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Supervisory Interdisciplinary Scientist

FDA

RemoteFull timeMid levelPosted today
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About the role

Duties
The incumbent serves as the Supervisory Interdisciplinary Scientist, (Branch Chief, Hematology Branch). If selected for this position, you will:

  • Serve as the technical authority and principal advisor to the Director, Division of Immunology and Hematology Devices (DIHD), and Deputy Director, DIHD, on scientific and medical review evaluation for documents and activities related to clinical immunology, hematology, flow cytometric neurology coagulation in-vitro diagnostic medical devices with regard to safety and effectiveness;
  • Develop and implement Division of Immunology and Hematology Devices (DIHD) policies and plans, and make critical decisions and provide expert advice and counsel concerning approaches and options that are sound and feasible in relation to Office and Center goals and objectives and Federal budgetary and economic realities;
  • Plan, manage, enforce, develop, and interpret premarket and postmarket laws, regulations, policies related to immunological, hematology, flow cytometric neurological coagulation in vitro diagnostic medical devices;
  • Supervise, direct, and coordinate the work of scientific, engineering, and technical employees engaged in the regulatory review of medical devices related to hematology;
  • Further the goals of Equal Employment Opportunity by taking positive steps to assure the accomplishment of affirmative action objectives and by adhering to nondiscriminatory employee practices with regard to race, color, religion, sex, national origin, age, or handicap.

Qualifications
In order to qualify for a Supervisory Interdisciplinary Scientist position, you must meet the following requirement:

BASIC QUALIFICATION
BIOLOGY, GS-0401
A. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.

  • OR-
    B. Combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.

MICROBIOLOGY, GS-0403
A. Degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.

  • OR-
    B. Combination of education and experience: courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.

TOXICOLOGY, GS-0415
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.

ADDITIONAL MINIMUM QUALIFICATION REQUIREMENT
GS-14:
You must have one (1) year of specialized experience which is equivalent to at least the GS-13 grade level in the Federal service to include providing technical guidance to researchers, evaluators, or other scientific staff on the review and evaluation of in-vitro medical devices and radiological products; and reviewing technical policies and programs to identify areas for improvement or resolve common problems.

In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

Education
If you are claiming education as any part of your qualifications for this position, 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 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.

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