Clinical Analyst

Summary This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C. Responsibilities Determines whether clinical trials of new drugs in humans are soundly conceived and supported by prior animal testing, and other controls adequate to justify tests in humans. Evaluates submissions from applicants seeking permission to market new drugs for general use and makes recommendations on the adequacy of the efficacy and/or safety data provided. Conducts labeling review and determines whether proposed labeling contains truthful claims for safety and effectiveness; and adequate direct...