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*****THIS ANNOUNCEMENT HAS BEEN EXTENDED DUE TO SYSTEM UNAVAILABILITY****
The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
Who May Apply: This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) ONLY. Current FDA employees serving under a Schedule-A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered.
YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action) OR YOUR APPLICATION WILL BE CONSIDERED INCOMPLETE.
Current FDA Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to the selecting official as Commissioned Corps (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Policy and Risk Management located in Silver Spring, Maryland.
The salary listed in the vacancy announcement includes the geographical locality pay.
TYPE OF POSITION: This position is being filled on a full-time, permanent basis.
PROMOTION POTENTIAL: This is not a career-ladder position; GS-14 is the full performance level.
Additional selections may be made within the same geographical area within FDA.
Incumbent serves as the Special Assistant to the Office Director, ORA/Office of Policy and Risk Management. The Special Assistant applies knowledge of management and program analysis to define critical questions and oversees the development and application of analytical approaches to answer those questions; and directs the design and conduct of comprehensive quantitative and qualitative studies, to critique, design, install, and improve program management, organizational development, strategic planning, and decision models. Major duties include:
- Serves as the senior analyst responsible for independently planning, analyzing, and evaluating the effectiveness of Office program and /or administrative operations, performing a variety of highly complex analytical study assignments requiring a mastery of the application of qualitative and quantitative methods for the assessment and improvement of program(s) operations, implementation and/or effectiveness.
- Performs unusually difficult and comprehensive analyses that require occupational expertise, judgment and a high degree of qualitative and quantitative analytical skills to support particularly complex program activities on a continuing and frequent basis and require developing detailed plans, goals, and objectives for the long-range implementation, administration and change of the program, as well as developing criteria for evaluating the effectiveness of the program.
- Analyzes and evaluates aspects of substantiative, mission-oriented programs.
- Develops novel ways to resolve problems in meeting established goals, measures, and objectives for program effectiveness.
- Develop, recommend and implement operational policies and procedures designed to insure consistency and balance throughout the Office.
- Performs special assignments on behalf of the Office Director.
- Identifies and assesses emerging, standing, complex, or precedent-setting issues impacting on ORA operational procedures, policies, activities, and resources.
- Advises the Office Director of potential and emerging policy issues and the need to formulate appropriate program responses in support of new initiatives.
- Develops and reviews proposals for higher official review that may include highly complex legislative and regulatory proposals relating to assigned program areas.
- Conducts policy and program analyses of assigned programs. Reviews program management activities, regulation development, and other programmatic initiatives.
- Prepares policy options and represents the Office at meetings with external entities regarding program policy issues.