Duties

Summary

This position is located in the Center for Drug Evaluation and Research (CDER), Office of Medical Policy Initiatives (OMPI), Division of Medical Policy Programs.

Current permanent employees of the Food and Drug Administration (FDA) may apply if serving on a career or career conditional appointment.
Learn more about this agency

Responsibilities

• Reviews and evaluates patient labeling and other materials for prescription and non-prescription drug products.
• Initiates and leads efforts to assure timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving goals.
• Acts as liaison between the Office and other agency units, including review divisions, and participates in negotiations with firms as appropriate.
• Mentors and provides training for junior patient labeling reviewers and others within Center for Drug Evaluation and Research (CDER).
• Compares the patient labeling to the professional labeling to ensure consistency in content and that FDA requirements are consistently and equitably applied.
• Develops class language templates and advises review divisions regarding language for patient information related to proposed safety labeling changes.

Travel Required

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

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.

Qualifications

The position of Senior Patient Product Information Specialist falls within the 0601 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements at the GS-13 by 11:59 pm EST on 09/28/2020.

Basic Requirements:

You must have a bachelor's or graduate/higher level degree in a 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 (external link) at the time the degree was obtained.

AND

Minimum Qualification GS-14:

Applicant must have one (1) year of specialized experience, equivalent to the GS-13 in the Federal service to that includes experience: overseeing/managing the content of patient drug labeling and other materials of prescription drug products in accordance with FDA requirements and communicating drugs and medical information to patients. ( This experience must be documented in your resume )


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 assign ment.

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.

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. Your uploaded documents may take several hours to clear the virus scan process.

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 internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details...

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
• If you are serving, or have served in the last 5 years (from 09/28/2020) 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 (09/28/2020); 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, you agree 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 09/28/2020), 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 two categories: Best Qualified or Qualified.

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.

Planning and Evaluation

Written and Oral Communication

Problem Solving

To preview the application questionnaire, click the link below.
https://apply.usastaffing.gov/ViewQuestionnaire/10900354

Background checks and security clearance

Security clearance
Not Required

Drug test required
No

Required Documents

REQUIRED DOCUMENTS:

• Resume
• SF-50/ Notification of Personnel Action
• 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
• 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 & Former Federal Employees:
You will need to submit the following:

PLEASE NOTE : To properly verify status eligibility (please submit an SF-50 that shows our eligibility to apply as an FDA employee), and to verify 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.

Full position title

Service Computation Date (SCD)

Tenure code; and Pay plan, series, grade, and step

Occupational series

Appointment type

Please ensure your SF-50 includes the information above or your eligibility and Time-in-Grade cannot be verified. Your performance appraisal is not required at the time that you submit your application. If you receive an interview and your performance appraisal is requested, you should submit your most recent performance year on file, and it should show the signature and rating.

CTAP:
If you are a former HHS 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 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.