Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name. As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.
Are you an ICTAP Eligible?
For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap. To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.
Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?
Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.
Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)
Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?
Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers. This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.
Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 15.
If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?
Select/enter at least one occupational specialty. The specialty code for this position is:
Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:
1. From the description below, select the one which best describes your
education and meets the Basic Qualification Requirements for Pharmacologist,
2. From the description below, select the one which best describes your education and meets the Basic Qualification Requirements for Toxicologist, GS-415:A. Degree: 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. Evaluation of Education: The positions in this series are multidisciplinary positions because the work may involve the application of a scientific knowledge of anatomy, chemistry, biochemistry, physiology, pathology, toxicology, and related sciences musch as microbiology, biophysics, entomology, genetics, mathematics, and statistics.
3. To qualify for the GS-15, in addition to the basic education requirement, you must have one year specialized experience equivalent to the next lower grade level in the Federal service. Specialized experience is experience that has equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled and can be demonstrated through skill with a regulatory area of expertise and knowledge of one or more professional fields (e.g Pharmacology, chemistry, biology, microbiology or pharmacy) and skill sufficient to identify and understand the most difficult, complex, and broad Agency regulatory issues; experience interpreting, evaluating and explaining pharmacological/toxicological data/regulations and polices. Interdisciplinary positions are classified to be specific series which have been determined to be appropriate for the vacancy based on the duties and responsibilities of the positions and general qualifications to perform the work.A. Yes, I have one year of specialized experience described above equivalent to the next lowergrade level, in the Federal service.
4. Are you a current career or career conditional employee within Office of New Drugs (OND)A. Yes, I am current Office of New Drugs (OND)
For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.A- I have not had education, training or experience in performing this task.
5. Review and evaluate scientific submissions focusing on the toxicological otential of drugs in support of proposed clinical studies or proposed dosage regimes in the labeling.
6. Review and evaluate the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of drug applications, supplements and other related scientific submissions to assess the safety of the drug.
7. Serve as a CDER/Agency resource for information on current concepts in pharmacology and toxicology, participating in professional committees and working groups both within and outside of CDER and FDA.
8. Plans work to be performed by subordinate members, sets and adjust both short term and long-term priorities, and prepare schedules for completion of work.
9. Assigns work to subordinates bases on priorities, selective consideration of the difficulty and requirements of the assignments, and the capabilities of employees
10. Develops performance standards
11. Interact with industry representative on the exchange of information and the provision of guidance regarding aspects of the application, notice, amendment, supplement or report.
12. Prepares comprehensive summaries and integrated discussions of data submitted for review.
13. Provide comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.
14. Hear and resolve complaints from employees referring more serious unresolved complaints to a higher-level manager or supervisor.
15. Interview candidates for positions in the Division and recommend the appointment, promotion or reassignment to such positions.
16. Provide comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.