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 14.
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-14 grade level, applicants must have 52 weeks in a non-temporary appointment at the GS-13 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.
Examples are skills demonstrated through interfacing with multidisciplinary teams pertaining to New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) involving the application of the Food, Drug and Cosmetic Act and other applicable rules and regulations for human drugs; performing timely, high quality Chemistry, Manufacturing and Controls (CMC) review of new molecular entities, complex formulations and manufacturing processes; independently resolving technical issues of exceptional complexity and scope; applying the principles, theories, and practices of chemistry, technology, quality and other concerns associated with manufacturing processes and controls involved in research, development, and production of drugs for human use; drawing scientifically sound conclusions from a wide array of publications and studies in order to make cogent recommendations; completing reviews of quality-by-design (QbD) based submissions (individually or as a team member); contributing to CMC reviewer training activities on emerging regulatory or scientific issues.
A. Yes, I have the specialized experience for this position.
2. Are you a current Office of New Drug Quality Assessment employee.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. Conducts in-depth risk-based assessment of Chemistry, Manufacturing and Controls (CMC) information used to characterize and manufacture drug substances and drug products intended for human use as submitted in New Drug Applications (NDAs), Investigational New Drug Applications (INDs), amendments and supplements.
4. Reviews and evaluates scientific submissions to determine if the data submitted related to product quality, based on the knowledge of the chemistry, manufacturing and controls (CMC) of the product is adequate, and sufficient to support the quality of the drug under consideration and to meet the regulatory requirements.
5. Serves on a multi-disciplinary scientific/medical team that reviews, evaluates and decides on the approvability of scientific submissions and applications that request FDA regulatory approval for clinical research, human testing, and manufacture of human drugs.
6. Requests additional data or tests from sponsors or applicants and propose changes in manufacturing or controls when he/she determines they are needed to establish and maintain the identity, purity, strength and quality of the drug products.
7. Determines the need for and requests establishment inspections as part of the NDA approval process and to insure the safety of investigational drugs; and in addition brief inspectors prior to inspection of foreign facilities.
8. Reviews submissions to determine the technical content of labeling and ensures consistency with the information submitted in the application in compliance with labeling requirements of the law and regulations.
9. Evaluates the adequacy of methods, facilities, and controls used to characterize and manufacture drug substances and drug products.
10. Makes recommendations regarding the scientific and regulatory acceptability of the proposed drug synthesis, finished products formulation, specifications, and manufacturing processes and controls.
11. Participates in pre-approval inspections as necessary to serve in a scientific advisory role to better determine approvability and marketability of drug products.
12. Performs assessment of scientific submissions to ensure they are focused on critical quality attributes of the drug as they relate to product performances and its safety and effectiveness.
13. Evaluates the pharmaceutical development report in an NDA or supplement for information on product formulation and manufacturing process to determine if the applicant has a sound/supportable scientific understanding of the product and process and if the quality has been built in by design to mitigate risks to human use throughout the product's life cycle.
14. Prioritizes CMC issues according to their impact on the approvability of an NDA or supplement.
15. Prepares comprehensive summaries of findings and recommendations in scientific terms in writing.
16. Formulates and provides authoritative regulatory decisions and recommendations regarding approval based on the quality of the human drug.
17. Prepares correspondence in an informed and professional manner according to DHHS, FDA, and Center/Office standards.
18. Presents information in a concise and coherent manner.
19. Communicates effectively with a variety of employees and other individuals working at all levels of management in CDER.
20. Responds verbally to complex questions and participates in integrated discussions regarding technical information and comprehensive summaries of conclusions and regulatory recommendations.