This position is located in the Office of Regulatory Affairs (ORA). The incumbent will serve as a Staff Specialist and personal advisor to the Director of the Office of Resource Management, ORA. He/she performs a wide range of difficult and confidential administrative duties. Directs the staff administrative functions of the office described in the FDA Staff Manual Guides.
The incumbent of this position is responsible for ensuring that the operations of the Office Director is accomplished effectively and efficiently. He/she relieves the Office Director of time consuming involvement in the management and coordination of special projects, particularly those projects which would otherwise necessitate their personal time and attention because of the highly complex technical, regulatory, or controversial nature of the issues involved. Plans and conducts management analysis on internal and external procedures, identifies and efficiently oversees timely completion of work assignments received in the Immediate Office of the Director. Coordination with other FDA offices, other PHS and HHS agencies, international organizations and regulatory professional organizations is assured through the incumbent's personal knowledge of the substantive nature of the work to be performed and the activities of the different organizations.
Actively interacts with the Office Director and his/her Deputy, and other senior FDA staff. Keeping abreast of ORA program activities and other agencies within the Federal government, international organizations and regulatory professional organizations. Through review of documents detailing the Office's significant activities, and other pertinent documents, keeps the Office Director and other key personnel apprised of Office activities, pending policy matters, and implications of current activities for the Office. this requires the incumbent to knowledge ably discern important issues, set priorities, and apprise appropriate member of the Office Director's staff of the circumstances which might alter or complicate issues requiring action by the Office Director. Action in this regard involves direct and tactful contact with the Office Staff.
Interpret and analyzes decisions to differentiate among priorities of the utmost importance the Office Director and his/her Deputy. understand the political awareness of issues as they relate to the on-going work of the Office.
Works closely with key officials within ORA and offices within the Center as well as serving as the liaison regarding clarification and dissemination of instructions and information.
Attends meetings that the Office Director has with each staff, as necessary, as well as meetings with outside organizations on a broad range of issues. Keeps abreast of the issues affecting Office activities. Collects and analyzes information pertaining to significant ORA activities and provides it to the Office director and other Key staff to assist in appropriate decision making.
Researches and/or provides the Office Director with a wide range of material and information such as pending legislation, budget, new programs, etc. to help him/her obtain a comprehensive view of problems and operations, and to understand the relationship and the long range impact of present decisions. Searches and /or reports specific information on ORA functions and activities that is required by the Director in making reports or are required by her/him for use in high level meetings.