1. Please select the response below that indicates how you meet the basic requirement for a Chemist position.A. I have completed a four year course of study leading to a Bachelor's or higher degree in the 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 transcripts)
2. From the descriptions below, please choose the BEST answer that demonstrates your experience related to this position.A. I have at least one year of specialized experience equivalent to the GS-12 grade level or higher in the Federal service utilizing knowledge of theories, principles, and methods in the field of chemistry; evaluating and incorporating guidelines and regulations in the area of human drugs; applying knowledge of laws and regulations pertaining to drugs and their impact on industrial environment; and providing advice to stakeholders on abbreviated new drug applications (ANDA's).
In this part, you will respond to questions about experiences you have had that are related to the requirements of the job for which you are applying. Carefully review the response descriptions listed below. For each question or statement, select the one response description that best describes your experience, education, or training.A- I have no experience in performing this work behavior.
3. Review and evaluate abbreviated new drug applications, amendments, and reports.
4. Review and evaluate sponsor data and results.
5. Review pharmaceutical developmental manufacturing using modern approaches.
6. Determine whether a submission is adequate to meet the requirements of laws, regulations, and guidelines.
7. Advise others in the application of regulations and guidance.
8. Apply knowledge of laws and regulations to the review of applications.
9. Interpret the rules to industry representatives.
10. Identify problems with no direct application rule or guideline.
11. Research indirect related information to assist in determining a course of action.
12. Resolve technical issues.
13. Communicate deficiencies to representatives of the regulated industry.
14. Contribute to guideline development.
15. Provide advice to other reviewers.
16. Prepare written evaluations showing the results of scientific review.
17. Compose papers and reports to provide advice and information to scientist.
18. Write responses to request for guidance and information.