Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed Yes You may/may not qualify for reimbursement of relocation expenses in accordance with agency policy.
A bachelor's or higher degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology. 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/pharmacology-series-0405/
SPECIALIZED EXPERIENCE REQUIREMENTS:
One year of specialized experience equivalent to the GS-12 level in the Federal service, to include experience performing research and proposing solutions to support regulatory decisions actions; identify techniques or modify existing methods to improve the scientific quality and validity of pharmacological studies; and assess the safety of the drug based experiments.
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 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) - 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.
Listed below are desired experience for the following Centers:
CVM - Employs pharmacostatistical methods to evaluate data and perform reviews of bioavailability, bioequivalence, and pharmacokinetic studies to assure the scientific integrity and appropriateness of study designs; performs pharmacokinetics and Pharmacodynamics modeling and analysis utilizing software (such as WinNonLin, NONMEM, or WinBUGS).
CDER - Office of Translational Sciences/OSIS - Supervising, or reviewing work related to development, assessment, analysis of drugs, biologics; pharmacokinetic, pharmacodynamic, safety, efficacy studies done in animals (pre-clinical) or human beings (clinical trials). Validation and Analysis of drugs using various techniques including LCMS, HPLC or other methods. Knowledge of GLP, GCP, Bioequivalence, statistical analysis. Related travel is involved for certain CDER offices especially, OSIS and OSI. Proficient at oral and written communication.Office of New Drugs/Office of Generic Drugs - Reviewing, evaluating and interpreting pharmacology studies, data, applications, and/or reports; conducting research in pharmacology or 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.
CTP - (Division of Nonclinical Science) Assists in the conduct of research in pharmacology/toxicology studies that would have included adverse pharmacological effects endpoints; or instruction in pharmacological studies using computer modeling, to evaluate pharmacokinetics or adverse effects endpoints; or instruction in PBPK modeling of chemicals; or instruction in risk assessment of toxic chemicals or chemical mixtures.
CTP - (Division of Individual Health Science) Performs behavioral pharmacology assessments on drugs of abuse, chemicals found in or formed from the use of tobacco products, or tobacco products themselves..
You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
Evaluation of Education:
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 CONDITIONS OF EMPLOYMENT:If you are serving, or have served in the last 5 years (from09/25/2018 ) 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.
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 drug development, assessment, and its chemical effects in products.
2. Ability to analyze and evaluate short-and-long term effects of drugs and therapeutic chemical on living systems and related parts.
To preview the application assessment questions, click the link below: