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. For the GS-15: applicant must have one year of specialized equivalent to the next lower grade level in the Federal Service. Examples of specialized experience at the next lower grade are as follow: developing guidance and providing advice regarding project management process and has primary responsibility for ensuring successful implementation and administration of project management initiatives. Researches, advises, initiates studies, and develops and coordinates policy concerning precedent setting review management issues.A. Yes, I have one year of specialized experience described above equivalent to the next lower grade level in the Federal Service.
2. Are you a current career/career conditional OND employee within Center for Drug Evaluation and Research (CDER)?A. Yes
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. Provides consultative service to other FDA Centers as well as other agencies within the government.
4. Exercises significant responsibilities in dealing with officials of other units or organizations and in advising mangement offiicials of higher rank.
5. Attends meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field, to exchange ideas with other scientific peers engaged in related areas and to acquire background information pertinent to the conduct of Division/Officer responsibilities.
6. Provides advice, counsel, or instruction to employees on both regulatory work and administrative matters.
7. Communications with industry on regulatory issues in order to resolve issues related to applications, facilitate technical information gathering for reviewers, and the explanation of regulatory requirements and serving communications on applications to ensures compliance with all legal, regulatory and policy requirements.
8. Interviews candidates for positions in the Division and recommends the appointment, promotion, or reassignment to such positions
9. Maintains an expert knowledge and keeps abreast of new findings by reading scientific literature as it relates to drug development and the drug review process; attends professional meetings to gain knowledge of current trends relative to work assignments.
10. Assures compliance with Good Review Manufacturing Principals and Practices (GRMPPs) 21st Century Review, and Prescription Drug User Fee Act (PDUFA) goals and deadlines are met.
11. Assures industry compliance with and tracking of all regulatory requirements of FDA legislation including FDAAA.
12. Assigns work to subordinates bases on priorities, selective consideration of the difficulty and requirements of the assignments and the capabilities of the employees.
13. Develops performance standards
14. Plans work to be performed by subordinate members, sets and adjusts both short-term and long-term priorities and prepares schedules for completion of work.