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AMENDMENT: The closing date has been extended to 6/26/2014.
This announcement is open continuous till the closing date with the following cut-off dates for certification:
As a Pharmacologist in the Immediate Office of the Director, Office of Generic Drugs, you will provide scientific expertise in the area of biopharmaceutics and pharmacokinetics; consult with the Director for Science on the use of computers in statistical pharmacokinetics analyses; apply in-depth knowledge of chemistry, pharmacokinetics, physiology, pharmacology, pharmacy, and medical science in resolving complex review issues; and develop generic drug standards.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-14-1027419 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 may be used FDA-wide to fill additional vacancies within the same geographical location.
- Reviews a wide range of drug applications received from the pharmaceutical industry to determine the adequacy of bioequivalence sections.
- Evaluates innovations in physico-chemical in vitro technology for monitoring drug quality, developing new human drug evaluation protocols, and evaluating data by sophisticated, statistical and pharmacokinetic computer analyses.
- Conducts and manages research to develop new bioavailability and bioequivalence standards and improve existing standards.
- Consults on the evaluation of drug bioavailability and pharmacokinetic data.
- Prepares responses to petitions and other correspondence inquiries on matters related to the bioequivalence of generic drugs.
- Plans, directs, implements, and evaluates complex issues in a regulatory research.