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 Strategic Programs (OSP)

Office of Business Informatics (OBI)

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 compensated 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.

Application Period: January 19, 2024 - April 19, 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.

Position: Computer Scientist Series: AD-1550

Location(s): Silver Springs, MD

Work Schedule: Full-Time

Salary:

$82,764 - $109,506 (Band A)

$99,200 - $133,845 (Band B)

$117,962 - $164,260 (Band C)

Cures Band(s): Band A/B/C Full Performance Band Level: Band C

Travel Requirements: 25% or less

Bargaining Unit: 3591

Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation 

expenses in accordance with agency policy.
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The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential 

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 (OTC) and prescription 

drugs, including biological therapeutics and generic drugs. 

The Office of Strategic Programs (OSP) is responsible for quantitative and qualitative data 

analysis, program evaluation, business process modernization, decision support services to 

facilitate effective operations, consultation to Center Offices in developing strategic and 

operational plans for CDER, cross-center management and coordination of work on Centerwide governance and special initiatives, and the implementation of IT solutions to meet CDER’s 

business needs. OSP provides essential expert support and enabling services for CDER to meet 

its mission objectives.

The Office of Business Informatics (OBI) supports CDER’s regulatory decision-making by 

identifying, implementing, and managing CDER-wide informatic systems to meet business 

needs. OBI collaborates with CDER stakeholders to modernize and continually improve CDER's 

business operations with state-of-the-art tools to facilitate activities related analysis, 

management, performance tracking, and execution of the Center’s regulatory commitments 

while continuing to protect public health. Additionally, OBI develops analytic approaches and 

conducts analyses for regulatory operations to inform CDER's strategy and policy position on 

emerging trends and streamline review operations.

This position is located in the Division of Business Management Services and Solutions (DBMSS), 

Office of Business Informatics (OBI).

Duties/Responsibilities

• As a Computer Scientist, the incumbent works to meet mission-critical informatics 

initiatives in support of CDER’s regulatory operations by assisting in the development of 

software systems that form the basis of the modern computing environment for 

scientific review of human drugs and therapeutic biologics. Participates in the 

requirements analysis of architecture solutions and products for big data, research and 

scientific analysis that are aligned with industry best practices.

• Responsible for ensuring successful on-time delivery of informatics projects and 

effective planning for lifecycle maintenance to support Prescription Drug User Fee 

Amendments (PDUFA), Generic Drug User Fee Amendments (GDUFA), and Over-theCounter Monograph User Fee Amendments (OMUFA) regulatory activities. 

Band A

• Works with the supervisor or senior staff to design and deliver architecture solutions 

and software applications for research and scientific analysis that are aligned with the 

latest industry trends and standards for the implementation of electronic submissions, 

workflow management, and data analytics tools. Assists with the design and 
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implementation of analytics tools to facilitate the regulatory decision-making for premarket review and post-market surveillance. 

• Assists with technical support needs and collaborates closely with peers, scientists, and 

engineers (including the CDER community) to solve computing assigned problems.

• Works with senior computer scientist or senior specialists to identify and report on 

technical trends and techniques and apply them to the development of solution design.

• Assists with the provision of Information Technology (IT) project management support 

for technical projects by working with project leads to plan, organize, and implement 

technical projects. 

• Assist project lead coordinate production releases and rollouts. Work with project lead 

to identify task to delegate contractors and collaborate with project lead to present on 

project’s progress and results.

Band B

• Meets duties and responsibilities outlined in Band A above.

• Contributes to the design and delivery of architecture solutions and software 

applications for big data, research and scientific analysis that are aligned with the latest 

industry trends and standards for the implementation of electronic submissions, 

workflow management, and data analytics tools. Participates in the design and 

implementation of analytics tools to facilitate the regulatory decision-making for premarket review and post-market surveillance.

• Provides technical support and collaborates closely with regulatory staff and software 

engineers to solve computing problems for easily solvable workstreams.

• Applies scientific computing techniques to computationally intensive tasks that are 

encountered in research and management applications.

• Collaborates with technical and subject matter expert, to design, develop and/or modify 

existing software to help solve routine, novel, and difficult scientific computing 

problems.

• Collaborates with technical and subject matter expert, provides Information Technology 

(IT) project management support for technical projects by planning, organizing, and 

implementing technical projects. Coordinate production releases and rollouts. Works 

with the supervisor on tasking the necessary contracting team and presenting on 

project’s progress and results.

Band C

• Meets duties and responsibilities outlined in Band B above.

• Designs and delivers architecture solutions and software applications for big data, 

research and scientific analysis that are aligned with the latest industry trends and 

standards for the implementation of inbound management, information management, 

electronic submissions, workflow management, and data analytics tools. Coordinates 

the design and implementation of analytics tools to facilitate the regulatory decisionmaking for pre-market review and post-market surveillance.
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• Analyzes business and IT challenges in regulatory operations and designs a 

comprehensive solution that integrates effectively into the scientific computing 

environment. 

• Applies scientific computing techniques to computationally intensive tasks that are 

encountered in research and management applications.

• Designs, develops and/or modifies existing software to help solve routine, novel, and 

difficult scientific computing problems.

• Independently provides Information Technology (IT) project management for complex 

technical projects by planning, organizing, and implementing technical projects. 

Coordinate complex production releases and rollouts. Delegating Works with the 

supervisor to delegate multiple tasks to the necessary contractors and presenting on 

project’s progress and results.

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 

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 
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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: 

Computer Scientist, AD-1550 Series 

Degree: A bachelor's degree or higher in mathematics, statistics, computer science, data 

science, information systems, software engineering, or computer engineering. The degree must 

be from an accredited program or institution.

OR

Experience: Relevant work in designing, analyzing, or developing computer systems, may also 

include the application of mathematical and statistical sciences to computer system design and 

development.

Specialized Experience: N/A

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 U.S. Department of 

Education website for Foreign Education Evaluation.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Non-Sensitive/Low Risk (A/B) or 

Medium Risk (C) 

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 
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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 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 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.
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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 and transcripts by April 19, 2024, to: 

CDEROSPRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official 

within the Center for Drug Evaluation and Research (CDER) with a similar job vacancy. 

Candidates can opt out of this process by annotating resume with “do not share”. For

questions, please contact CDER OSP Recruitment Team at CDEROSPRecruitment@fda.hhs.gov.

Please reference “Computer Scientist and OBI -DBMSS” in the subject-line when applying or 

submitting questions. 

Announcement Contact

For questions regarding this Cures position, please contact CDEROSPRecruitment@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.