PDF versionJob Summary
This Direct-Hire position is in the Food and Drug Administration, located in Silver Spring, MD. If selected, you will be responsible for determining whether scientific evidence establishes the safety and activity of drugs and advising on issues related to nonclinical in vitro and animal studies.
Major Duties
- Evaluates biological activity of drug and toxicological potential on organ systems, tissues, and cells and animals, in general. Analyzes adverse effects of drugs on the processes of reproduction and on offspring.
- Collaborates with interdisciplinary teams in making regulatory decisions on biological aspects of safety and efficacy of human drugs during the review process.
- Writes comprehensive summaries and integrate discussions of data submitted for review and other available information.
- Represents the organization in meetings to advise and provide guidance on aspects of applications, notices, and/or reports on nonclinical studies to support clinical trials and approval as well as communicate deficiencies in animal studies.
- Attends professional meetings, conferences, and symposia of scientific organizations and presents to professional groups on biological, pharmacological and toxicological aspects of drug evaluation.
Qualifications
BASIC QUALIFICATIONS:
In order be eligible for the position of Biologist, (GS-0401-13), you must meet one of the following basic requirements AND the specialized experience. Basic Requirements Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. - OR - Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. You must provide a copy of your transcripts (unofficial) or foreign equivalency with your application. Failure to do so will result in you being rated ineligible for this position. MINIMUM QUALIFICATIONS REQUIREMENTS:
You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-12) in the Federal service. Such experience includes: Assisting in the review and evaluation of scientific submissions focusing on nonclinical in vitro and animal data and evaluation of drug safety in support of proposed clinical studies or product labeling; Writing reports of findings; AND Making recommendations regarding product labeling as it relates to in vitro and animal studies. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login,select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete. PLEASE BE CLEAR AND SPECIFIC IN DESCRIBING YOUR EXPERIENCE. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. All qualification requirements must be met by 11:59 pm (Eastern Time) on 03/06/2020. 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.
Pay Range
$102,663.00 - $133,465.00