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 is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States. 

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 mission of the Office of Biostatistics and Pharmacovigilance (OBPV) involves evaluating the safety and efficacy of the spectrum of CBER products throughout their entire lifecycle, from preclinical to post-marketing. OBPV scientific disciplines include experts in epidemiology, statistics, medicine, risk analysis, public health, genomics, and other scientific areas. 

The OBPV CBER Surveillance Program Staff works collaboratively with OBPV and CBER staff to identify key post-market safety and effectiveness questions for biologics to be addressed by Sentinel studies. CBER Surveillance Program Staff coordinates and formulates the design of appropriate studies and analytic plans. The CBER Surveillance Program Staff builds the infrastructure for an active surveillance system of biologics using large-scale administrative claims and electronic health record data from a variety of sources. 

Duties/Responsibilities 

The incumbent serves as a Project Manager for the CBER Surveillance Program Staff in the Immediate Office of the Director (IOD) within the Office of Biostatistics and Pharmacovigilance (OBPV). This position reports to the CBER Surveillance Program Staff Lead. The CBER Surveillance Program Staff Project Manager serves as a focal point for information, operations, program policy, surveillance projects, and implementation issues that require management and coordination for the Biologics Effectiveness and Safety (BEST) Initiative. The CBER Surveillance Program Staff Project Manager works with the CBER Surveillance Program Staff to manage all CBER Surveillance Program Staff projects throughout the full project life cycle, including the planning, budgeting, requirements development, design, development, risks and risks mitigation strategies and implementation phases.  

Specifically, the Project Manager will:  

• Work with CBER staff in developing strategies for implementing/planning for major information, operations, surveillance, and management projects, especially the implementation and operations of the BEST Program.  
• Work with CBER program staffers to identify the project scope, requirements, deliverables, and document project risks. Implement, coordinate, administer, and monitor the project plan. Formulate business practice procedures for information, operations, surveillance projects, and management within CBER. Collaborate with other BEST project managers on cross cutting projects. 
• Facilitate CBER Surveillance Program Staff meetings and work with the project leads to prepare agendas, recordings, and track meeting outcomes including decisions and action items. Update CBER Surveillance Program Staff and senior management on project status.  
• Serve as technical liaison between the BEST Contractors and the Contracting Officers by monitoring the Contractor’s performance of work, assuring technical proficiency and compliance of technical provisions and requirements of the contract, providing status updates, resolving problems as they arise, and confirming delivery of the final products and/or services under the contract.  
• Review and evaluate the Contractor’s progress related to expenditures and recommends approval/disapproval for payment as appropriate. Assist with the development of contract documents such as requests for proposals, requests for information, statements of work, independent government cost estimates and review of contract proposals.  
• Develop implementation plans for recommendations and conduct follow-up activities as appropriate to ensure that program commitments are fulfilled, and deadlines are met. Recommends and justifies changes desired in scope and/or technical provisions of the contract.  
• Facilitates interactions between various federal agencies and private stakeholders and develops and maintains a working knowledge and understanding of the issues relevant to the program. 
• Assist in developing communication plans to include tailored messages for multiple stakeholder groups regarding program objectives based on current communication channels and best practices.  
• Perform other duties as assigned. 

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 signed PMAP (if applicable), and letter of interest with “CURES CBER/OBPV/IOD/CSPS Project Manager”  in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through July 22, 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.