1. Are you a current Food and Drug Administration (FDA) Federal employee working in a permanent appointment?A. Yes (you must submit an SF-50, Notification of Personnel Action)
2. Please choose the best response that indicates that you meet the basic requirements for a Biologist position.A. I possess a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position (must submit transcript at time of application submittal).
3. Please choose the best response that indicates that you meet the basic requirements for a Microbiologist position.A. I possess a degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent (must submit transcript showing coursework at time of application submittal).
4. Please choose the best response that indicates that you meet the basic requirements for a Chemist position.A. I possess a degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics (must submit transcript showing coursework at time of application submittal).
5. Do you have one year (52 weeks of full time employment) of specialized experience, equivalent to the GS-13 level in the Federal service, that included: serving as a scientific authority on regulatory and compliance concepts, methodologies, procedures, guidelines, and policies; reviewing and approving the development of regulations and guidance of a program office; leading and/or planning projects involving regulatory issues of pharmaceuticals, drug trials, or post marketing safety policies; preparing reports based on regulatory study results; and collaborating with external key officials or stakeholders on regulatory actions or issues?A. Yes (this specialized experience must be reflected in your resume)
For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.A- I have no experience in performing this work behavior.
6. Advise on compliance regulations and other legal issues within a drug safety program.
7. Ensure regulations and guidance are well-written and consistent with all applicable legal/regulatory requirements.
8. Advise personnel of new regulations, legislation, and trends in the industry from a legal/regulatory perspective.
9. Resolve program segment regulatory issues.
10. Serve as a scientific authority on regulatory and compliance concepts, methodologies, procedures, guidelines, and policies.
11. Assign project work to team members.
12. Evaluate projects or program elements designed to achieve critical or key scientific and regulatory goals.
13. Develop valid plans and approaches for projects designed to address compliance issues.
14. Plan complex projects elating to pharmaceutical policies, drug trials, or post marketing drug safety.
15. Represent a program in discussing controversial regulatory and scientific matters.
16. Serve as a scientific authority on regulatory and compliance concepts, methodologies, procedures, guidelines, and policies.
17. Present scientific information (e.g., data findings, observations, regulatory interpretations) at conferences and/or professional meetings.
18. Advise external stakeholders, consumers, and other counterparts on scientific, technical or regulatory issues impacting public health.
19. Prepare reports based on scientific findings relating to policies and procedures.
20. Draft proposals for new drug safety regulations and policy statements for a program.
21. Write procedures or guidance to improve program operations and processes.
22. Write correspondence in response to inquiries from agency officials, consumers, academia, and the regulated industry.