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THE CLOSING DATE OF THIS ANNOUNCEMENT HAS BEEN EXTENDED TO 10-28-13.
The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing 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: Current career or career-conditional employees of the Dept. of Health and Human Services (DHHS); displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP); or DHHS employees currently serving under a SCH-A appointment. 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.
DHHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
The salary listed in the vacancy announcement includes the geographical locality pay.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations, Division of Medical Products & Tobacco Program Operations, Medical Products and Tobacco Trip Planning Branch located in Rockville, Maryland.
TYPE OF POSITION: This position is being filled on a full-time, permanent basis.
PROMOTION POTENTIAL: This is not a career-ladder position; GS-13 is the full performance level.
Additional selections may be made within the same geographical area within FDA-wide.
The incumbent serves as the international investigation and inspection expert in drugs and is responsible for assisting in the planning, establishing, directing, and implementing of the International Inspection Programs. Major duties include:
- Appraise and evaluate the overall effectiveness of the international inspection programs and developing new concepts as needed.
- Maintains continuing coordination with appropriate FDA units such as the Office of the Commissioner, Senior Associate Commissioner for Regulatory Affairs, Senior Associate Commissioner for International Activities and Strategic Initiatives, the Centers for Drug Evaluation and Research, Biologics Evaluation and Research, Food Safety and Applied Nutrition, Devices and Radiological Health, and Veterinary Medicine.
- Prepares the annual international travel plan for ORA, field and headquarters elements and the International Operations Branch fiscal operating plan.
- Selects appropriately qualified investigators to conduct inspections and provide technical support. Arranges briefings, orientations, training, and familiarization for the selected investigators and debriefing sessions when necessary following foreign inspection trips. Arranges for the submission of a summary report within the specified period after trip completion as set forth in Chapter 20-40, Foreign Travel reports, of the General Administration Manual.
- Serves as the trip coordinator for the operating investigators while they are actually participating in the program conducting international inspections.
- From time-to-time participates in inspections, writing the inspectional report and endorsement and appropriately forwarding the inspectional report. Attends meetings in foreign countries with foreign government officials, maintaining relations with foreign firms and advising the office of the Commissioner on the foreign inspection program and related activities.
- Coordinates with CFSAN, CDRH, CBER, CDER and CVM for the preparation of detailed work plans taking into account current inspectional problems, timing or seasonal factors, and logistics.
- Reviews the accomplishment of the international assignments and recommending proposed action to the Director, International Operations Branch, and ultimately to the Center involved, as to violative conditions found on all including the most complex and significant ones that involve precedent establishing considerations of nationwide importance.
- Provides a focal point within FDA to whom the headquarters and field service may turn for authoritative guidance and consultation regarding inspection and investigation methods and procedures necessary to accomplish compliance objectives.
- Selects appropriate methods for inclusion in nationwide manual issuance systems. Ensures that descriptive material communicates in sufficient detail to satisfy the needs of the operating investigators. Receives an resolves inquiries in this regard and, as necessary, makes onsite field visits to clarify problems and demonstrate approved techniques.
- Conducts research to develop improved inspectional techniques requisites for coping with advances in manufacturing technology and bulk distribution practices. In making these studies, explores backgrounds, conditions, and goals with program officials and subject matter specialist in the Centers and in the field.
- Collaborates with, and provides expert subject matter guidance to the Professional Development Officer in the design and formulation of nationwide training programs for investigators. As assigned, may serve as course instructor, direct, or monitor.
- Reviews and determines the usefulness of employee suggestions emanating from FDA field employees. Endorses with recommendations for acceptance in whole or in part, or furnishes reasons outlining basis for rejection.
- As assigned, participates as a subject matter specialist in the onsite evaluation of field activities. Identifies areas which warrant further study and attention by the field to ensure optimum operating efficiency and resource utilization.
- Carries out other duties of a comparable level of responsibility and complexity as operational needs and workload dictate.