- Position Title
- Regulatory Health Project Manager
- Agency
- Food and Drug Administration
- Announcement Number
- FDA-CBER-19-DE-10354099 Opens in new window
- Open Period
- Wednesday, October 3, 2018 to Wednesday, October 17, 2018
For preview purposes only. To apply, please return to the USAJOBS announcement and click the Apply button.
Eligibilities
PLEASE READ THE FOLLOWING ELIGIBILITY QUESTIONS VERY CAREFULLY. YOUR RESPONSES WILL AFFECT YOUR CONSIDERATION FOR THIS POSITION!
This advertisement is listed in accordance with Merit Promotion procedures. This means that only specific groups of applicants are eligible for consideration. The following questions will determine if you are within any of these specific groups eligible for consideration under this advertisement. You will only be considered for each eligibility which you respond "yes" to. If you respond "no" to all eligibility options in this list, your application will not be considered under this advertisement.
For more information about eligibility, please review the following article on USAJOBS, "Which jobs am I eligible to apply for?" located at: https://www.usajobs.gov/Help/faq/application/eligibility/
If you still have questions about this advertisement or your potential eligibility, please e-mail quickquestions@fda.gov or call 888-478-4340.
This advertisement is listed in accordance with Merit Promotion procedures. This means that only specific groups of applicants are eligible for consideration. The following questions will determine if you are within any of these specific groups eligible for consideration under this advertisement. You will only be considered for each eligibility which you respond "yes" to. If you respond "no" to all eligibility options in this list, your application will not be considered under this advertisement.
For more information about eligibility, please review the following article on USAJOBS, "Which jobs am I eligible to apply for?" located at: https://www.usajobs.gov/Help/faq/application/eligibility/
If you still have questions about this advertisement or your potential eligibility, please e-mail quickquestions@fda.gov or call 888-478-4340.
1.
Do you claim Veterans' Preference?
2.
Do you wish to be considered under a CTAP (Career Transition Assistance Plan) eligibility?
You may qualify for CTAP eligibility if all of the statements apply to you:
To verify your eligibility for CTAP:
You must submit supporting documentation such as a Reduction in Force (RIF) separation notice or a Proposed Removal/Separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action showing position, tenure code, grade & step, and full name/DOB/SSN.
You may qualify for CTAP eligibility if all of the statements apply to you:
- You are located in the same local commuting area of the vacancy.
- You have been (or will be) involuntarily separated from the agency advertising this position, due to a reduction-in-force.
- You are applying to a position that is at (or below) the grade level of the position separated from.
- You are applying to a position that does not have greater promotion potential than the position separated from.
- Your last performance rating of record is at least "fully successful" or equivalent.
To verify your eligibility for CTAP:
You must submit supporting documentation such as a Reduction in Force (RIF) separation notice or a Proposed Removal/Separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action showing position, tenure code, grade & step, and full name/DOB/SSN.
3.
Do you wish to be considered under the Schedule A eligibility for people with disabilities?
You may qualify for this eligibility if you have a severe physical, psychiatric, or intellectual disability, that limits one (or more) of your life functions, and qualifies based on Schedule A provisions. You can read more about Schedule A on the USAJOBS website. Learn more about this eligibility on the Individuals with Disabilities page on USAJOBS...
To verify your eligibility:
You must provide appropriate medical documentation, such as a letter signed by a licensed medical professional or licensed vocational rehabilitation specialist stating your condition, fitness to work, and any related work restrictions. This documentation must be provided with your application. You will not be able to provide this documentation once the vacancy announcement closes.
You may qualify for this eligibility if you have a severe physical, psychiatric, or intellectual disability, that limits one (or more) of your life functions, and qualifies based on Schedule A provisions. You can read more about Schedule A on the USAJOBS website. Learn more about this eligibility on the Individuals with Disabilities page on USAJOBS...
To verify your eligibility:
You must provide appropriate medical documentation, such as a letter signed by a licensed medical professional or licensed vocational rehabilitation specialist stating your condition, fitness to work, and any related work restrictions. This documentation must be provided with your application. You will not be able to provide this documentation once the vacancy announcement closes.
4.
Do you wish to be considered under the ICTAP (Interagency Career Transition Assistance Plan) eligibility?
You may qualify for ICTAP if all of the following statements apply to you:
To verify your eligibility for ICTAP:
You must submit a Reduction in Force (RIF) separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action, showing the agency, position held, tenure and appointment codes, and full biographical information (name, DOB, and SSN).
You may qualify for ICTAP if all of the following statements apply to you:
- You are located in the same local commuting area of the position being advertised.
- You were (or will be) separated from a position at an agency outside of the FDA due to a reduction-in-force.
- You are applying to a position that is at (or below) the grade level of the position from which you have been (or will be) separated.
- You are applying to a position that does not have greater promotion potential than the position from which you have been (or will be) separated.
- Your last performance rating of record is at least "fully successful" or equivalent.
