Title 21 Vacancy Announcement

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)

Division of Technology and Data Services (DTDS)

Application Period: August 24, 2023 – September 21, 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: Business Informaticist (Data Manager)  

Series: 0301

Location(s): Remote Eligible  

Work Schedule: Full-Time

Salary: Salary is commensurate with education and experience and starts at $132,368

Cures Band(s): Band D   

Full Performance Band Level: Band D

Travel Requirements: This position requires less than 25% of travel

Bargaining Unit: 8888

Supervisory: No

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 or Agency) 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 CDRH 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 Office of Strategic Partnerships and Technology Innovation | FDA (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. 

Meet one of the faces behind CDRH here.

Duties/Responsibilities

The Business Informaticist serves as a Data Manager playing a pivotal role in building and operationalizing the infrastructure necessary for the enterprise data initiatives. This incumbent is a technical authority on the best practices, standards, processes and understand and have the ability to incorporate the use of tools and technologies which are best suited for the Center. The bulk of the Data Manager’s role will be to build, manage and optimize the data pipelines and ensure reliable movement of the data into production for reliable and trustworthy analyses. This individual will work closely with business and data analysts, business data architects, data scientists and data governance to incorporate all quality, enrichment and curation protocols and algorithms to the data for expansive use across CDRH.  This individual will also serve as a liaison between CDRH and the agency on data management issues and collaborations.  They will also advise and coordinate data activities to enhance an enterprise data solution which can serve at the agency level.

The incumbent will be the key interface in operationalizing data on behalf of all offices in the center to achieve CDRH outcomes. This role will require the ability to be both creative and collaborative in working with IT as well as the CDRH organization writ large. It will require the establishment of effective and efficient data management practices that promote a reliable, trustworthy, and transparent data asset for the Center. The incumbent will work closely with data stewards and will be responsible for overseeing the integration of CDRH data governance protocols into the data process.

The Data Manager will be expected to develop and administer data standards and data maps, including, but not limited to, the development and modification of functions, programs, routines, and other processes to Extract, Transform and Load (ETL) various data types and sets. This individual will also collaborate with IT to integrate these data into appropriate data structures and storage (both on premises and Cloud) for enterprise-wide use. They will also develop, provision, and apply automated quality procedures to ensure the data are trustworthy and of excellence for the Center. This will be done in combination and collaboration with data scientists, data analysts, data consumers and data stewards to optimize the data quality and governance for productive use.

This individual serves as a recognized authority in data warehousing, big-data-related initiatives, both within the Cloud and on-premises, data integration and implementation. They will track industry trends and recommend enterprise technologies and tools to make sure that CDRH is using the most robust and comprehensive toolset necessary for their data ingestion and integration work, as well as to help to establish these at the agency level. They will design and develop data pipelines that will be implemented in action, based on use cases and best practices. Metadata management will also be under the Data Manager’s purview as they use tools, techniques, and architectures to automate, to the extent possible, repeatable data preparation and integration tasks to minimize manual and error-prone processes and improve efficiency.  This individual will coordinate with agency data experts to ensure a collaborative and cohesive integration, as well as to impart their opinions and advice on future strategies.

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 OPM Qualification Standards 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.

How to Apply

How to Apply: Submit resume or curriculum vitae, transcripts with cover letter by September 21, 2023to CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: CDRH/OST/DTDS Business Informaticist PBM-2726

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.

Educational 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.

Conditions of Employment

• 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.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: This position requires a Public Trust security clearance.

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.

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.

Announcement Contact

For questions regarding this Cures position, please contact Courtney Miss at Courtney.Miss@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.

About Food and Drug Administration (FDA)

FDA is an agency within the Department of Health and Human Services. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

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