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 descriptions below, select the one which best describes your specialized experience that meets the additional qualifications for the Supervisory Regulatory Counsel, GS-301-15. You must have at least 1 year of specialized experience equivalent to the next lower grade level (GS-14) 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.
Specialized experience is experience in supervisory role and familiarity with administrative policies, procedures, regulations; strategic initiatives and programs, principles and practices of the Agency necessary to serve as an expert in leading and improving Office wide program effectiveness and function.
2. Are you a current Federal competitive status employee working with the Food and Drug Administration serving on a career/conditional appointment?
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.
3. Evaluates the appropriateness of existing strategies, plans and program changes in Office, Center, and Agency.
4. Reviews and evaluates regulatory requirements for program adjustments to meet CDER, Agency and department needs and priorities.
5. Maintains current knowledge about drug legislation, regulations, guidance, internal policies, procedures, and trends.
6. Evaluates supervisors' performance and ensures consistency and equity in managing and rating across the office.
7. Provides oversight and technical expertise to address program operation needs.
8. Leads and assigns work to supervisors and managers.
9. Ensures completed and accurate work assignments and efficient work flow.
10. Negotiates and/or advocates with internal and external stakeholders to articulately represent compliance position, priorities, and initiatives.
11. Explains complex regulatory, scientific or technical information and considers the audience's level of understanding.
12. Communicates policies, procedures, and directives from higher level management to key staff.
13. Responds to correspondence from internal and external stakeholders.
14. Reviews proposals for regulations and policy statements and assures overall and regulatory consistency of written work products produced by the Office,
15. Drafts, reviews and edits a variety of documents, correspondences, and compliance actions.
16. Establishes guidelines methodologies and policies for the Office, CDER, and Agency in conjunction with the Office Director.
17. Reviews and approves strategic projects developed by the supervisors and managers for their program areas.
18. Knowledgeable of critical areas of drug compliance that are of interest to Congress and to upholding the mission of public health protection.
19. Review and approves standards of scientific and regulatory excellence and leads in strategic planning for the office.