Duties

Summary

This position is in the Food and Drug Administration, Center for Drug Evaluation and Research, Office of the Center Director, Drug Safety Operations located in Silver Spring, MD. As Project Specialist, handles center-wide projects encompassing all offices and Divisions in the Center; and works with staff on varied projects within the Office. This position reports to the Associate Director for Drug Safety Operations.
Learn more about this agency

Responsibilities

• Recommends solutions and assures timely resolution of administrative conflicts or problems to avoid delays in achieving goals with supervisory approval.
• Handles center-wide projects encompassing all offices and Divisions in the Center; and works with staff on varied projects within the Office.
• Serves as primary point of contact for staff within the Office to provide the up-to-date status of all projects; gathers data to complete projects, and researches relevant records and consolidates information.
• Responsible for the management and evaluation of correspondence system to assure necessary and timely identification and processing of inquiries and other correspondence and documents for referral.

Travel Required

25% or less - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
11

Requirements

Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
• A probationary period may be required.

Qualifications

The position of Project Specialist falls under the 0301 occupational series. To qualify for this position at grade GS-7/9, you must meet Time-in-Grade requirements by 11:59 pm EST on 06/21/2021.

Applicants must meet the minimum qualification requirements.

Minimum Qualification Requirements:
GS 07- In order to qualify for the GS-07, applicants must have one year of specialized experience, equivalent to the GS-05 in the Federal service to include: 1) Assists in responding to inquiries addressing program management issues, such as on time and attendance, and frequently requested program-specific technical information; 2) Assists in preparing a variety of documents for department such as (sop's, department policies, decision papers, etc.); 3) Participates in special projects related to the responsibilities of the office. -OR-
One (1) full year of graduate level education or superior academic achievement.

GS 09- In order to qualify for the GS-09, applicants must have one year of specialized experience, equivalent to the GS-07 in the Federal service to include: 1) Responds to inquiries addressing program management issues, such as on time and attendance, and frequently requested program-specific technical information; 2) Prepares a variety of documents for department such as (SOP's, department policies, decision papers, etc.); 3) Provides advice for the automation of work processes such as automated documents, records, budget, and reports. -OR-
Master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related.

Specialized Experience. Specialized experience is experience that 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.

Note: One year of full-time graduate education is considered to be the number of credit hours that the school you attended has determined to represent one year of study. If this information cannot be obtained from your school, we will consider 18 semester/27 quarter hours to be equal to one year of full-time study. This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic Qualification requirement section. If the transcript(s) does not clearly demonstrate this, you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this.
Preferred Experience: Highly qualified applicants will be familiar/have experience with 1) platforms such as Microsoft Teams, Zoom to support collaboration, calls, meetings and 2) document management/intranet platforms to store, collaborate, and share information across the organization (e.g. SharePoint Online).

Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement.

In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply!

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login , select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran , individual with a qualifying disability , or a displaced employee , you will be required to provide other supporting documents as applicable. See the Required Documents section for details.
Be sure that any files you upload as supporting documentation are free of security or compression features which render such documents unreadable to our system.

Education

EDUCATION:
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education .

TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Electronic Transcript Caution : If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.

FOREIGN EDUCATION
Applicants
using part or all of their education completed outside of the U.S. to meet the qualification requirements
, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.
Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

National Association of Credential Evaluation Services (NACES)

Association of International Credentials Evaluators
(AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation

Additional information

For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest, FDA reserves the option of setting an application number limit.
When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either:
(A) the day the limit is reached, -OR-
(B) the pre-defined closing date of , whichever comes first.
If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET.
The application limit for this advertisement, if applicable, is: 100

For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/

ADDITIONAL CONDITIONS OF EMPLOYMENT THAT MAY BE REQUIRED

Pre-employment physical: NO

• Drug testing: NO
• License: NO
• Mobility agreement: NO
• Immunization: NO
• Bargaining Unit Position: YES, 3591
• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
If you are serving, or have served in the last 5 years (from ) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. 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. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM Special Appointing Authorities: If you are applying to this announcement based a special eligibility, such as those for people with disabilities, veterans (or military spouses), or displaced employees under a career transition program, please pay careful attention to the Required Documents section for details on application requirements for each eligibility path, to include supporting document requirements.

All requirements must be met by the closing date of this announcement (06/21/2021 ); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics .

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm EST on06/21/2021 ), a r eview of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities. Additionally, we will review your supporting documents and resume to determine if you are in the "Area of Consideration" for this vacancy. Government-Wide Merit Promotion vacancies may only accept applications from a limited audience, pay careful attention to the "Who May Apply" and the "Hiring Paths" information. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories: Best Qualified, Well-Qualified or Qualified.
Interagency / Career Transition Assistance Program (I/CTAP):Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site .
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies.

Administration and Management

Project Management

Writing

Oral Communication

To preview the application questionnaire, click the link below
https://apply.usastaffing.gov/ViewQuestionnaire/11128181

Background checks and security clearance

Security clearance
Not Required

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Suitability/Fitness

Required Documents

REQUIRED DOCUMENTS:

• Resume

Resume Requirements:

• Resume Writing Tutorial
• Resume Writing FAQ

ACCEPTED DOCUMENTS:

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (Schedule A)
• Disability Letter (VA)
• License
• Other supporting documentation not listed above
• PCS Orders
• Performance Appraisal
• Professional Certification
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

*Accepted documents may be required for some applicants depending on which eligibility options you're applying for, see the list below for details for each eligibility. If you need help submitting documentation, please see Applicant Help Site - Documents . If you are still unsure what documents might be required of you, please contact the FDA Applicant Help Desk before the announcement closes. For transcript submission requirements, see the Education section.

Current and Former Federal Employees:
To properly verify eligibility and time-in-grade, you must submit the following:

SF-50 from your most recent Promotion, Within Rate/Grade Increase (WRI/WGI), Appointment, or Separation showing you are/were in the competitive service and the highest grade or promotion potential held. SF-50 submitted cannot be an annual pay adjustment or award. Your SF-50 must show the following information:

Full position title;

Appointment type;

Pay Plan, Series, Grade & Step;

Tenure code; and

Service Computation Date (SCD).

Learn more on the USAJOBS SF-50 Help Page .

Veterans & Military Spouses:
You must submit a DD-214 form (Certificate of Release or Discharge) that has the dates of service and discharge status.

• Active Duty Members: To claim status Under the VOW (Veterans Opportunity to Work) to hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• Parents of Deceased or Disabled Veterans: To claim status under Gold Star Fathers Act of 2015, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Widow or Widower: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Spouse of a Living Veteran: To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.

See Feds Hire Vets or USAJOBS' Veterans page for more details.

People with Disabilities (Schedule A):
Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. Learn more on the USAJOBS Individuals with Disabilities Site .

Displaced employees:
If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site .

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.