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Toxicologist at FDA - JobAssist
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Home›Jobs›IT & Software›Toxicologist
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Toxicologist

FDA

RemoteFull timeMid levelPosted today
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About the role

Duties
As a Toxicologist you will perform the following duties:

  • 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.
  • Possess a mastery of the theories, principles and methods in the toxicology discipline and associated scientific disciplines. Studies and maintains familiarity with the pharmacological, biochemical, and toxicological scientific literature in order to keep abreast of current trends.
  • Provide recommendations for solutions on a variety of toxicology issues such as neuro-toxicology, reproductive toxicology and developmental toxicology.
  • Meets with industry or drug sponsor representatives to exchange information and to provide guidance regarding those aspects of the applications, notice, amendment, supplement or report which fall within area of review.
  • Attends meetings, conferences and symposia of organizations to remain aware of scientific developments, to exchange ideas with other scientists engaged in related work, and develop background data pertinent to the program.

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.

Job details

Workplace

Remote

Employment

Full time

Seniority

Mid level

Headquarters

Silver Spring, Maryland

Posted

Posted today

About company

Headquarters

Silver Spring, Maryland

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AND
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.

Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

Education
If you are claiming education as any part of your qualifications for this position, at this time you may submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.

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