Read the statements below to determine what options (001 and 002) you are eligible to apply. You must enter at least one code.
001 - Merit Competitive: I am eligible to be considered under merit promotion procedures because I am a current FDA/Office of New Drugs (OND) Federal employee working in a permanent competitive service position (You must submit documentation to support your eligibility.)
002 - Noncompetitive: I am eligible to be considered under this specialty code because I am a current FDA/OND Federal service employees and currently hold or have held the same or higher grade level with the same promotion potential of this announcement will be referred to the hiring agency (You must submit documentation to support your eligibility.)
1. Are you a current career/career-conditional FDA-Office of New Drugs federal employee in the competitive service?A. Yes
2. Select the statement below that describes how you meet the Basic Requirements for this position.A. I have a degree that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
3. Select the statement that describes how you meet the Specialized Experience for this position at the GS-14 level.A. I have at least one full year of specialized experience (equivalent to the GS-14 grade level or higher in the Federal service) that included overseeing or leading a team of a scientific/regulatory health review process for multiple classes of drugs; providing authoritative technical guidance and consultative services to other agencies and representatives of a regulated industry on scientific and regulatory compliance matters related to drug development and the drug review process; and, developing policies and procedures for a regulated program.
For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.A- I have no experience in performing this work behavior.
4. Monitor a drug review process for multiple classes of drugs from initial submission to the time of approval, termination, or withdrawal.
5. Assure the timely resolution of scientific regulatory conflicts to avoid delays in achieving goals.
6. Lead staff in the tracking of regulatory requirements of FDA legislation as it pertains to product labeling, conducting post marketing studies, and authorizing civil penalties for non-compliance.
7. Advise staff in the compliance with Good Review Manufacturing Principles and Practices (GRMPPs), 21st Century Review, and Prescription Drug User Fee Act (PDUFA).
8. Oversee the development of project plans and performance goals to assure the completion of project goals.
9. Oversee communications with applicants on regulatory requirements, review findings and recommendations.
10. Coordinate staff in the tracking of applications managed while being reviewed by secondary and tertiary reviewers.
11. Establish short and long-term priorities to be completed related to the consumer safety officer/regulatory health project management discipline.
12. Direct studies and projects concerned with the analysis and evaluation of work related to the consumer safety officer/regulatory health project management discipline.
13. Assign work based on priorities, difficulty of assignments, and the capabilities of employees.
14. Provide advice, counsel, or instruction to employees on both regulatory work and administrative matters.
15. Recommend hiring, promotion, or reassignments.
16. Take disciplinary measures, such as warnings and reprimands.
17. Identify developmental and training needs of employees.
18. Work with senior level management or director to ensure policies and procedures are consistent with all applicable laws and regulations for a program.
19. Facilitate meetings to discuss and/or make decisions regarding program issues or discrepancies.
20. Represent a program office or organization in dealing and negotiating with organizational representatives such as: Congress; other Federal agencies; state, local, and foreign governments; regulated industries, professional and industry organizations, and public interest groups.
21. Participate in meetings, conferences, and symposia of scientific organizations to discuss issues affecting regulatory health project management.