What are the responsibilities and job description for the Clinical Analyst position at FDA Center for Drug Evaluation and Research?
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C.
Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-medical-and-healthcare-series-0601/
General Medical and Healthcare Series, 0601, Individual Occupational Requirements
Basic Requirements:
Education: 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 at the time the degree was obtained.
Clarification from the agency regarding qualifying degrees for the General Medical and Healthcare, 0601 series: Professional work requires knowledge in a field of science or learning characteristically acquired through education or training equivalent to a bachelor's or higher degree with major study in or pertinent to the specialized field, as distinguished from general education. Work is professional when it requires the exercise of discretion, judgment, and personal responsibility for the application of an organized body of knowledge that is constantly studied to make new discoveries and interpretations, and to improve data, materials, and methods.
Medical Fields: Medicine, dentistry, podiatry, optometry, chiropractic, pharmacy and veterinary medicine. It also means applications or products for the diagnosis, treatment, mitigation or prevention of a physical or mental disease, disorder or abnormal state, or its symptoms, where such applications or products are approved by or subject to the approval of the U.S. Individuals in the medical fields are licensed professionals who have advanced or medical degrees. The term "medical" relates to or is concerned with physicians or the practice of medicine.
Health Sciences Fields: An interdisciplinary field that involves applying concepts from the natural and social sciences to health-related topics such as medicine, nutrition, environmental health, disease, and healthcare. Health sciences are those sciences which focus on health, or health care, as core parts of their subject matter. It deals with human and animal health. It also involves applying scientific research to clinical practice, in effort to improve healthcare for patients and communities. Health sciences relate to multiple academic disciplines, including, disciplines in the life sciences, physical sciences, engineering, mathematics, computer science, the health sciences, and emerging patient safety disciplines (such as social care research). Generally speaking, an undergraduate degree in health sciences prepares an individual for employment as a technician (e.g., cardiovascular technician, surgical technician, anesthesia technician, medical lab technician, veterinary technician, pharmacy technician, etc.), assistant (e.g., occupational therapy assistant, etc.), dental hygienist, paramedic, etc.
Allied Sciences Fields: Broad fields of health-care professions made up of specially trained individuals (such as physical therapists, dental hygienists, audiologists, and dietitians) who are typically licensed or certified but are not physicians, dentists, or nurses. Generally speaking, an undergraduate degree in Allied Health Sciences prepares an individual for immediate employment in a variety of health fields including case management/patient care coordination, health education, medical billing and account management, health marketing and sales, laboratory research, health insurance administration. Allied subjects are upper-division math, science, or engineering courses that have a background connection or relevance to chemistry.
Here are a few examples of how disciplines in engineering, mathematics, data science, etc. may be used in realm of health sciences. These examples are not all inclusive. For example, engineering professionals lead or participate in research and development of cutting-edge technologies for new drugs (including drug discovery, design, development, and delivery) and advanced medical procedures for the prevention, diagnosis, treatment, and management of illnesses. Other examples include, but are not limited to, institutions which enable students to explore the health sciences while earning a degree in environmental engineering. Math is a crucial part of medicine since all the graphs, equations, statistics, and general mathematics learned help us to understand important aspects of human and veterinary medicine, biology, and science in general. Data Science helps in the recognition of scanned images to figure out the defects in a human body for helping doctors make an effective treatment strategy.
AND,
RELEVANT YEARS OF EXPERIENCE: Applicants must meet one of the following education and relevant years of experience combinations to qualify for this AD-0601, Band C (GS-13 equivalent) position:
A bachelor's degree and also have 4 years of relevant experience (1) analyzing complex clinical information and translating findings into science-based recommendations; (2) preparing written reports, correspondence, and guidance that clearly communicates complex scientific conclusions to internal and external stakeholders; and, (3) maintaining current scientific expertise through literature review, conferences, or similar professional development activities to ensure evidence-based regulatory recommendations.
OR,
A master's degree and also have 3 years of relevant experience (1) analyzing complex clinical information and translating findings into science-based recommendations; (2) preparing written reports, correspondence, and guidance that clearly communicates complex scientific conclusions to internal and external stakeholders; and, (3) maintaining current scientific expertise through literature review, conferences, or similar professional development activities to ensure evidence-based regulatory recommendations.
OR,
A doctorate, or J.D. degree and also have 1 year of relevant experience (1) analyzing complex clinical information and translating findings into science-based recommendations; (2) preparing written reports, correspondence, and guidance that clearly communicates complex scientific conclusions to internal and external stakeholders; and, (3) maintaining current scientific expertise through literature review, conferences, or similar professional development activities to ensure evidence-based regulatory recommendations.
OR,
A MD, DO, DDS, DPM, or DVM degree.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Qualifications:
In order to qualify for the Clinical Analyst position which falls under the 0601 occupational series, you must meet the following requirements by 11:59 pm EST on 06/12/2026:Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-medical-and-healthcare-series-0601/
General Medical and Healthcare Series, 0601, Individual Occupational Requirements
Basic Requirements:
Education: 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 at the time the degree was obtained.