To verify your eligibility for ICTAP:
You must submit a Reduction in Force (RIF) separation notice to include your latest performance rating (if the notice does not have this information included, you must also submit a copy of your most recent performance appraisal) and a copy of your latest SF-50: Notification of Personnel Action, showing the agency, position held, tenure and appointment codes, and full biographical information (name, DOB, and SSN).
5.
VETERANS PREFERENCE INFORMATION
The vacancy you are applying to is being advertised under Delegated Examining (Category Rating) procedures, in accordance with Title 5 of the US Code. Veterans and certain military spouses are able to receive a preference eligibility based on prior military service, disability, or survivorship. You can read more about each eligibility option by clicking the links below. If you answer "yes" to this question, you are indicating that you have read and understand the supporting documentation requirements, and that you will provide these supporting documents in your application. Missing or inaccurate supporting documents may result in your preference claim being adjudicated as ineligible. It's very important that you make the correct selection and provide the required information and documentation for us to verify any claim you submit.
There are three types of Veterans Preference:
See the FedsHireVets Job Seekers page for more information on how preference is applied, how to claim a preference, and what documentation you may need to supply.
You can also check out the USAJOBS Veterans site as well.
Having reviewed this information, do you intend to claim any kind of spousal or veterans preference in your application to this announcement?
The vacancy you are applying to is being advertised under Delegated Examining (Category Rating) procedures, in accordance with Title 5 of the US Code. Veterans and certain military spouses are able to receive a preference eligibility based on prior military service, disability, or survivorship. You can read more about each eligibility option by clicking the links below. If you answer "yes" to this question, you are indicating that you have read and understand the supporting documentation requirements, and that you will provide these supporting documents in your application. Missing or inaccurate supporting documents may result in your preference claim being adjudicated as ineligible. It's very important that you make the correct selection and provide the required information and documentation for us to verify any claim you submit.
There are three types of Veterans Preference:
- Disabled (10-point preference eligible)
- Non-Disabled (5-point preference eligible)
- Sole Survivorship (0-point preference eligible)
See the FedsHireVets Job Seekers page for more information on how preference is applied, how to claim a preference, and what documentation you may need to supply.
You can also check out the USAJOBS Veterans site as well.
Having reviewed this information, do you intend to claim any kind of spousal or veterans preference in your application to this announcement?
6.
In the last five years, based on the closing date of this announcement, have you served or are you currently serving as an Executive Branch political, Schedule C, or Non-career SES appointee?
You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed.
You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed.
- A political appointee is an appointment made by the President without confirmation by the Senate (5 CFR 213.3102(c)) OR an assistant position to a top-level federal official if filled by a person designated by the President as a White House Fellow (5 CFR 213.3102(z)).
- A Schedule C appointee occupies a position excepted from the competitive service by the President, or by the Director of OPM, because of the confidential or policy-determining nature of the position duties (5 CFR 213.3301 and 5 CFR 213.3302).
- A Non-career SES appointee is approved by the White House and serves at the pleasure of the appointing official without time limitations (5 CFR 317 Subpart F).
Preferences
1.
Select the lowest grade you are willing to accept for this position.
Assessment 1
Thank you for your interest in a position with the Food and Drug Administration. Your resume and the responses you provide to this assessment questionnaire will be used to determine if you are among the best qualified for this position. Your responses are subject to verification. Please review your responses for accuracy before you submit your application.
1.
From the description below, select the one which best describes your education and meets the Basic Qualification Requirements for Regulatory Health Project Manager, GS-0601.
2.
Select the one statement that best describes the specialized experience that you possess that demonstrates your ability to perform the work of a Regulatory Health Project Manager at the GS-11 grade level or equivalent pay band in the Federal Service.
3.
Select the one statement that best describes the specialized experience that you possess that demonstrates your ability to perform the work of a Regulatory Health Project Manager at the GS-12 grade level or equivalent pay band in the Federal Service.
Select the one statement that most accurately describes your training and experience carrying out each task using the scale provided.
4.
Serve as co-leader of the review team with the scientific co-leader.
5.
Responsible for the management activities of the review team, including scheduling meetings, and preparing issued-based agendas and official records of the meetings.
6.
Negotiate the timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving goals.
7.
Act as a driving force for the timely completion of activities and attainment of objectives within established project plans and performance goals set by team.
8.
Review team (scientific, regulatory, and management) to develop project plans, including setting time frames, milestones, and an agreed upon endpoint.
9.
Monitor and report actual status of all activities within the assigned projects.
10.
Identify project activities or situations that may adversely impact project plan and advising supervisors, team members and management of potential impact.
11.
Recommend solutions to problem areas.
12.
Manage the review process for one or more classes of biological products from initial submission to the time of approval, termination or withdrawal.
13.
Provide authoritative advice and counsel to all parties engaged or interested in the review process.
14.
Review applications to ensure compliance with all legal, regulatory and policy requirements.
15.
Apply quality control systems and quality assurance methods to determine risks and compliance standards for work.
16.
Implement associated risk mitigation actions.
17.
Ensure work meets quality requirements and agency contracts, as modified