Donal Parks

Experience

• 

  U.S. House of Representatives

  Sept 2001 - Dec 2007

  Business Process Specialist

  I worked for the Chief Administrative Officer of the House - the person responsible for paying House staff, moving Members from one office to the next, maintaining the IT infrastructure of the House - you name it. If it wasn't security, protocol or legislative support, we did it. I started off in the Office of Finance as a management analyst and then took on the role of a business process specialist, eventually heading a team of seven staff working to update and streamline business processes while a new financial and personnel system was implemented. Show less

• 

  Policy Studies, Inc.

  Jan 2007 - Jun 2008

  Business Process Specialist

  Responsible for mapping all business processes for a State client providing child support services with an eye toward identifying improvement opportunities. Interview staff, research Federal, State and corporate guidance, and investigate options for improving the profit margin of the operation in Baltimore. Procedures developed in Baltimore were applied nationwide to other full-service child support contracts.

• 

  US Food and Drug Administration

  Jul 2008 - now

  I am currently the Deputy Director for Operations with the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). In this role, I am responsible for the support and improvement of the business processes underlying OSE’s drug safety regulatory review operations. This includes oversight of OSE’s regulatory project management function; regulatory-related and scientific information technology needs; processes for the development, review, and clearance of regulatory documents; training and development needs for OSE staff; oversight and development of the extramural budget and resource allocations related to OSE’s regulatory functions; leading strategic initiatives related to regulatory operations, including user fee negotiations with regulated industry, performance metrics and executive reporting; and strategic initiatives related to OSE, CDER, and FDA priorities. Show less Responsible for ensuring that user fee obligations incurred under the Prescription Drug User Fee Amendments (PDUFA), the Generic Drug User Fee Amendments (GDUFA), and the Biosimilar User Fee Act (BsUFA) are properly met by companies submitting marketing applications for innovator drug products, generic drug products, and biosimilar drug products, respectively. Together, these user fee programs generate approximately $1.2 billion annually to augment budget authority resources provided by Congress for the Agency to execute its public health mission. I also oversee the compilation of the annual budget request to Congress for CDER, and work with other parts of the Agency to implement new programs such as the Drug Quality and Security Act, which covers pharmacy compounding and track-and-trace programs. Show less

  • Deputy Director for Operations

    Feb 2020 - now

  • Director, Division of User Fee Management and Budget Formulation, Office of Management, CDER

    Jul 2008 - Feb 2020