Clarification from the agency regarding qualifying degrees for the General Medical and Healthcare, 0601 series: Professional work requires knowledge in a field of science or learning characteristically acquired through education or training equivalent to a bachelor's or higher degree with major study in or pertinent to the specialized field, as distinguished from general education. Work is professional when it requires the exercise of discretion, judgment, and personal responsibility for the application of an organized body of knowledge that is constantly studied to make new discoveries and interpretations, and to improve data, materials, and methods.
Medical Fields: Medicine, dentistry, podiatry, optometry, chiropractic, pharmacy and veterinary medicine. It also means applications or products for the diagnosis, treatment, mitigation or prevention of a physical or mental disease, disorder or abnormal state, or its symptoms, where such applications or products are approved by or subject to the approval of the U.S. Individuals in the medical fields are licensed professionals who have advanced or medical degrees. The term "medical" relates to or is concerned with physicians or the practice of medicine.
Health Sciences Fields: An interdisciplinary field that involves applying concepts from the natural and social sciences to health-related topics such as medicine, nutrition, environmental health, disease, and healthcare. Health sciences are those sciences which focus on health, or health care, as core parts of their subject matter. It deals with human and animal health. It also involves applying scientific research to clinical practice, in effort to improve healthcare for patients and communities. Health sciences relate to multiple academic disciplines, including, disciplines in the life sciences, physical sciences, engineering, mathematics, computer science, the health sciences, and emerging patient safety disciplines (such as social care research). Generally speaking, an undergraduate degree in health sciences prepares an individual for employment as a technician (e.g., cardiovascular technician, surgical technician, anesthesia technician, medical lab technician, veterinary technician, pharmacy technician, etc.), assistant (e.g., occupational therapy assistant, etc.), dental hygienist, paramedic, etc.
Allied Sciences Fields: Broad fields of health-care professions made up of specially trained individuals (such as physical therapists, dental hygienists, audiologists, and dietitians) who are typically licensed or certified but are not physicians, dentists, or nurses. Generally speaking, an undergraduate degree in Allied Health Sciences prepares an individual for immediate employment in a variety of health fields including case management/patient care coordination, health education, medical billing and account management, health marketing and sales, laboratory research, health insurance administration. Allied subjects are upper-division math, science, or engineering courses that have a background connection or relevance to chemistry.
Here are a few examples of how disciplines in engineering, mathematics, data science, etc. may be used in realm of health sciences. These examples are not all inclusive. For example, engineering professionals lead or participate in research and development of cutting-edge technologies for new drugs (including drug discovery, design, development, and delivery) and advanced medical procedures for the prevention, diagnosis, treatment, and management of illnesses. Other examples include, but are not limited to, institutions which enable students to explore the health sciences while earning a degree in environmental engineering. Math is a crucial part of medicine since all the graphs, equations, statistics, and general mathematics learned help us to understand important aspects of human and veterinary medicine, biology, and science in general. Data Science helps in the recognition of scanned images to figure out the defects in a human body for helping doctors make an effective treatment strategy.
AND,
RELEVANT YEARS OF EXPERIENCE: Applicants must meet one of the following education and relevant years of experience combinations to qualify for this AD-0601, Band C (GS-13 equivalent) position:
A bachelor's degree and also have 4 years of relevant experience (1) analyzing complex clinical information and translating findings into science-based recommendations; (2) preparing written reports, correspondence, and guidance that clearly communicates complex scientific conclusions to internal and external stakeholders; and, (3) maintaining current scientific expertise through literature review, conferences, or similar professional development activities to ensure evidence-based regulatory recommendations.
OR,
A master's degree and also have 3 years of relevant experience (1) analyzing complex clinical information and translating findings into science-based recommendations; (2) preparing written reports, correspondence, and guidance that clearly communicates complex scientific conclusions to internal and external stakeholders; and, (3) maintaining current scientific expertise through literature review, conferences, or similar professional development activities to ensure evidence-based regulatory recommendations.
OR,
A doctorate, or J.D. degree and also have 1 year of relevant experience (1) analyzing complex clinical information and translating findings into science-based recommendations; (2) preparing written reports, correspondence, and guidance that clearly communicates complex scientific conclusions to internal and external stakeholders; and, (3) maintaining current scientific expertise through literature review, conferences, or similar professional development activities to ensure evidence-based regulatory recommendations.
OR,
A MD, DO, DDS, DPM, or DVM degree.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Responsibilities:
- Determines whether clinical trials of new drugs in humans are soundly conceived and supported by prior animal testing, and other controls adequate to justify tests in humans.
- Evaluates submissions from applicants seeking permission to market new drugs for general use and makes recommendations on the adequacy of the efficacy and/or safety data provided.
- Conducts labeling review and determines whether proposed labeling contains truthful claims for safety and effectiveness; and adequate directions for use and warnings against misuse.
- Makes recommendations on the accuracy of clinically relevant product information in the labeling and compliance with content requirements and all labeling regulations.
- Reviews periodic and annual reports submitted by applicants on drugs approved for marketing.
- Provides recommendations on clinical and safety data tables.
- Incorporates the summaries of pharmacologists and chemists as part of the decision-making process in determining whether to approve an application.
Salary : $121,785