Job Opportunity: Toxicologist, FDA Center for Tobacco Products, Silver Spring, MD

Kate Stuart
December 2, 2016

****This is an FDA-wide announcement, so ensure that you select CTP as your Center of interest when you apply. Don't forget to upload transcripts, including undergraduate.

 

Summary

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

Positions are located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) in Montgomery County, MD, and may be filled in the following Centers:

Center for Biologics & Evaluation Research (CBER) - Regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.

Center for Drug Evaluation & Research (CDER) Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new drugs.

Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways in devices marketed in the U.S.

Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.

Center for Tobacco Products (CTP) - Responsible for implementing the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products and manufactures based on the best available science and for both assessing and fostering that science base.

Office of Regulatory Affairs (ORA) –Inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States.

National Center for Toxicological Research (NCTR) - Provides the field offices with coordinated direction, assistance, and management for investigational activities in international arenas.

Center for Veterinary Medicine (CVM) - Conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals; and monitors the safety and effectiveness of animal drugs on the market.

 

Who May Apply: Open to all United States Citizens.

 

Duties

As a Toxicologist you will perform the following duties:

Provides limited support to senior specialist input into developing and coordinating the Center's position in response to requests for guidance and interpretation of Compliance Policy Guides (CPGs), Regulatory Procedure Manuals (RPMs), and compliance programs for FDA District Offices.

Assists in the determination and need for and requests establishment inspections as part of the approval process and to insure the safety of regulated products.

Reviews and evaluates manufacturers' and sponsors' data and results, method of synthesis and proposed manufacturing and testing procedures.

Prepares a summary of the data reviewed and submits recommendations and conclusions to the scientific supervisor.

Requests additional data or tests from sponsors and applicants and proposes changes when it is determined they are needed to make the necessary toxicological evaluations.

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.

Reviews and evaluates the results of nonclinical pharmacological and toxicological studies submitted in support of products regulated by FDA.

Prepares a comprehensive summary of the data reviewed and submits substantive

recommendations and conclusions for approval by the Supervisor.

Travel Required: Not Required

Relocation Authorized: No

 

Key Requirements

U.S. Citizenship is required.

Only experience gained by closing date announcement will be considered.

One year probationary period may be required.

 

BASIC QUALIFICATIONS

In order to qualify for Toxicologist, GS-0415-11, you must 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

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.

OR

Have 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree.

APPLY: https://www.usajobs.gov/GetJob/ViewDetails/458192100/