creating new processes procedures for all activities under the OND Executive Operations purview.

Team Lead with primary responsibility of standing up the newly created Office of New Drugs (OND) Executive Operations Team by leading and managing a team of regulatory and business program managers. Worked with multidisciplinary teams which included, scientific, regulatory, and management professionals to network and build consensus on various projects across OND. Program management lead for 5 contracts that support priorities across OND. Contracts included Medical Editors and Writers, Industry Sponsor Meeting and Public Meeting and Symposia, IT Modernization and Project Management Contracts. Developed contract requirements and statements of work and monitored and track annual program budget and performance.

Senior Regulatory Health Project Manager in the Center for Drug Evaluation and Research (CDER), Office of New Drug (OND), Immediate Office, Regulatory Affairs Team. Serve as program manager of regulatory initiatives/program areas in conjunction with members of the Regulatory Affairs Team.

Product Quality Project Manager for pre-market and post-market programs. Function as the point of contact between industry and the FDA. Facilitate meetings between the agency and industry sponsors, manage activities of the review team, author correspondence, and monitor and report actual status of all activities within assigned projects.

Special Assistant to the Director for Clinical Management and Operations at the National Heart, Lung and Blood Institute. Independently manage special projects impacting institute clinical policy and standard operating procedures. Facilitate development and implementation of policies and standard operating procedures to support clinical studies by convening working groups across the institute. Supervise administrative support team by managing workload, providing feedback on performance, recommending training and approving attendance and leave. Developed leadership and management skills working alongside senior management within NIH and across HHS while completing the U.S. Department of Health and Human Services Emerging Leaders Program as 1 of 43 candidates in the class of 2009.

Managed relationships with vendors, manufacturers and biotechnology companies in contract negotiations Developed solutions for optimizing the research, planning and production of regulatory assays Awarded the FDA Commissioner’s Citation and Center for Veterinary Medicine (CVM) Honor Award