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Who May Apply:
Federal employees with career or career-conditional appointments in the competitive service within the Office of New Drugs (OND).
This position is located in the Center for Drug Evaluation and Research, Office Division. SUBMIT YOUR SF-50.
PHS Commissioned Corps Officers that are interested in this position may appoy online.
There may be multiple positions filled in multiple locations.
Reviews and evaluates scientific submissions focusing on non-clinical in vitro and animal data and evaluation of toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in the labeling. This process includes evaluation of toxicological potential on all organ systems, tissues, and cells, and on the animal in general, as well as possible adverse-effects of drugs upon the processes of reproduction and on the offspring. Often the carcinogenic potential must be evaluated. The incumbent develops comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.
Prepares comprehensive summaries and integrated discussions of data submitted for review and other available information. Submits substantive regulatory recommedations and conclusions for concurrence by the scientific supervisor.
Meets with industry representative to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review, wth emphasis on non-clinical studies to support clinical studies or NDA or BLAs, as well as deficiencies in animal studies.
Provides leadership, guidance and/or regulatory expertise to address and solve complex regulatory issues consistent with technological developments or new scientific evidence, and provides innovative solutions to complex problems.
Attends meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field, to exchange ideas with other scientific peers engaged in related areas, and to acquire background information pertinent to the conduct of Divisional responsibilities.