Job Overview

Summary

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

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: This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)Headquarter ONLY.  Current FDA/ORA HQ 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)

FDA/ORA HQ 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 (FDA), Office of Global Regulatory Operations and Policy (OGROP), Office of Regulatory Affairs (ORA), Office of Resource Management, Division of Human Resource Development in Rockville Maryland.

TYPE OF POSITION:  This position is being filled on a full-time, permanent basis.
PROMOTION POTENTIAL:  This is a career-ladder position; GS-13 is the full performance level. 
Additional selections may be made from this announcement.
Salary range listed above includes geographical locality pay.  

Duties

At the full performance level, the incumbent serves as a subject matter specialist in developing, coordinating, administering, monitoring, and evaluating a wide variety of national personnel certification programs, curricula, and or training courses to fulfill ORA's employee development mission.   Major duties include:  

·    Applying a broad understanding of investigation and regulatory case development processes toward the development of competency-indicating assessments.

·    Applying a broad understanding of regulatory policy toward personnel certification program development.

·    Participating in the development and administration of personnel certification programs by planning and coordinating the development and administration of a wide range of technical and semi-technical meetings; workshops; and related events to meet specific program needs and objectives; outlining specific workshop and or meeting objectives and selecting the appropriate venues to achieve the objective of the event.

·    Serving as a project officer and providing the project guidelines; consulting frequently with the contractor, makes periodic reviews of progress and project  details; reviewing completed products for technical adequacy, clarity, relevance and conformance with project objectives.

·    Facilitating workgroups; administering training; and proctor examinations as needed.

·    Conducting site visits and audits of contractor facilities to assess suitability for project deliverable such as evaluating adequacy of test administration locations.

·    Collaborating with FDA and related stakeholders to develop and deliver certification programs.

·    Using qualitative and quantitative methods to evaluate program effectiveness.

·    Participating in the development, coordination, and facilitation of workshops for program staff.

·    Participating in program related evaluations to demonstrate ability to achieve goals.

·    Developing and administering databases related to test administration and delivery of certification program. ·    Actively participating in other professional development related duties. 

Duties at the trainee level will be selected by the supervisor and will be developmental in nature.