Pharmacokineticist

Conducts and/or reviews scientific processes, performs evaluations, exposure and/or other risk assessments. Identifies and assesses complex or precedent-setting issues that may have impact on procedures, policies, or required resources. Determines whether a scientific study or regulated facility conforms to applicable FDA laws and regulations. Analyzes the design and results of scientific experiments to determine whether data generated is accurate and valid. Applies appropriate precedence to the interpretation of chemistry-related data pertaining to HFP/CVM-regulated products to support decisions. Prepares and finalizes reports setting forth conclusions regarding chemistry-related studies. Considers scientific findings from multiple studies to provide comprehensive and consistent conclusions and recommendations.