The Divisions of Medication Error Prevention and Analysis I and II (DMEPA), Office of Medication Error Prevention and Risk Management (OMEPRM), in the Office of Surveillance and Epidemiology (OSE) at the Center for Drug Evaluation and Research (CDER) are recruiting for professionals with a background in human factors engineering to serve as a Human Factors Evaluator at our beautiful campus in Silver Spring, MD. The successful candidate will join a multi-disciplinary team of Human Factors Evaluators responsible for the prevention and surveillance of medication errors associated with biological and drug products, including combination products.
As a Human Factors Evaluator in CDER, you can make a difference in protecting the health of the American people. CDER serves as the consumer watchdog of America’s healthcare system by making sure that safe and effective drugs are available to improve the health of consumers and that prescription and over-the-counter drugs, both brand and generic, work correctly and that the health benefits outweigh known risks.
Human Factors Evaluators serve as specialists in human factors and behavioral studies to support CDER’s scientific review programs and activities. This includes:
Leading discussion on specific human factors and behavioral issues including human factors analysis, evaluation and testing, product and/or medical device user needs, patient preferences, and use errors.
Assures human factors scientific reviews are incorporated into final assessments.
Duties may include but are not limited to:
Determine the human factors data and information needs for individual medical products based on information provided from the Sponsor/Applicant
Reviews design of human factors validation testing protocols for their ability to generate data that are useful and adequate to determine a product’s user interface has been optimized to support safe and effective use
Reviews comparative-use human factors study protocols
Provides advice to the sponsor on the design of human factors validation testing protocols
Reviews human factors validation testing results and comparative-use human factors testing results
Evaluates risk analyses, comparative analyses and human factors/usability development and testing plans and data submitted to support pre- and post-market reviews of a variety of medical products
Works with a multidisciplinary team to evaluate pending medical products
Produce written deliverables to document outcomes of assessments of sponsor submitted human factors data and information
Salary & Benefits: An excellent benefits package with health insurance, life insurance, thrift savings plan, retirement.
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.
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.
Specialized Experience Requirement: Have one year of specialized experience, equivalent to the GS-12 grade level or equivalent band level of responsibility in the Federal service with expertise in the processes involved in planning, conducting, and evaluating human factors investigations and tests.
This position is located in Silver Spring, MD.
This advertisement is for a full-time position.
BASIC EDUCATION REQUIREMENTS:
Degree: Bachelor’s or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.
Degree: behavioral or social science; or related disciplines appropriate to the position.
Combination of education and experience that provided the applicant with knowledge of one or more of the behavioral or social sciences equivalent to a major in the field.
Four years of appropriate experience that demonstrated that the applicant has acquired knowledge of one or more of the behavioral or social sciences equivalent to a major in the field.
Degree: Engineering. To be acceptable, the program must: (1) lead to a bachelor’s degree in a school of engineering with at least one program accredited by ABET; or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics; (d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties); and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics.
Combination of education and experience -- college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering.
Division of Medication Error Prevention and Analysis (DMEPA I & DMEPA II)
As part of the FDA preapproval process for new drug products, we review proposed proprietary drug names, container labels and other labeling, packaging, product design, and human factors submissions to prevent medication errors. We also review medication error reports submitted to the FDA Adverse Event Reporting System (FAERS) and work collaboratively with the Division of Mitigation Assessment and Medication Error Surveillance to investigate and determine if regulatory actions such as labeling revisions or product redesign are needed to address reported errors. We also collaborate with external stakeholders, regulators, and researchers to understand the causes of medication errors and the effectiveness of interventions to prevent them, and provide guidance to industry on drug development considerations to prevent medication errors.