FDA Employment – Lead Consumer Safety Officer

Job Responsibilities:

• Performs a variety of complex, substantive activities related to major OCQC programs and activities (e.g., critical regulatory areas, difficult, complex, controversial, and precedent setting regulatory policy evaluations, stakeholder communications, etc.). Serves as principal scientific advisor to their assigned Branch Chief, and performs substantive work with a multiplicity of unprecedented and complex scientific topics, including, but not limited to: compounded human drugs, the regulatory framework of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, evaluation of bulk drug substances used in compounding, developing new regulations and scientific policies, the Compounding Quality Center of Excellence, and stakeholder outreach. As principal advisor, the incumbent provides expert authoritative advice, guidance and recommendations on human drug compounding compliance policies, programs, processes, and proceedings.
• Leads the evaluation and identification, and then addresses significant problems and issues, in areas where nominal policy guidance exists, and requires prompt remediation. Exercises subject matter expertise/knowledge/experience in resolving problems, modifying procedures, and developing and implementing guidance, some of which form the basis for formal regulatory decision-making and direction. Formulates, develops, and presents expert findings and recommendations internally and externally, to OND USP, regulatory reviews and clinical divisions. Provides expert authoritative advice, recommendations, guidance, and assistance in addressing unusually difficult and/or complex problems.
• Serves as a recognized authority in scientific matters related to compounded human drugs and leads a team of subject matter experts that develops regulations and legislative proposals as well as guidance and policy documents necessary to implement the compounding provisions of the Drug Quality and Security Act. Monitors and reports on the status and progress of work, checks on work in progress and reviews work accomplished by team members to ensure that the instructions on work priorities, methods, deadlines, and quality have been met. The incumbent adjusts to accomplish the workload in accordance with established priorities to ensure timely completion of assigned team tasks and ensures that each employee has an integral role in developing the final team product.

Job Requirements:

• Expert skill in providing guidance and consultation to enforce regulatory objectives.
• Expert ability communicating scientific/technical information to others regarding regulatory compliance issues.
• Expert skill in interpreting legal or regulatory guidelines and agency policies to advise on program operations.
• Demonstrated experience applying the Food, Drug and Cosmetic Act (FDCA) to drug compliance/enforcement activities, and related compliance and enforcement activities.