USA Jobs Announcement: https://www.usajobs.gov/GetJob/ViewDetails/379023200
Job Announcement Number: FDA-ORA-14-SL-1195986
The Office of Partnerships is announcing the vacancy position of Director of Office of Partnership. This position reports to the Deputy Associate Commissioner for Regulatory Affairs (DACRA), Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy (OGROP), within the Food and Drug Administration (FDA) in Rockville, Maryland.
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 Associate Commissioner for Regulatory Affairs (ACRA)/DACRA 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 segments(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 Director, OP, the incumbent serves as the principal advisor to the ACRA/DACRA and is recognized as the person who can speak authoritatively for the ACRA/DACRA on matters pertaining to the FDA/ORA partnership programs.
The incumbent represents the agency in meetings, conference, and committees involving policy and other matters pertinent to partnership programs; coordinates programs with State, local, and foreign governments and other Federal agencies concerning the interpretation of regulatory requirements, impacts, and other issues.
The incumbent represents the ACRA/DACRA with State, local and foreign 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/DACRA 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 ORA. 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, evaluates and provides guidance on the effectiveness of all ORA partnership activities. Provides guidance on matters which cannot be resolved at the local level and coordinates efforts amongst the various offices.
Directs the staff of OP 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 OP.