Health Science Project Manager

Employer
USAJobs
Location
Silver Spring, Maryland
Posted
Jan 19, 2021
Closes
Jan 26, 2021
Hours
Full Time
Duties

Summary

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Program & Regulatory Operations (OPRO), located in Silver Spring, MD.
Learn more about this agency

Responsibilities

  • Perform substantive activities related to the administration, execution, coordination, and tracking of project activities associatedwith compliance issues and initiatives for compliance-specific program areas.
  • Assist in the development of statutorily mandated reports on compliance-specific programs and ensures their timely submissionto Center/Agency management or Congress.
  • Participate in, and effectively contributes to, Center-level and inter-Center level discussions and meetings on the formulation and development of policy related to compliance-specific programs.
  • Develop and implement programs and initiatives to support the Center's policies associated with above regulatory program areas.


Travel Required

Not required

Supervisory status
No

Promotion Potential
14

Requirements

Conditions of Employment

  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Applicants must have at least a fully successful or equivalent performance rating to receive further consideration for this position.
  • A probationary period may be required.


Qualifications

The position of Health Science Project Manager falls under the
0601 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 01/26/2021.


Applicants must meet both the basic and minimum qualification requirements.

Basic Requirement : Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (https://ope.ed.gov/accreditation/) at the time the degree was obtained.

AND

Minimum Qualifications :Applicant must have at least one year of specialized experience, equivalent to at least the GS-13 level in the Federal service that include 1) Managing and leading program operations related to public health regulatory programs and 2)Evaluating public health program performance. Volunteering expereince can be used as qualifying experience.

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. You will receive credit for all qualifying experience, including volunteer experience.

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!

Who May Apply:- Federal employees with career or career-conditional appointments in the competitive service;
- Former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments;
- Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) or the Interagency Career Transition Assistance Program (ICTAP);
- Veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service;
- Military Spouses;- PHS Commissioned Corps Officers;- Individuals eligible for VEOA appointments (at the GS-11 and above grade levels);
- Individuals with disabilities who quality for a Schedule A appointment.

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.

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

Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university.
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .

SUBMITTING YOUR TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. 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.

Additional information

ADDITIONAL CONDITIONS OF EMPLOYMENT:

We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
  • Pre-employment physical required: No
  • Drug testing required: No
  • License required: No
  • Mobility agreement required: No
  • Immunization required: No
  • Bargaining Unit Position: Yes (3591)
  • If you are serving, or have served in the last 5 years (from 01/26/2021) 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
All requirements must be met by the closing date of this announcement (01/26/2021); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.

Additional selections may be made within the same geographical area FDA-wide.

How You Will Be Evaluated

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

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, youagree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 01/26/2021), a review 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 this internal position. Eligible internal candidates will be referred to the hiring official for consideration.

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.

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.

Career Transition Assistance Program (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 medical 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 do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
  • Project Management
  • Compliance
  • Oral Communication
  • Written Communication
  • To preview the application questionnaire, click the link below.
    https://apply.usastaffing.gov/ViewQuestionnaire/10991577


    Background checks and security clearance

    Security clearance
    Other

    Drug test required
    No

    Position sensitivity and risk
    Moderate Risk (MR)

    Trust determination process
    Suitability/Fitness

    Required Documents

    REQUIRED DOCUMENTS:
    • Resume
    • Transcript

    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
    • 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 & Former Federal Employees:

    PLEASE NOTE: To properly verify status eligibility, and Time-in-Grade, please submit your last promotion SF-50, or your last grade/step increase SF-50 of your highest grade held, and ensure that your competitive status, tenure, SCD, and highest grade held are shown. If you do not submit an appropriate SF-50, we cannot verify your status eligibility or Time-in-Grade. You may submit multiple SF-50's.

    Please DO NOT submit an Award SF-50 or General Adjustment (Gen Adj) SF50.

    1. Full position title;
    2. Appointment type;
    3. Occupational series;
    4. Pay plan, series, grade, and step;
    5. Tenure code; and
    6. Service Computation Date (SCD). Please ensure your SF-50 includes the information above or your eligibility and Time-in-Grade cannot be verified.

    Please ensure your SF-50 includes the information above and it shows your last promotion or grade / step increase, and ensure that your competitive status, tenure, SCD, and highest grade held are shown. 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 (CTAP/ICTAP): 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. 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.

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