• Agency policy lead on ClinicalTrials.gov matters, providing regulatory support to FDA staff tasked with enforcing the clinical trial registration and results information reporting requirements set forth in section 402(j) of the Public Health Service Act and its implementing regulations.• Advise OCLiP leadership on development of proposed and final rules relating to the protection of human subjects participating in FDA-regulated research.• Provide technical assistance on proposed legislation concerning ClinicalTrials.gov, good clinical practice, human subject protection, and other matters within FDA’s jurisdiction.

• Advised CDER leadership and staff on matters relating to investigational new drug applications, drug supply chain security, tobacco products, and compliance with the National Environmental Policy Act.• Wrote responses to citizen petitions pertaining to FDA’s regulation of human drug products, with a focus on petitions concerning the safety and effectiveness of generic drug products.• Reviewed and commented on rules, guidance documents, responses to congressional inquiries, and controlled correspondence drafted by other offices within CDER.• Represented CDER’s interests in an Agency-wide working group that developed a jurisdictional framework for products made or derived from tobacco.• Implemented programs and projects to identify, assess, and address issues in the areas of drug quality, safety, and supply chain security.

• Provided guidance and legal interpretation in matters involving the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Food Quality Protection Act, Occupational Safety and Health Act, and various other federal environmental, health, and safety laws. Counseled clients on the propriety of federal agency actions under the Administrative Procedure Act.• Litigated environmental cases involving the Clean Air Act, Endangered Species Act, and FIFRA. Assisted in developing litigation strategies and drafting pleadings, dispositive pretrial motions, and appellate briefs. Supervised the work of junior attorneys and litigation support staff, and negotiated discovery disputes and various other issues with opposing counsel.• Evaluated the potential impact on clients of proposed rules issued by the U.S. Environmental Protection Agency (EPA), Pipeline and Hazardous Materials Safety Administration, and other federal agencies. Worked with other attorneys and client personnel to plan and draft written comments on proposed rules.• Represented pesticide manufacturers and distributors in enforcement proceedings initiated by EPA and state regulatory bodies. Helped negotiate stipulated penalties in settlement of enforcement actions.• Advised a joint-venture of major electronics manufacturers on a variety of legal and policy issues related to the establishment and operation of electronic waste recycling programs. Drafted customer and supplier contracts and made recommendations on corporate governance matters to the client’s management team.• Worked extensively with scientific experts and consultants in the areas of economic analysis, public health, risk assessment, and occupational exposure.

• Researched and wrote memoranda in connection with a Freedom of Information Act (FOIA) lawsuit against the Department of Energy concerning the deliberations of the National Energy Policy Development Group.• Analyzed National Pollutant Discharge Elimination System (NPDES) compliance reports to determine if the facilities identified in the reports were susceptible to civil suits under the Clean Water Act.

• Advised the Executive Director on CRI’s involvement in a coalition of businesses and environmental groups tasked with analyzing the cost-effectiveness of beverage container recovery programs.• Assisted with drafting state beverage container recycling legislation.• Conducted research on the impact of beverage container deposits on overall litter composition and cleanup costs.• Analyzed the beverage container market to determine trends in container size, material, and recycling.• Maintained CRI's technology infrastructure and updated the content of CRI's website.• Handled requests for beverage container recycling information.