FDA 21 Vacancy Announcement User Guide

: June 15, 2024
: FDA

Table of Contents

FDA 21 Vacancy Announcement
Product Information
U.S. FOOD & DRUG ADMINISTRATION
Introduction
Conditions of Employment
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

FDA 21 Vacancy Announcement

Product Information

Specifications

Position : Deputy Office Director
Series : AD-0602
Location(s) : Silver Spring, Maryland
Work Schedule : Full Time
Cures Band(s) : Band F
Salary : Starting at $210,000
Full Performance Band Level : Band F
Travel Requirements : 25% or less
Bargaining Unit : 8888
Relocation Expenses Reimbursement : Will NOT be paid

Introduction
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.

Duties/Responsibilities
As Deputy Office Director, the incumbent supports the Office Director, providing executive leadership and direction to the Office’s subordinate Divisions.

Conditions of Employment
To be placed into a Cures position, candidates must meet the following criteria

Scientific, Technical, and Professional Fields
Qualified and Outstanding Candidates

Qualified Candidates
Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.

Outstanding Candidates

Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note : Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the desired criteria will not be excluded from consideration for this position.

Education Requirement

Deputy Office Director, AD-0602 Series. For more information,
please see : OPM Occupational Series Qualification Requirements.

Product Usage Instructions

Step 1: Review Position Details
Review the specifications of the Deputy Office Director position, including the series, location, work schedule, salary, travel requirements, bargaining unit, and relocation expenses reimbursement.
Step 2: Understand the Role of FDA
Understand that the FDA is responsible for ensuring the safety and effectiveness of various products, including drugs, medical devices, cosmetics, foods, and tobacco.
Step 3: Familiarize Yourself with Duties/Responsibilities
As Deputy Office Director, your main responsibility is to support the Office Director and provide executive leadership and direction to the Office’s subordinate Divisions.
Step 4: Meet the Criteria for Cures Position
Ensure that you meet the criteria for a Cures position, which include having a background in scientific, technical, or professional fields and being a qualified and outstanding candidate.

Qualified Candidates
Make sure you meet the basic requirements defined in the OPM Qualification Standards.

Outstanding Candidates
Showcase your outstanding work experience and/or outstanding performance rating.

Step 5: Review Education Requirement
For the Deputy Office Director, AD-0602 Series, review the OPM Occupational Series Qualification Requirements for more information on the education requirements.

FAQ

Q: What is the role of the FDA?
A: The FDA is responsible for ensuring the safety and effectiveness of various products, including drugs, medical devices, cosmetics, foods, and tobacco.
Q: What are the qualifications for a Cures position?
A: To qualify for a Cures position, you need a background in scientific, technical, or professional fields. Additionally, being a qualified and outstanding candidate is preferred.
Q: Are relocation expenses reimbursed for the Deputy Office Director position?
A: No, relocation expenses will not be paid for this position.

U.S. FOOD & DRUG ADMINISTRATION

Title 21 Vacancy Announcement
U.S. Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology (OSE) Office of Pharmacovigilance and Epidemiology (OPE)

Application Period : July 28, 2023 – August 10, 2023
Area of Consideration : United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Position : Deputy Office Director
Location(s) : Silver Spring, Maryland Work Schedule : Full Time
Cures Band(s) : Band F
Travel Requirements : 25% or less
Bargaining Unit: 8888
Relocation Expenses Reimbursement: Will NOT be paid.
Series : AD-0602
Salary : Starting at $210,000
Full Performance Band Level : Band F

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. Additional information on 21st Century Cures Act can be found here

21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC). CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
The Office of Surveillance and Epidemiology (OSE) within CDER works to detect, assess, prevent, and manage the risks of medications so that they can be relied on to treat disease and improve health. OSE participates in the safety analysis of drugs before they are marketed to patients and consumers and utilize risk assessment tools to identify and assess adverse events and medication errors that did not appear during the drug development process.
The Office of Pharmacovigilance and Epidemiology (OPE) is responsible for identifying and evaluating safety concerns for drugs and therapeutic biologics and for using epidemiologic evidence to assess the effectiveness of drugs and the therapeutic biologics. OPE recommends actions to improve patient safety and protect and promote the public health. The Drug Safety Team (DST) supports the therapeutic areas anesthesia, addiction, pain, and psychiatry. The mission is to evaluate the safety of marketed drugs.

