Title 21 Vacancy Announcement

U.S. Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

Office of Strategic Partnerships and Technology Innovation (OST)

Application Period: March 27, 2024 April 26, 2024

Area of Consideration: United States Citizenship is required. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Information Technologist (Program Manager)

Series: AD-2210

Location(s): Remote Eligible

Salary: Salary is commensurate with education and experience and starts at $139,395.00

Work Schedule: Full-Time

Cures Band(s): Band D

Full Performance Band Level: Band D

Travel Requirements: Less than 25%

Supervisory: No

Relocation Expenses Reimbursement: No

Bargaining Unit: 3591

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:

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 Devices and Radiological Health is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. The (OST) provides leadership for all scientific collaborative and emerging technology related activities at CDRH. We represent CDRH with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products.

Duties/Responsibilities

The Information Technologist serves as a technical authority and subject matter expert for the CDRH business process. The incumbent leads, coordinates, communicates, integrates and is accountable for the overall success of the program, ensuring alignment with critical agency priorities. Ensure that work efforts achieve the outcome specified within the agency s business strategy, including appropriate strategic, lifecycle management and capital IT investment plans. Work includes project selection, prioritization, evaluation and monitoring, cost schedule management, risk management, quality management and resource allocations.

Independently performs work in the administration, development, delivery and support of IT systems and services for the Center. Leads the development and direction of CDRH s digital transformation and data modernization efforts, projects, and programs, ensuring alignment with the Center s Information Technology (IT), business services, and data strategy development. The efforts will aid in streamlining the systems that manufacture and review staff use to facilitate safe and effective medical devices are available to the US public in a timely manner.

Provides integrated program and product management by ensuring investment justification or business case development, solution analysis, resource management, performance monitoring and adapting plans and future responses to address feedback. Communicates formally and informally through existing forums to stakeholders at all levels, including senior management. Leads program meetings with cross functional team to communicate the status of various program activities, discuss issues/risks, and understands the impact of any changes to business requirements. Enables strategic approaches for creating consensus with CDRH governance regarding major initiative project plans and funding streams ensuring alignment of IT with the organization s operations and initiatives.

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, candidates must meet the following criteria:

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

In order 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: A bachelor s degree or higher in a computer science, cybersecurity, information science, information systems management, technology, engineering field. The degree must be from an accredited program or institution.

OR

Experience: Experience requirements include at least one of the following:

• Experience that demonstrates knowledge of the software design, development, and testing lifecycle.
• Experience that demonstrates knowledge of enterprise architecture, business architecture, systems architecture, service-oriented architecture, or data architecture, or frameworks of the same.
• Experience that demonstrates knowledge of IT management, IT helpdesk support, system integration, IT project management, IT Finance, or IT Acquisitions.
• Experience that demonstrates knowledge of managing IT transformation programs, managing IT innovation programs, or implementing disruptive technologies.
• Experience that demonstrates basic knowledge of technology and data processing functions, data extraction, transformation, loading, automation, and other aspects of data management.
• Demonstrated ability to meet the standards of a skills assessment test to be administered by the agency during the candidate process (i.e., pre-employment).
• Experience that demonstrates knowledge of the user experience design, development, and testing lifecycle.

Experience may have been gained in work such as CIO/CTO/other IT executive, IT manager, IT services manager, enterprise transition manager/planner, enterprise architect, business analyst, systems integrator, systems administrator, programmer, program analyst, or other positions that required the management of, use, or adaptation of computer programs and systems.

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 .

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Public Trust/Moderate Risk

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 the 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: .

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.

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 or

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 and unofficial transcripts by April 26, 2024, to: . 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 . Please reference Job Reference ID: CDRH/OST/IO Information Technologist PBM-5365

Announcement Contact

For questions regarding this Cures position, please contact .

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.