The incumbent serves as the Director, Office of Partnerships in the Office of Regulatory Affairs (ORA) in the Office of Global Regulatory Operations and Policy (OGROP). As the Director, the incumbent serves as the Senior Partnerships Program Officer, who will be a key member of the senior management team of the Deputy Assistant Commissioner for Regulatory Affairs (ACRA) which has responsibilities for decision making processes and leads discussions and decision-making concerning ORA plans, programs, and activities, both during strategic planning sessions and in the actual determination, allocation, and administration of ORA program segment(s), functions, and activities.
The incumbent provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to ORA's regulatory goals and objectives. As the Senior Partnerships Program Officer, the incumbent serves as the principal advisor to the ACRA and is recognized as the person who can speak authoritatively for the ACRA on matters pertaining to the FDA/ORA partnerships programs.
The incumbent represents the agency in meetings, conference, and committees involving policy and other matters pertinent to the partnerships programs; coordinates program with State and local and other Federal agencies concerning the interpretation of regulatory requirements, impacts, and other issues.
The incumbent represents the ACRA with State and local regulatory and scientific entities, providing strategic recommendations and facilitating the development of stronger working relationships and new cooperative agreements and partnerships. Also represents the ACRA in dealing with and negotiating with representatives of Congress; HHS Operating Divisions, other Federal agencies; State, local, and, at times, foreign governments; the regulated industry; professional and industry organizations; and public interest groups;
Oversees the implementation of new laws and regulations which impact the mission of the Center. This includes responsibility for the initiation and implementation of new policies, systems, and procedures.
The incumbent is responsible for analysis of the impact of proposed changes to Agency laws and regulations, policies, and procedures which affect the functions, program segment(s), and activities of ORA's HQ and field offices that are involved with partnership efforts. Identifies changes and additions to the functions, program segment(s), and activities of ORA necessary to implement new legislation or regulations, and develops various scenarios for dealing with expansion or contraction of ORA functions, program segment(s), and activities in relation to partnership efforts.
The incumbent oversees, monitors and evaluates and provides guidance on the effectiveness of Regional and District Office partnership activities. Provides guidance on matters which cannot be resolved at the local level and coordinates efforts among the various offices.
Directs the staff of the Office of Partnerships and is responsible for the technical and administrative supervision through subordinate supervisors and/or team leaders of all Office employees which includes planning, assigning, reviewing, and evaluating the work and performance of those supervisors (or team leaders) and employees. The Office Director is recognized as the authority in the functions, and activities of the Office of Partnerships.