Information Technologist (IT Project Manager)

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.

ORO, DIT, Program Management & Analysis Branch (PMAB) is responsible for CBER activities regarding planning and evaluation of programs, functional activities, and resource utilization related to regulatory review and governance of regulatory, information technology (IT), data and other regulatory operations. ORO manages the CBER Managed Review Process, maps processes develop guidance, regulations, standard operating procedures, job aids, and tools associated with the regulatory review process. Promotes and coordinates the development and management of regulatory data standards for review of regulatory submissions and represents CBER in several areas of national and international data standards formulation/implementation. DIT works with the CBER managers and staff in carrying out activities and projects related to meeting the Center's specific IT goals by providing a high level of support to CBER customers while effectively managing IT change. This position is at the GS-2210-14 full performance level.

Duties/Responsibilities

The incumbent serves in the Program Management & Analysis Branch (PMAB), Division of Information Technology (DIT) in ORO.

Specifically, the Information Technologist (IT Project Manager) will:

• Participate in oversight of CBER IT projects that encompass all aspects of Center operations and are intended to optimize and modernize the various CBER Regulatory Review legacy systems and reduce the number of systems a CBER Reviewer needs to use while providing more user-friendly IT tools.
• Leads in efforts to develop policies and procedures and implement process improvements to enhance the efficiency and effectiveness of DIT/PMAB operations.
• Participate in reviews and assessments throughout the PMAB with primary focus on the following areas: IT Program Management, contract management and oversight, IT contract creation and oversight, communications management, adherence to DIT standards, data oversight and planning, and Independent Verification and Validation (IV&V).
• Develop, recommend, coordinate, and implement PMAB program wide processes promote standardization, minimize risks and improve DIT work quality.
• Develop, Maintain, and revise the Quality Management Plan, Risk Management Plan, applicable documentation, and SOPs to incorporate process improvements and updates to the IT program and IT systems.
• Help manage IT project risk & issues.
• Review IT projects for consistency and adherence with the regulations and CBER IT procedures and standards.
• Support CBER IT Project Managers and stakeholders in planning and executing projects, during all phases of the HHS Enterprise Lifecycle Project management (EPLC).
• Verify that IT Project deliverables meet standard and help with remediations as necessary, as well as updating documents and templates to reflect identified process improvements.

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), copy of unofficial transcript(s), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/ORO/DIT/PMAB Information Technologist (IT Project Manager) in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through 9/27/24.

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.