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Volunteer Spotlight

Volunteer Spotlight
Each month, RAPS turns the spotlight on a member making an impact in RAPS and on the regulatory community. These members are the backbone of the Regulatory Affairs Professionals Society and an inspiration for others. If you are interested in being highlighted or nominating another member for the spotlight, please contact Austen Gage at agage@raps.org.

Regulatory Job Openings

  • Ocala, Florida, What makes Kindred Healthcare a great place to work? Our people, of course! Our clinicians answer this special calling because they have a fundamental, internal drive to directly help people. In return, we serve, develop and respect our employees in environments created to optimize their job effectiveness, experience, and satisfaction. This is who we are. Who are you? To succeed in our high-energy, high-reward environment, our clinicians provide compassionate critical care and deliver exceptional patient experiences , meaningful outcomes, and bonds for life. As our most acute level of care, Kindred's transitional care hospitals offer the same critical care patients receive in a traditional hospital or intensive care unit , but for an extended recovery period. Our clinicians play a vital role in the recovery process for chronic, critically ill and medically complex patients . As a Director Quality Management you will: Responsible for planning and implementing the performance improvement program to meet the needs of the hospital. Provides education to medical staff, hospital staff, and Governing Body. Facilitates performance improvement activities, and CQI activities throughout the hospital. Acts as resource person to administrative team, department managers, and medical staff. Performs clinical risk management functions. Assists department managers with preparation for medical staff committees. Oversight responsibility for all regulatory body surveys, such as, JCAHO, State Licensing Review, HCFA (CMS) Validation surveys. Maintains oversight responsibility for all performance improvement activities conducted throughout the hospital. As a Director Quality Management you will have: Bachelor's degree. Certified Professional Healthcare Quality / CPHQ certification preferred. Minimum three (3) years' experience in Quality and/or Risk Management in a hospital setting. Job : Compliance/Quality/Risk Primary Location : FL-Ocala-Kindred Hospital - Ocala Organization : 4508 - Kindred Hospital - Ocala Shift : Day
  • Irving, Texas, Description Summary: The Director of Quality Improvement is responsible for daily operations associated with the Quality Improvement Department and is accountable for establishing and implementing an effective quality improvement program essential to meet state, federal and accreditation requirements. The Director is responsible for providing leadership to achieve the above goals as well as best practice performance levels in quality improvement. This role requires that the individual interfaces with a diverse range of clinical and administrative professionals, resolves complex policy and service issues and directs oversight of reporting activities required by regulatory agencies. This position is responsible for identifying and recommending initiatives as a result of evaluation of the health plan's activities and member population need. They include development and monitoring of quality indicators for plan performance, support of the Quality Improvement Committee, and promotion of continuous quality improvement activities within the entire organization. Responsible for all aspects of the Quality Improvement program for CHRISTUS Health Plan, including such activities as Budgetary responsibility for areas of related to the Quality Improvement Department Identifies need for and leads staff in development and revision of policies and procedures governing Quality Improvement Operations Provides supervision and support to the RN Manager and assures oversight of provider audits, education, associate training and review, work plan development, corrective action oversight, member safety and potential quality of care issue identification and investigation Oversees physician education efforts regarding HEDIS and any other needed education for success. Assures that all education is provided on an ongoing basis and includes the most up to date requirements and/or guidelines, as well as coordination with the Network Management field representatives Responsible for NCQA and URAC or other regulatory agency readiness, accreditation and coordination with accreditation agency. Leads efforts to prepare for audits, which includes departmental education, training/meetings and quality communication Quality Improvement Committee (QIC) participation, which may include being the committee Chair. Assurance that all required business areas are reporting in accordance to the QIC Work Plan. Oversight of HEDIS Improvement initiatives in conjunction with quality HEDIS subject matter expert, data analyst and IT support. Oversight of the HEDIS vendor, audit process, reporting of results to QIC and Board of Directors, comparing results to bench-marking data available, development of improvement activities and implementation of actions to improve. Assures that the