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  1. Jobs at the Center for Drug Evaluation and Research

Toxicologist Jobs in CDER

Toxicologist

Description of Duties:

 
GS-415-11/12:
  • Provides limited support to senior specialist input into developing and coordinating the Center's position in response to requests for guidance and interpretation of the Act, and work alongside senior specialist in the development of Compliance Policy Guides (CPGs), Regulatory Procedure Manuals (RPMs), and compliance programs for FDA District Offices.
  • Reviews and evaluates evidence and technical data for legal and administrative actions, recommendations, recalls and premarket approval clearance for Medical Devices, Safe Medical device, and Radiation Control for Health and Safety devices.
  • Prepare documentation for Agency/Center approval or disapproval of the appropriate action.
  • Provides headquarters' support for case development, technical review and assists with coordinating activities related to legal and administrative actions.
  • Initiates investigations to develop evidence to support appropriate administrative and regulatory actions.  The incumbent provides technical guidance as requested by agency and center officials.
 
GS-415-13:
  • Keeps abreast of current advances in diagnostic and medical equipment and quality control practices, as well as changes in the medical device regulations through careful scrutiny of scientific, legislative, and regulatory literature, personal contact with authorities in the centers and subordinate offices responsible to attend at appropriate scientific meetings.
  • Reviews and evaluates evidence and technical data for legal and administrative actions, recommendations, recalls and premarket approval clearance for Medical Devices, Safe Medical device, and Radiation Control for Health and Safety devices.
  • Provides headquarters' support for case development, technical review and coordinates activities related to legal and administrative actions.
  • Initiates investigations to develop evidence to support appropriate administrative and regulatory actions. 
  • Provides significant input into developing and coordinating the Center's position in response to requests for guidance and interpretation of the Act, and participates in the development of Compliance Policy Guide (CPGs), Regulatory Procedures Manuals (RPMs), and compliance programs for FDA District Offices.
  • Carries out the programmatic operations and responsibilities of the position in support of the enforcement of the Medical Device Amendments of 1976 including the Safe Medical Devices Act of 1990 and 1992 and the Radiation Control for Health and Safety Act of 1972 regarding safety, quality and manufacturing violations as they apply to domestic device manufacturers.
 
Qualifications:
In order to qualify for Toxicologist, GS-0415-13, you must meet the following:
 
A Degree: toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology. Courses in anatomy, chemistry, organic chemistry, biochemistry, biology, histology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry, biochemistry, and physiology. Courses in statistics, bioassay, and test design may also apply to this requirement. Courses in cytology, embryology, cellular or microbial genetics, and biophysics may also be used to meet this requirement in those instances where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved. Only toxicology courses may be used to meet the requirement for 12 semester hours in toxicology. This may include courses dealing intensively with toxicological search, methods in toxicology, essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects. You must submit transcript demonstrating degree and/or coursework as noted in the description above.
 
AND
 
GS-415-11: One year of specialized experience, equivalent to the GS-09 in the Federal service, to include reviewing and interpreting toxicological studies, data, applications, and/or reports; conducting research into the basis of toxicological and the development of assessments that address clinical and safety data from the pre and post marketing periods.
 
GS-415-12: One year of specialized experience, equivalent to the GS-11 in the Federal service, , to include reviewing and interpreting toxicological studies, data, applications, and/or reports; conducting research into the basis of toxicological and the development of assessments that address clinical and safety data from the pre and post marketing periods and assisting with written and verbal summaries of such information for use by others.
 
GS-415-13: One year of specialized experience, equivalent to the GS-12 in the Federal service, to include reviewing, evaluating and interpreting toxicological studies, data, applications, and/or reports; conducting research into the basis of toxicological and the development of assessments that address clinical and safety data from the pre and post marketing periods and generating written and verbal summaries of such information for use by others.
 
Grade (Salary) Level:
Federal General Schedule (GS) grade levels at which toxicologist positions are commonly filled are:
  • GS-11/12/13 at the headquarters and field levels
 
Geographical Locations:
Toxicologists are located at HQ (suburban Washington, D.C.) and in facilities throughout the U.S.

 

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