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U.S. Department of Health and Human Services

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Regulatory Informatics Management Supervisor (Director of Information Systems Management)


Description of Duties
  • Leads the development of information management planning and policies in support of the ORA’s goals and objectives. This includes the development and approval of information management related guidance and specifications to ensure ORA document management systems (paper and electronic) accommodate the new, or amended, policies and procedures as defined, or required by, the need for new regulations, policies and programs, as well as the Federal e-Gov Program.
  • Provides coordinated, comprehensive plans to the agency for the entire field service and represents ORA regulatory business interests as the recognized ORA expert for information technology business processes as applied to FDA activities.
  • Ensures that information management planning and budget initiatives support ORA’s goals and objectives as outlined in the FDA Strategic IT plan, as well as other relevant  government and Agency Information Technology plans.  Plans, directs and assesses ORA-wide efforts to implement the goals and objectives of the IT strategic plan with a specific purpose of ensuring the effective implementation and resulting benefits for ORA.  Ensure the effective management, implementation, adoption and effectiveness of information management and process improvement projects and programs throughout ORA.
  • Ensures information management projects support and align with ORA and Agency business processes.  Develops the ORA’s information management budget to reflect strategic plans, and ORA, Agency and Federal Government-Wide initiatives and priorities.  Facilitates the efforts of the business unit and information technology organization to translate business needs into information technology requirements.  Works with ORA’s Office of Resource Management and FDA’s Office of Information Management (OIM) on budget development and execution.  Ensures that information process planning and resource initiatives support ORA’s mission and goals.
  • Reviews and evaluates the operating policies and procedures within the area of responsibility in order to develop and implement new policies. Ensures resolution of information technology business process and policy issues in cooperation with ORA Offices and leadership. Assures uniformity in these areas and modifies these operating policies and procedures in order to obtain the most efficient operation. Continually evaluates and when needed initiates action to improve coordination with the Offices including the respective IT budgets.
  • Works with the ORA Senior management Team, the ORA IT Advisory Council, Information Management Steering Committee (IMSC) and the Office of the CIO on the development and implementation of information management program and policies.  Collaborates with FDA’s Office of Information Management as an expert in the field of information management and ORA business processes. 
  • Represents ORA on Agency business process planning (BPP) and high level enterprise architecture (EA) initiatives.  Represents ORA on joint initiatives/partnerships with the regulated industry to improve performance through the use of information technology and related process improvement activities.
  • In coordination with the Office of the CIO, ensures that ORA has an effective information security posture and maintains security guidelines and procedures.
  • Provides expertise in the areas of business process management and improvement, and the application of information management to effect process improvement and cost reductions. Must be cognizant of all major ORA programs, policies and issues in order to ensure they are properly supported by Information Technology where necessary.
  • Develops or oversees Department, Agency and ORA training initiatives within the area of expertise.
Basic requirements for all grades in this position include:
A. 4 academic years above high school leading to a bachelor’s degree, or Bachelor’s degree, -OR-
One year of specialized experience, equivalent to the next lower grade level in the Federal service applying established methods and techniques to evaluate the efficiency or effectiveness of programs, work operations, or procedures; identifying trends or deficiencies with administrative or program operations and procedures; utilizing established databases to track time-sensitive documents; and reviewing scientific or technical documents for accuracy and completeness.  -OR- B. A Master's or equivalent graduate degree; or 2 years of progressively higher level graduate education leading to such a degree in public administration, business administration, or a closely related field which provided the knowledge, skills, and abilities to do the work of this position.  -OR- C. A combination of specialized experience as described in A and graduate education as described in B that, when combined, equal 100% of the total requirement. (Please note that only graduate education in excess of the first 18 semester hours may be used in this calculation.)
Grade (Salary) Level
This is a GS-15 opening at ORA Headquarters.
Geographical Locations
This position is located at ORA HQ (Rockville, MD).