As principal advisor to and spokesperson for the Associate Commissioner for Regulatory Affairs (ACRA), the Director develops and directs criminal investigation activities in coordination with other Agency components and other Federal, State, and local law enforcement agencies. Assures coordination of criminal investigation activities with FDA's nationwide field organizations and adherence to the Agency's enforcement priorities.
Provides authoritative assistance, interpretations, and recommendations to Senior Agency officials, scientific and professional personnel, departmental representatives, intra-governmental counterparts and others concerning FDA criminal investigation activities. Provides recommendations to DHHS' Office of General Counsel on referrals or criminal cases to the Department of Justice for further investigation and/or prosecution or directly to the U.S. Attorney, when such direct references are appropriate.
Appraises the organizational structuring of functional responsibilities and work assignments to assure the effective and efficient use of investigative personnel. Identifies staffing needs and assists in attracting and retaining high quality managerial personnel for key positions.
Provides executive leadership and technical direction to Field Offices located throughout the United States, including approximately 270 professional and technical support engaged in:
-Evaluation of criminal investigation findings and determining appropriate follow-up. Provides recommendations on referrals of criminal cases to the Department of Justice or the responsible U.S. Attorney for litigation and assisting in implementing approved actions.
-Coordinating and implementing FDA policy related to criminal investigations, providing investigational support to headquarters components and across Area Office's boundaries as needed, providing counsel and training regarding criminal investigative techniques, equipment, safety, and security to Agency personnel.
-Participation in Grand Jury investigations and serves as agent of the Grand Jury.
-Advising headquarters on new and emerging problems and trends, program needs and priorities, manpower, equipment, financial needs, and the Agency's long range planning in the criminal investigative areas.