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 under a Special Appointing Authority (e.g. Veteran's Recruitment Appointment, present or former Peace Corps personnel, current Postal Service personnel, etc?
Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.
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 experience and/or education which meets the Minimum Qualification Requirements for Regulatory Health Project Manager-0601-13.A. Yes, I do have one year of specialized experience at the next lower grade level.
2. Are you a current Federal employee within Food and Drug Administration?A. Yes
3. Manages the drug review process for one or more classes of drugs from initial submission to the time of approval, termination or withdrawal.
4. Acts as a driving force for the timely completion of project activities and attainment of project objectives.
5. Assures timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving goals.
6. Communicates directly with industry counterparts to resolve issues, facilitate technical information gathering for reviewers, and explain all current regulatory requirements.
7. Initiates correspondence regarding action, policy issues or request for additional information.
8. Responds to requests for additional information and recommends solutions to problem areas.
9. Identifies project activities or situations that may adversely impact project plan and advising supervisor, team members and management of potential impact and, with the team, recommending solutions to problem areas.
10. Interfaces and interacts on a daily basic with other regulatory project managers and scientific reviewers in other FDA components.
11. Serves as the contact point for communications concerning applications in the assigned classes and handles subject matters with broad, controversial and sensitive nature, and complex implications for FDA programs and the public health.
12. Manages and coordinates the work of the review team members for the specific drug application
Review to determine how much progress is being made and if any problems are surfacing.
13. Develops project plans, including setting time frames, milestones, and agrees upon endpoint.
14. Serves as a co-leader of the review team, responsible for the management of activities of the review team including scheduling meetings, and preparing issued-based agendas and official records of the meetings.