Food and Drug Administration Toxicologist in College Park, Maryland

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Duties
Summary

This position is located in the Department of Health and Human (DHHS), Food and Drug Administration (FDA), in one of the following locations: Greenbelt, MD, College Park, MD, Rockville, MD, and/or Silver Spring, MD.

This announcement will be used to fill various positions. Positions may or may not have promotion potential. Additional selections may be made within the same geographical area FDA-wide.

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Responsibilities
  • 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.
Travel Required

Not required

Supervisory status

No

Promotion Potential

13

  • #### Job family (Series)

0415 Toxicology

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  • Toxicologists

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Requirements
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 System OR have an approved exemption. VIsit www.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, GS-415-13, 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.**

Education

**You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Additionally, please submit all transcripts that may help you meet the basic education requirement. If you have more than one degree, upload each transcript separately**.

Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Additional information

ADDITIONAL CONDITIONS OF EMPLOYMENT:

  • If you are serving, or have served in the last 5 years ( from 09/25/2018 ) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. Pre-Employment Physical: No Drug Testing Requirement:No License Requirement:No Immunization Requirement: No Mobility Agreement Required: No Bargaining Unit Position: Yes (TBD) Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Veterans Preference for more. Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site. Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Individuals with Disabilities for more. Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Career Transition Assistance for more.

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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 09/25/2018), 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/10297284

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Background checks and security clearance
Security clearance

Public Trust - Background Investigation

Drug test required

No

  • Required Documents

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Required Documents

The following documents are REQUIRED for this vacancy: Resume Transcripts

"Required" indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the Applicant Help Site - Documents page for more information.

RESUME REQUIREMENTS: The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more detailed than the type of resume you may be familiar with from the private sector, especially if you're accustomed to submitting in CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this Resume Writing Tutorial video on the USAJOBS YouTube channel, or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.

The following documents are ACCEPTED for this vacancy: Cover Letter, DD-214, CTAP/ICTAP, VA Letter, Resume, SF-15, and Transcript "Accepted" means that you will have the opportunity to submit these documents, if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: "What types of documents might I need to provide?" or contact the FDA Applicant Help Desk.

ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:

  • Veterans: veteran eligibility documentation, including DD-214 Member #4 Copy, VA Letter, Standard Form (SF)-15, vary based on what preference you claim. If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011. Learn more about Veterans Preference and documentation requirements on the USAJOBS Help Site for Veterans.
  • Individuals with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for Individuals with Disabilities.
  • Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Please see the USAJOBS Help Site page for Career Transition for more information.
If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

  • Benefits

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Benefits

A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits.

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.

  • How to Apply

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How to Apply

To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 09/25/2018. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered.

If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.

The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!

You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.

If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Deskat 888-478-4340,or e-mail* QuickQuestions@fda.gov*. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10297284 so that we may assist you faster.

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Agency contact information
FDA Applicant Help Desk
Phone

888-478-4340

Email

quickquestions@fda.gov

Address

Office of Operations 10903 New Hampshire Ave Silver Spring, MD 20993 US

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Next steps

Once your application is received, you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement (09/25/2018). You will receive application status updates via email and via USAJOBS as the process unfolds. How to check your application status and understand what each status means.

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  • Fair & Transparent
Fair & Transparent

The Federal hiring process is setup to be fair and transparent. Please read the following guidance.

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

  • Equal Employment Opportunity (EEO) for federal employees & job applicants

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Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.

Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:

  • An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
  • An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
  • An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.

You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.

Learn more about disability employment and reasonable accommodations or how to contact an agency.

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Legal and regulatory guidance
  • Financial suitability
  • Social security number request
  • Privacy Act
  • Signature and false statements
  • Selective Service
  • New employee probationary period

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/510140200. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.

Open & closing dates: 09/12/2018 to 09/25/2018

Service: Competitive

Pay scale & grade: GS 13

Salary: $96,970 to $126,062 per year

Appointment type: Permanent

Work schedule: Full-Time