Regulatory Scientific Reviewer
Department of Health and Human Services
Duties
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Complete preliminary clinical reviews, assignments and projects related to regulated products that have a national or international impact on health.
Review the safeguards for testing experimental and/or use of approved products in humans.
Review primary functions and activities concerned with labeling, advertising, post-market monitoring, adverse reaction evaluation, improvement of research and evaluation practices.
Maintain cutting edge expertise of the "state of science" to incorporate the most advance theories and practices in clinical medicine, into the Division's and Branch's pre-market review activities.
Evaluate plans and protocols to conduct tests and clinical trials of Investigation New Drugs (INDs) in humans, submitted to the Agency, and application amendments.
Evaluate clinical trial reports in humans for evidence of safety, immunogenicity, and effectiveness of new preventive vaccines and biotherapeutic products submitted in support of new Biologic License Applications (BLAs).
Provide advice and guidance regarding those aspects of the application which fall within the incumbent's area of review expertise.
Department of Health and Human ServicesVacancy posted 20 hours ago
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