This position is located in the immediate office of the Office of Policy and Risk Management, Office of Regulatory Affairs, Office of Global Regulatory Operations and Policy. The Testimony Specialist is a key member of the Offices management team and assists the Senior Testimony Specialist, the Office Director and other management officials in carrying out the diverse responsibilities related to the mission of the Office. Major duties include:
· Serves as an FDA/ORA expert in policy and procedures for handling testimonial requests, Department of Justice (DOJ) litigation holds, processing legal demands, subpoenas, and court orders imposed on the Agency arising from various legislative acts (e.g. Federal Tort Claims Act), Memoranda of Understanding (MOU), and private and public litigation matters within the purview of the Agency.
· Works with the Senior Testimony Specialist on the management and coordination of requests from agency components for authorization by the Director, Office of Policy and Risk Management, or his/her designee, to disclose information to federal and state government agencies.
· Performs extensive and thorough research on and review of legal demands, subpoenas, and court orders from persons outside of the Agency including private attorneys, law firms, federal and state government officials, state legislative committees, foreign governments and judicial representatives for the purpose of evaluating the merits and authorizing the expenditure of agency resources in complying with the orders.
· Researches relevant regulations and precedents and determines if documents or portions of them exist to provide the testimony sought in lieu of personal testimony.
· Identifies specific types of records maintained which would be relevant to providing the testimony request.
· Contacts the Office of Chief Council (OCC) to request their assistance in filing either a motion to quash a subpoena or request their presence at a deposition to protect the interest of the Agency in the event a deposition or personal testimony is authorized.
· Interviews potential witnesses for information to assist in the preparation of the official authorization for personal or deposition testimony.
· Provides expert information and consultation to individuals, other federal agencies, private industry, OCC, and foreign governments on the witness capabilities and responsibilities of FDA employees.
· Responsible for the preparation and submittal of the annual report on Agency testimony requests received and processed to the Office of the Commissioner and General Counsel.
· Responds to telephone inquiries from federal, state and private attorneys seeking information on the procedures for obtaining FDA testimony for both criminal and civil legal cases. Advises attorneys on the proper procedures and suggests means for how the testimony request may be handled other than by request for FDA witnesses, i.e., FOI, certification of records, etc.
· Serves as a technical expert and authority on policy and procedures for the development and clearance of Memoranda of Understanding (MOU) between FDA and other parties, including but not limited to federal, State and international regulatory counterparts.