• Conducts research and evaluates premarket and postmarket data that supports product safety, efficacy, performance, and quality.
• Reviews and evaluate the results of nonclinical pharmacological and toxicological studies submitted in support product applications.
• Interpret and evaluates the results of studies to determine the validity and scientific significance and to ensure all the necessary information was obtained.
• 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.
• Provides recommendations for solutions on a variety of toxicity issues such as neuro- toxicity, reproductive toxicity and developmental toxicity, carcinogenicity, cardiotoxicity, etc.
• Conducts safety assessments on drug products, requiring review, interpretation, and integration of toxicology information for communicating a regulatory recommendation to multiple review disciplines.
• Provides written and oral communication regarding toxicology issues in pre- and post-marketing review activities.
• Reviews and evaluates toxicological studies; environmental toxicity, and information to ensure the safety of human drugs, animal drugs, food for animals, food products made from animals to humans and to the environment
• Analyzes biochemical, toxicological, physiological, or related data to conduct risk assessments.
• Provides guidance and recommendations to solve complex toxicology issues related to human drugs,animal drugs, foods, and devices.

Conditions of employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.

Qualifications

In order to qualify for Toxicologist, 0415, at GS - 13, you must meet the following:

To qualify for the Toxicologist, GS-13 position you must meet BOTH the basic requirements and specialized experience requirements:

BASIC REQUIREMENTS:
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. Click on the link below to identify qualifying coursework. Note: When applying for this position, you must submit an unofficial transcript demonstrating your degree and appropriate coursework and semesters hours. If selected, an official transcript will be required upon appointment.

Qualifying Coursework:https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/toxicology-series-0415/

SPECIALIZED EXPERIENCE REQUIREMENTS:
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 toxicology 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.

Positions are located in throughout the following FDA Centers:

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

Center for Devices and Radiological Health (CDRH) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways for devices marketed in the U.S. Toxicologists at CDRH engage in investigative research, toxicological risk assessments, and/or regulatory review.

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. Performing specific toxicology research, analytical, and advisory scientific work as it relates to food safety, labeling, infant formula, dietary supplements, and/or cosmetics. Engages in research of adverse effects of chemical substances or similar agents on living organisms and/or the environment, and the assessment of the probability of adverse effects under specified conditions of product use or chemical exposure.

Center for Tobacco Products (CTP) - Establish tobacco product standards, review premarket applications for new and modified risk tobacco products using available information identify gaps in scientific knowledge, define scientific questions critical to science-based tobacco product regulation, guide research performed by collaborators and contractors, provide scientific knowledge to implement statutory provisions, and provide scientific support for tobacco regulatory science needs in regulations, guidance, and policies for public health impact. Effectively communicate scientific recommendations and applied regulatory research outcomes to appropriate audiences.

Center for Veterinary Medicine (CVM) - CVM has regulatory authority over food, food additives, drugs, and devices for animals. These animals include those from which human foods are derived, as well as pet (or companion) animals. The Center is responsible for regulating the food, food additives, drugs, and devices given to over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species. As a high-performance organization, CVM strives for leadership, innovation, and excellence across all operations, occupations, and grade levels. As a Toxicologist at the Center, you will apply knowledge of toxicological science, methodology, risk analysis, and applicable regulations to inform scientific and regulatory decisions regarding the safety of animal drugs, foods, and devices.

Desired experience for the following FDA Centers:

CDER - reviewing, evaluating and interpreting toxicological studies, data, applications, and/or reports; conducting research in toxicology or the development of assessments that address nonclinical safety data from the pre and post marketing periods and generating written and verbal summaries of such information for use by others.

CDRH - Conduct research to develop predictive toxicology and risk assessment approaches focused on in vitro and in vivo toxicology, biocompatibility testing, and computational methodologies, and possess and maintain the critical knowledge needed to regulate the safety and efficacy of medical devices and medical device materials, extracts, and leachables. Review and interpret toxicology data from product applications. Provide independent evaluations of the adequacy to the toxicological risk assessments in regulatory submissions.

CTP - Conducts laboratory or non-laboratory studies that evaluate toxicological endpoints, or performing analysis of the same studies performed by others to reach a conclusion of the totality of data; or conducts risk assessments of chemicals or chemical mixtures; or reviews and evaluates the toxicological information for chemicals or complex chemical mixtures; or conducts toxicity evaluations or risk assessments of chemicals or chemical mixtures; or identifies data gaps in the toxicological information related to regulated products (e.g., drugs, food additives, chemicals).

CVM - Analyzing biochemical, toxicological, and physiological data as well as conducting risk assessments to evaluate the safety of products on humans, animals and/or ecosystems; analyzing and evaluating protocols and/or procedures to determine whether toxicological or related data generated is accurate and valid; and, evaluate experiments/studies for conformity with current Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) requirements, and/or other applicable regulations.

CFSAN - Performs specialized investigative research, analytical and advisory scientific work as it relates to food labeling, infant formula, dietary supplements, and/or cosmetics and conduct risk assessments related to these areas.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 07/09/2018), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.

1. Knowledge of principles, practices and techniques relating to toxicology.
2. Ability to analyze and interpret toxicological studies.
3. Communication

To preview the application assessment questions, click the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/10238248