Duties/Responsibilities
The Deputy Office Director participates fully with the Office Director and Super Office Director in planning, managing, organizing, and directing all of the post-market operations, program, functions and activities of the staff as carried out by subordinate supervisors/team leaders and a highly trained and skilled staff of health professionals, medical doctors, epidemiologists, pharmacists, social science researchers and health writers/communicators, organized into subordinate organizations. The Division of Epidemiology-II (DEPI-II) and the Division of Pharmacovigilance-II (DPV-II) report to the Deputy Office Director.

Assists the Office Director in reviewing office requests for funds and personnel, evaluates budget estimates and justifications, and makes appropriate recommendations to the OSE Director. Directs budget for staff, which includes medical, scientific, administrative, and support personnel assigned to the divisions.
Provides clinical, scientific, technical, and administrative direction and supervision 25% or more of the time to subordinate supervisors, team leaders and staff performing the work and functions of the organizational unit.
Obtains resources and identifies strategic objectives for the organization. Provides authoritative and professional expertise in health sciences, including epidemiology, and population health issues related to the regulation of drugs and therapeutic biological products and serves as expert adviser and technical authority on analyzing, advising, and resolving complex and precedent-setting policy and program issues. Is responsible for developing policies, strategies, and plans to address cross-cutting population health issues.
Serves as scientific lead and leads special projects and initiatives, for example signal identification and guidance development.
Participates plans, manages, and directs all postmarked operations, programs, functions, and activities of the staff as carried out by subordinate supervisors, team leaders, and highly trained and skilled staff of health professionals, physicians, epidemiologists, pharmacists, and other multi-disciplinary health care professionals organized into subordinate divisions. The OPE divisions are responsible for management and research of drug safety analysis and drug safety data bases including FDA Adverse Event Reporting System (FAERS) and external databases. In conjunction with other CDER offices, OPE divisions are also responsible for disseminating postmarked information to the public and other health professionals.
Along with the OPE Office Director, provides critical reviews in the study design and methods of epidemiological study protocols relevant to the assessment of post-marketing drug safety submitted by the pharmaceutical industry. Additionally, the incumbent reviews and analyzes epidemiological study reports and datasets relevant to the assessment of post-marketing drug safety that are submitted to the FDA.

Supervisory Responsibilities : As Deputy Office Director, the incumbent supports the Office Director, providing executive leadership and direction to the Office’s subordinate Divisions.

Conditions of Employment

U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
Applicants must meet all qualification requirements by the closing date of this announcement.
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.
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.
Males born after December 31, 1959 must be registered with the Selective Service.
Financial Disclosure may be required.
Ethics Clearance may be required.
Background Investigation/Security Clearance is required. 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.

Qualifications
To be placed into a Cures position, candidate must meet the following criteria

Scientific, Technical, and Professional Fields
Qualified and Outstanding Candidates
- Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
- Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note : Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement
Deputy Office Director, AD-0602 Series
For more information, please see : OPM Occupational Series Qualification Requirements.

Professional Experience
Our ideal candidate will possess

Ability to understand, review and synthesized data from a variety of sources (e.g., FAERS, observational studies, clinical trials).
Identification and assessment, understanding of risk management and epidemiology.
Background/experience in epidemiology; public health preferred.
Knowledge of Agency Procedures, related regulations of the Food Drug and Cosmetic (FD&C) Act, and the Regulatory Procedures Manual.
Strong clinical and leadership skills, and a collaborative spirit.
Ability to communicate scientific information orally and in writing.
Highly organized.
Healthcare professional licensure (e.g., MD, DO, PharmD, Nurse Practitioner (NP), Physician’s Assistant (PA).

Desired Professional Experience
Our ideal candidate will possess drug safety experience.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS : Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify education alachievement. 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 FDA employee, you are not exempt from transcript requirements.

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.

Security Clearance Requirements
Background Investigation/Security Clearance Requirements: Non-Sensitive/High Risk
If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required later.
Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non- selection and/or appropriate disciplinary action.

Ethics Clearance Requirements
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 .

Equal Employment Opportunity
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants.

Reasonable Accommodation
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office- sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify
The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.

How to Apply
Submit resume with cover letter by August 10, 2023 to OSE-PMAS-Admin- Team@FDA.HHS.gov. Candidate resumes may be shared with hiring officials within the Center for Drug Evaluation and Research with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.
Please reference Job Reference ID : OMEPRMDOD0823 on the email subject line.

Announcement Contact
For questions regarding this Cures position, please contact OSE-PMAS-Admin- Team@FDA.HHS.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.