This announcement has been amended to adjust the closing date.
This announcement has been amended to list major duties at the full performance level of this position and to be listed as a bargaining unit position.
This recruitment will include cut-off dates continuously every 30 business days. Please review the announcement and submit all required and supporting documents prior to the cut-off period you wish to be considered. Referrals for each additional cut-off will be issued at the need/discretion of the agency.
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.
As a Consumer Safety Officer in the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), you will utilize your technical background in biological science to effectively work with subject matter experts to develop language for consumers, explain complex issues, and maintain appropriate and professional raport with stakeholders.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CBER-MP-14-1109844 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
This job opportunity announcement will be used FDA-wide to fill additional vacancies within the same geographical locations.
The Consumer Safety Officer Specialty areas of need for the vacancies are as follows:
( Applicants will have the opportunity to respond within the questionnaire to background/experience involving the specialties listed.)
At the full performance level (GS-13) of this position the incumbent performs the following duties:
· Provides guidance and consultation regarding inspection and investigational methods and procedures necessary to accomplish compliance, enforcement, or regulatory objectives related to biologics.
· Presents guidance and instruction on licensing procedures.
· Acts as a primary or consultant reviewer on investigational new drug (INDs) submissions.
· Maintains regulatory oversight by the issuance of establishment and product licenses for manufacturers of blood and biologic components.
· Participates as subject matter specialist in onsite evaluations and inspections.
· Reviews and researches special and unusual problems related to biologics and biologic products.
· Serves as scientific and administrative contact for sponsors of new biological products.
· Occasionally represents the Agency at organized conferences and events.
· Communicates the status of Center Biologics Evaluation and Research policies and initiatives.