Description of Duties:
- Inspect sites that perform nonclinical or clinical studies that have safety, efficacy, bioequivalence, bioavailability, or pharmacokinetic endpoints
- Provide advice and guidance regarding aspects of inspection findings, laboratory processes, or studies
- Review inspection reports of clinical and nonclinical sites and studies related to human and animal bioequivalence, bioavailability, or pharmacokinetics
- Evaluate animal safety and efficacy studies and in vitro bioequivalence studies to verify clinical trial data submitted to the FDA
- A four-year bachelor degree that included a major in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
- GS-12/13 at the headquarters and field levels