Biologist

Employer
Department Of Health And Human Services
Location
Silver Spring, MD
Posted
Jul 20, 2021
Closes
Jul 23, 2021
Ref
2129088037
Function
Accountant, IT
Industry
Education
Hours
Full Time
Duties Help Duties Summary This Direct-Hire position is in the FDA located in the Center for Devices and Radiological Health. CDRH assures that patients and providers have continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical devices innovation by advancing regulatory science, providing industry with predictable, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the US Learn more about this agency ResponsibilitiesWorks closely with senior level reviewers in the review and evaluation of scientific data submitted to the FDA by medical device industry to determine safety and efficacy of routine and non-complex medical device products.Serves as consultant and advisor to scientific and technical personnel inside and outside the agency in a wide-ranging arena of scientific subject matters to include the field of medical devices and/or radiological product analysis and methods.Conducts and participates in discussions with industrial scientists and management officials regarding the development and regulation of medical devices.Writes and evaluates guidelines concerning the data required in submissions to the Agency for medical devices and their marketing.Develops, modifies, and evaluates guidelines concerning data required in device actions submitted to the Agency for medical devices. Travel Required 25% or less - You may be expected to travel for this position. Supervisory status No Promotion Potential 13Job family (Series) 0401 General Natural Resources Management And Biological SciencesRequirements Help Requirements Conditions of EmploymentCitizenship Requirement: You must be a US Citizen to be considered for this advertisement unless explicitly stated otherwise.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.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.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.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. Qualifications The position of Biologist falls under the 0401 occupational series. To qualify for this position at grade GS-13, you must meet the following: Basic Requirements 1. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. OR 2. Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND Minimum Qualifications Specialized Experience. Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. For the GS-13 level, you must possess one year of experience equivalent to at least the GS-12 level or equivalent pay band level of responsibility in the Federal service. This experience includes: Providing scientific guidance in the review of biological experimentation processes; Providing technical advice for complex, scientific tests, investigate environmental/ biological conditions and/or protocols to develop new techniques; and Analyzing scientific data to evaluate eco-biological/ biological conditions and preparing synopsis of data; and interpreting scientific directives to provide recommendations to other scientists. All qualification requirements must be met by 11:59 pm (Eastern Time) on 07/19/2021. 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. You must continue to meet all requirements through the hiring process. You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office. 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, 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. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. 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. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (eg, Peace Corps, AmeriCorps) and other organizations (eg, professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education EDUCATION: TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the Application Manager Documentation for tips on submitting your paper-based documents. FOREIGN EDUCATION Applicants using part or all of their education completed outside of the US to meet the qualification requirementsmust have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the US We will only accept the completed foreign credential evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the US education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:National Association of Credential Evaluation Services (NACES)Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the US Department of Education website for Foreign Education Evaluation#06022021

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