annual Clinical Quality Management Program (CQMP) evaluation is complete timely as well as the Quality Program Description and Work Plan Oversight of the Peer Review Process (PRC), communication with external providers as well as Medical Director including coordination of meeting time, oversight of RN PQI investigation and staffing with MD, provider communication and upkeep of log and letter templates. Quarterly reporting to QIC for all PQI's for all LOB's Maintains Quality Improvement Activities (QIA's) and Performance Improvement Plan's (PIP's) Ensures that department priorities are aligned with Senior Leadership by meeting regularly with Business Unit leaders through the free and open exchange of information. Oversees quality contribution to member and physician education to include research and development and review of written material. Participates in appointed committees and sub-committee's as well as update inter-departmental structures as well as committee structure as needed Follow the CHRISTUS guidelines related to the Health Insurance Portability and Accountability Act (HIPAA), designed to prevent or detect unauthorized disclosure of Protected Health Information (PHI). Requirements: Bachelor Degree. Master's degree in Health Care Management preferred Excellent knowledge of accrediting standards relating to managed care operations/health plans Solid background in facilitation skills, process analysis tools and quality theories Strong interpersonal skills, including the ability to interact effectively with staff, employees, supervisors, managers, physicians, and hospital executives Effective verbal and written communications, and organizational skills Knowledge of computer systems and QI applications Ability to work collaboratively and effectively in intense environment Excellent speaking ability, judgment, initiative and problem solving abilities Considerable discretionary decision making Ability to handle and resolve complex issues Ability to work a flexible work schedule Meeting deadlines in high pressure environment High degree of personal accountability and integrity demonstrated Occasional Regional travel as necessary to achieve job responsibilities and strategic objectives. Long term project management skills Analytic ability to prepare status reports and document procedures Minimum five years quality management experience in the Health Care field Minimum five years of experience in Quality Improvement within a health plan Minimum five years of experience in leading effective HEDIS programs and accreditation Minimum five years of managed care experience Minimum of 4+ years of management experience Knowledge and experience regarding HEDIS, NCQA, URAC, QIC facilitation, Peer Review Committee oversight and regulatory Work Type:  Full Time
  • Bethesda, Maryland, Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases National Institutes of Health U.S. Division of Health and Hunan Services   The National Institute of Allergy and Infectious Diseases (NIAID)—one of the largest institutes of the National Institutes of Health (NIH)—is seeking exceptional and motivated candidates to join the Office of Regulatory Affairs in the Division of Allergy, Immunology, and Transplantation (DAIT). DAIT supports basic and clinical research to improve our understanding of fundamental immunology and the causes of diseases (such as food allergy, atopic dermatitis, asthma, and chronic rhinosinusitis) to ultimately develop better diagnostic, treatment, and prevention strategies.   The incumbent will maintain regulatory and quality assurance surveillance over all clinical trials and protocols supported by DAIT to ensure that trials are conducted in accordance with Food and Drug Administration (FDA) regulations; establish and monitor quality assurance standards and standard operating procedures regarding regulatory matters; review safety reports for DAIT-sponsored trials; act as a liaison for regulatory issues with the FDA, international regulatory authorities, and pharmaceutical companies; and coordinate and communicate with other domestic and international government agencies along with other DAIT components to ensure accurate and timely exchange of information on regulatory issues.   Qualifications Candidates must be U.S. citizens and demonstrate that they have worked independently in planning, organizing, and conducting biomedical behavioral health or health-related research and served effectively in research program administration in these fields.   Experience in pharmaceutical drug development and the preparation of submissions to U.S. and/or international health authorities is preferred.   To Apply Visit USAJobs.gov and access the health scientist administrator vacancy announcements NIH-GR-DE-20-10900671 (U.S. citizens) and/or NIH-GR-MP-20-10903705 (status candidates) from September 21 – September 30, 2020 .   For more information about health science administrator positions and qualification requirements, visit Global Recruitment: Recruiting for all of NIH .   Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere!   HHS, NIH, and NIAID are equal opportunity employers committed to equity, diversity, and inclusion.     A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.

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