Information Technologist (Enterprise Architect)

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 Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

The Office of Regulatory Operations (ORO) is responsible for managing the review process and associated activities used to support CBER in facilitating the regulation and review of biological products, drugs, devices, and combination products. These responsibilities include development and governance of regulatory business processes; data standards; regulatory data analysis; program evaluation; resource utilization; user fee management; electronic submission management; and special initiatives. ORO manages CBER’s Information Technology (IT) investments throughout their lifecycle to support and ensure CBER’s review, scientific, and administrative needs are met.

Duties/Responsibilities

The Information Technologist (Enterprise Architect) of the Office of Regulatory Operations (ORO) reports to the ORO Director. The Information Technologist (Enterprise Architect) develops and facilitates the implementation of a CBER enterprise informatics architecture as captured in associated roadmaps and other documents. The incumbent provides technical understanding of information technology to business staff, technical staff and others, to drive a CBER-wide enterprise architecture modernizing CBER’s business, data and information technology. The Information Technologist (Enterprise Architect) understands business issues and needs and translates these into future state Enterprise Architecture solution. The incumbent designs a high-quality enterprise solution architecture that contributes to our IT strategic planning, IT systems and infrastructure design.

The Information Technologist (Enterprise Architect) develops and oversees the Centers enterprise architecture design strategies, models, projects and program. The incumbent supports IT modernization, by leading the effort to transform existing business capabilities contained in legacy IT systems to modern information technology solutions using an enterprise architecture approach. The Information Technologist (Enterprise Architect) leads enterprise architecture projects incorporating business processes, data management, and information technologies through the complete project life cycle.

Specifically, the Information Technologist (Enterprise Architect) will:

• Provide expert advice and guidance when technical interpretation, opinion, or decisions related to enterprise architecture and information management are solicited.
• Interpret and apply information contained within the IT architecture to inform a range of business improvement activities, particularly those involved in the design, development, enhancement, and maintenance of Center IT systems.
• Coordinate strategic activities of IT projects with appropriate contacts to ensure program operations are consistent and comply with goals and plans.
• Perform analyses on applying technologies to needed business capabilities, prepares reports or presentations outlining technical solution alternatives including risks, benefits, and costs with recommendations.
• Identify and align business, data sources and technical capabilities needed to support business capabilities and strategies.
• Create, maintain, and manage IT architecture models and their lower level components for current state and future state.
• Develop and maintain an enterprise architecture based on established EA frameworks.
• Create and manage enterprise architecture repositories using an industry recognized enterprise architecture tool such as Sparx Enterprise Architect, or Erwin EA.
• Serve as the Center liaison for industry, the Agency, the Department, and other Agencies on enterprise information management coordination.
• Monitor emerging enterprise architecture trends, and information technology trends and directions and make recommendations accordingly.
• Educate staff on the relationship between business, data, applications, and technology architectures.

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), latest PMAP (if applicable), copy of unofficial transcript(s) and letter of interest with “Title 21 CBER/ORO Information Technologist (Enterprise Architect)” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 21, 2024.

Announcement Contact

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