We are seeking an experienced Clinical Reviewer Scientist to support the FDA Office of Computational Sciences. This role provides subject matter expertise across multiple clinical projects and plays a key role in ensuring the safety, integrity, and regulatory compliance of drug applications submitted for regulatory review. Responsibilities Serve as a subject matter expert for clinical safety studies submitted to the FDA in support of drug applications. Review clinical and nonclinical data to ensure regulatory compliance, human subject safety, and data integrity, and communicate findings to a multidisciplinary review team. Evaluate nonclinical sections of product labeling and provide regulatory recommendations. Lead and complete special projects focused on: Design, characterization, performance, and bioequivalence of complex drug products Development of advanced manufacturing approaches for drug substances and products Establishment of science-based drug quality standards Development of analytical and in vitro methods to support quality surveillance and investigate product quality failures Serve as a CDER resource by participating in internal work groups and subcommittees. Publish scientific articles in the area of expertise and maintain awareness of emerging scientific developments, integrating advanced research theories and practices into regulatory programs. Qualifications MD or PhD in a relevant scientific discipline required. Minimum of 5 years of experience as a reviewer scientist working on drug applications of various types. Strong understanding of regulatory compliance requirements and FDA review processes. Demonstrated ability to contribute to multidisciplinary teams and regulatory decision-making. Proven experience publishing scientific research in peer-reviewed journals. Seniority level Mid-Senior level Employment type Full-time Job function Science Industries Hospitals and Health Care Pharmaceutical Manufacturing Biotechnology Research Benefits Medical insurance Vision insurance Washington, DC $100,720.00-$188,850.00 #J-18808-Ljbffr Medasource
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