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: January 22, 2024 – February 2, 2024

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. 

Commissioned Corp Officers are eligible to apply. Appropriate for an O-5 Billet.

Position: Lead General Health Scientist 

(Team Leader)

Series: AD-0601 

Location(s): Silver Spring, MD

Work Schedule: Full Time

Salary: Starting at $132,368

Cures Band(s): Band D Full Performance Band Level: Band D

Travel Requirements: 25% or less

Bargaining Unit: (8888)

Relocation Expenses Reimbursement: Will not be paid

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 safe, and effective.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential 
2

public health task by making sure that safe and effective drugs are available to improve the 

health of people in the United States. CDER regulates over the counter and prescription drugs, 

including biological therapeutics and generic drugs.

The mission of the Office of Surveillance and Epidemiology (OSE) is to detect, assess, prevent, 

and manage the risks of medications so that they can be relied upon to treat disease and 

improve health using four core functions: Pharmacovigilance, Pharmacoepidemiology, Risk 

Management, Medication Error Prevention and Analysis.

The mission of the respective divisions in the Office of Pharmacovigilance and Epidemiology 

(OPE) is to protect the public using epidemiologic evidence to assess the safety and 

effectiveness of drugs and biologics by detecting, assessing, and evaluating the safety and

effectiveness of drugs and biologics using observational methods; and conducting drug and 

biologic safety and effectiveness surveillance and research using the best available 

epidemiologic methodologies. This position is in the Division of Epidemiology I (DEPI I), Office of 

Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE), 

Center for Drug Evaluation and Research (CDER). 

Duties/Responsibilities

As a Lead General Health Scientist, the incumbent is responsible for serving as advisor 

planning, coordinating, and evaluating drug safety and effectiveness programs and activities to 

assess risk and treatment effect using real-world data. 

• Reports to the supervisor on team and individual work accomplishments, problems, 

and work processes.

• Coordinates team initiatives and policy implementation. Prepares reports and 

maintains records of work accomplishments and supporting information. Represents 

the team in dealings with the supervisor and manager to obtain resources and secure 

information for decisions.

• Applies a wide range of qualitative and quantitative methods to analyze and improve 

team effectiveness. Leads the team in assessing its strengths and weaknesses; resolves 

simple and informal complaints of employees and refers others to an appropriate 

management official.

• Maintains close personal contact with the “state of the science” in order to inculcate 

the most advanced theories and practices in the programs.

• Serves as a recognized authority in the area of scientific expertise, receives for 

resolution unique, far-reaching, and previously unresolved problems.

• Provides consultations, opinions, and endorsements regarding the area of regulatory 

expertise and attends meetings both within and outside the Federal government.

• Addresses professional groups, such as Pharmaceutical Research and Manufacturers of 

America (PhRMA) Foundation and Advanced Medical Technology Association 

(AdvaMed), on the area of regulatory expertise as that area affects the mission for 

which the Division/Staff is responsible.
3

Team Leader Functions: 

• Leads a team of a minimum of four.

• Ensures that the organization’s strategic plan, mission, vision, and values are 

communicated and integrated into the team’s strategies, goals, objectives, and work.

• Articulates and communicates to the team the assignment, project, problem to be 

solved, actionable events, milestones, and/or program issues under review, and 

deadlines and time frames for completion.

• Coaches the team in the selection and application of appropriate problem-solving 

methods and techniques, provides advice on work methods, practices, and procedures, 

and assists the team and/or individual members in identifying the parameters of a 

viable solution.

• Leads the team in identifying, distributing, and balancing workload and tasks among 

employees in accordance with established workflow, skill level and/or occupational 

specialization; adjusting the workload in accordance with established priorities to 

ensure timely accomplishment of assigned team tasks and ensures that each employee 

has an integral role in developing the final team product.

• Provides input on the training needs of team members and works with division 

management to arrange specific administrative and/or technical training to accomplish 

tasks or projects.

• Monitors and reports on the status and progress of work, checking on work in progress 

and reviewing completed work to see that the supervisor’s instructions on work 

priorities, methods, deadlines, and quality have been met.

• Serves as facilitator in coordinating team initiatives and in consensus building activities 

among team members.

• Maintains current knowledge to answer questions from team members on procedures, 

policies, and directives, etc.

• Facilitates problem solving methods and techniques within team.

Supervisory Responsibilities: N/A

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 
4

arises, you must take affirmative steps to resolve the matter.

• Males born after December 31, 1959, must be registered with the Selective Service.

• One-year supervisory probationary period may be required. 

• 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, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. 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.

b. 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:

General Health Scientist, AD-0601 Series

For more information, please see OPM Occupational Series Qualification Requirements.

Desired Education:

Our ideal candidate will possess a 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 theU.S.Departmentof Education at the time degree is obtained. 

Desired Professional Experience: 

Our ideal candidate will possess:

• Knowledge of the FDA Amendments Act, and the regulations and policies promulgated under 

that statute.
5

• Advanced knowledge of science (e.g., biology, regulatory science, drug safety, 

pharmacoepidemiology).

• Demonstrated ability to clearly communicate orally and in writing. 

• Skill in working with a variety of people at all levels. Demonstrated ability to develop

networks and build alliances; collaborates across boundaries to build alliances, collaborates 

across boundaries to build strategic relationships, and achieve common goals.

• Skill in planning, organizing, and leading the work of other professional staff.

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 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 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 Recognition of Foreign 

Qualifications | International Affairs Office (ed.gov)

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 qualifications 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. 
6

Equal Employment Opportunity 

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of 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 accommodation to have an equal 

opportunity to apply for a job. An employee with a disability needs accommodation to perform 

the essential job duties or to gain access to the workplace. An employee with a disability needs 

accommodation to receive equal access to benefits, such as details, training, and officesponsored 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 or curriculum vitae with cover letter by February 2, 2024, to: OSE-PMAS-AdminTeam@fda.hhs.gov. Candidate resumes may be shared with hiring official within the CDER with 

a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not 

share”. For questions, please contact OSE-PMAS-Admin-Team@fda.hhs.gov. 

Please reference Job Reference ID: DEPILGHSJan24 in the email subject line. 
7

Announcement Contact

For questions regarding this Cures position, please 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.