Vacancy ID: 778433 Announcement Number: HHS-FDA-CDER-MP-13-778433 USAJOBS Control Number: 331037500Occupational/Assessment Questions:
AREA OF CONSIDERATION - FDA CDER OND-Wide
1. From the descriptions below, select the letter that best describes your eligibility for this position. You MUST select one response or you will be rated ineligible.A. I currently work for the Office of New Drugs (OND) in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), with a career or career-conditional appointment in the competitive service or in the Public Health Service.
B. I do not currently work for the Office of New Drugs (OND) in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), with a career or career-conditional appointment in the competitive service or in the Public Health Service.
BASIC QUALIFICATION REQUIREMENT
2. Please select the response below that best indicates how you meet the basic education requirement for a Toxicologist position. Remember, if your answer is 'A' below, you MUST provide a copy of your college transcript (official or unofficial) or a list of college courses showing the name of the institution attended, grade received and semester/quarter hours completed to document how you meet this requirement. Failure to submit appropriate education verification will result in an ineligible rating.A. I possess a Bachelor's or higher degree in toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology. (Courses in anatomy, chemistry, organic chemistry, biochemistry, biology, histology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry, biochemistry, and physiology. Courses in statistics, bioassay, and test design may also apply to this requirement. Courses in cytology, embryology, cellular or microbial genetics, and biophysics may also be used to meet this requirement in those instances where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved. Only toxicology courses may be used to meet the requirement for 12 semester hours in toxicology. This may include courses dealing intensively with toxicological search, methods in toxicology, and essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects.). I certify that I have submitted supporting documentation to verify my education.
B. I do not have education as listed above; therefore I do not qualify for this position.
3. Select one response that demonstrates how you meet the Additional Qualification requirement for the GS-14 grade level of this position.A. I have at least one year of specialized experience equivalent to the GS-13 grade level in the federal Government (can be obtained in the public or private sector). This experience includes: reviewing scientific submissions focusing on non-clinical in vitro and animal data and evaluation of toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in the labeling; reviewing the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologic Licensing Applications (BLAs) amendments, supplements and other related scientific submission to assess the safety of the drug; preparing comprehensive summaries and integrated discussions of data submitted for review. I certify that my resume fully demonstrates my knowledge, skills and abilities to perform the work of this position.
B. I do not meet the additional qualification requirement defined in response A and do not qualify for this position.
PHARMACOLOGY PRINCIPLES AND METHODS
For the following questions, choose ONE statement from the list (A through E) below that best describes your HIGHEST level of work experience in the task. Your answers to these task statements must be supported by your resume or your score may be lowered.A- I do not have experience in performing this task.
B- I have had education or training in performing this task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or I am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.
4. Review and evaluate scientific submissions focusing on non-clinical in vitro and animal data.
5. Evaluate pharmacological potential on all organ systems, tissues, and cells, and on the animal in general.
6. Review and evaluate the results of non-clinical pharmacological studies submitted by the drug sponsor/applicant.
7. Serve as a resource for information on current concepts in pharmacology.
8. Maintain expert knowledge and keep abreast of new findings by reading toxicological, pharmacological, biochemical and immunological scientific literature, participating in professional meetings.
TECHNICAL COMPETENCE IN AGENCY RULES, REGULATIONS, AND PROCEDURES
9. Apply new developments and theories to critical and novel problems.
10. Extend and modify approaches, precedents and methods to solve a variety of toxicology problems with unprecedented and obscure aspects.
11. Serve as a resource for information on current concepts in toxicology and pharmacology.
12. Submit substantive regulatory recommendations and conclusions for concurrence by the scientific supervisor.
13. Meet with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review.
14. Attend meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field.
15. Understand new guidance in order to keep abreast of current trends relative to work assignments.
16. Participate in professional committees and working groups.
17. Prepare comprehensive summaries and integrated discussions of data submitted for review.
18. Provide consultative service to other centers as well as other agencies within the Government.
19. Provide guidance and/or regulatory expertise to address and solve complex regulatory issues consistent with technological developments or new scientific evidence.
SECTION II. CERTIFICATION OF INFORMATION ACCURACY
20. Your responses in this Assessment Questionnaire are subject to evaluation and verification. Later steps in the selection process are specifically designed to verify your responses. Deliberate attempts to falsify information may be grounds for disqualifying you or for dismissing you from employment following acceptance. Please take this opportunity to review your responses to ensure their accuracy. By agreeing to the statement below, you are confirming that you have reviewed your responses to this questionnaire for accuracy, and verify that your responses accurately describe your current level of experience and capability.A. Yes, I verify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I accept that if my supporting documentation and/or later steps in the selection process do not support one or more of my responses to the questionnaire that my rating may be lowered and/or I may be removed from further consideration.
Failure to agree to the statement below will disqualify you from further consideration for this position.
B. No, I do not accept this agreement and/or I no longer wish to be considered for this position.