As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world. UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. All of which has allowed the UW to be nationally recognized as a "Great College to Work For" for five consecutive years.The School of Medicine (School) has an outstanding opportunity for a Director of Regulatory Policy.Under the general guidance of the Director of External Business Relations, the Director for Regulatory Policy (Director) advises School leadership, including the Vice Deans, regarding significant regulatory, compliance, business and contracting issues impacting the operations of the School. The Director works to align School operations with School and UW priorities, policies, and budgeting considerations as well as compliance with state and federal laws that apply to the School's educational, research, clinical and related business operations. The Director is responsible for directing regulatory and compliance-related activities for the School. These activities cover a comprehensive range of regulatory and compliance requirements that the School's faculty, staff, students and trainees are subject to, which include areas such as:Clinical and basic science research, clinical billing and documentation, human and animal subjects research, effort certification, export controlsSafety, including environmental health, radiation, select agents, and lab safetyPrivacy and information securityStark and Anti-Kickback, conflicts of interest, open paymentsGraduate medical education, student activities and student recordsScholarly activities, authorship, intellectual propertyInternational activities involving teaching, research and employmentProfessionalism, conduct, ethics, use of state resourcesThe Director's role in leading and managing the School's regulatory and compliance-related activities, includes, but is not limited to the following:Identifying and assessing regulatory and compliance risks that affect the SchoolDeveloping and implementing work plans to address regulatory and compliance risks, and provide regular status reports in close collaboration with School officials, UW Medicine Compliance, and other UW compliance offices. Overseeing implementation of compliance policies and procedures across the School of Medicine.Acting as primary point of contact for the School in receiving inquiries and/or reported regulatory concerns, making appropriate referrals, coordinating/directing investigations, developing and implementing administrative responses to findings of noncomplianceCreating and implementing effective strategies to monitor the School's compliance with compliance policies and regulatory and training requirementsThe School of Medicine is a component entity of UW Medicine that also includes the University of Washington Medical Center (UWMC), Harborview Medical Center (HMC), Northwest Hospital and Medical Center (NWH), UW Neighborhood Clinics (UWNC), UW Physicians (UWP), Valley Medical Center (VMC), and Airlift Northwest. UW Medicine also includes membership in Children's University Medical Group (CUMG) and the Seattle Cancer Care Alliance (SCCA). In addition, UW Medicine has numerous clinical affiliations with other entities such as Seattle Children's Hospital, the Fred Hutchison Cancer Research Center, and the Veterans Affairs Puget Sound Health Care System. UW Medicine's programs include the delivery of clinical services, education of students and trainees, and basic and clinical research programs.Duties & ResponsibilitiesThe Director works closely with the School of Medicine, UW Medicine Compliance and UW offices in developing program goals and policies and implementing/overseeing processes. Representative elements of the Director's duties and responsibilities include the following:Regulatory and Compliance Coordination and Support1. Working as needed with the School, UW Medicine Compliance, and UW offices, develop and implement policies and procedures related to the School's standards of conduct and compliance with applicable laws and regulations, particularly those pertaining to research including research involving humans and animals, safety, healthcare billing and reimbursement, prevention of fraud and abuse, health care privacy, confidentiality, and security, finance and business including Stark and Anti-Kickback, academic, international and other identified areas. 2. Oversee, direct and conduct internal reviews to assess School compliance with applicable laws and regulations.3. Conduct, supervise, coordinate, or support investigations of alleged compliance violations; collaborate and coordinate with School officials and managers to ensure remediation of confirmed non-compliance or potential problems.4. Develop and implement, individually and in collaboration with others, effective compliance-related training and educational programs for SCHOOL faculty and staff; manage compliance with training required and/or provided by others.5. Under the general direction of the Director of External Business Relations, develop periodic compliance reports to UW Medicine senior leadership, and present reports to UW Medicine Compliance and UW Medicine Board committees as appropriate.6. Provide leadership in overseeing reporting system for employees to report concerns and obtain assistance; ensure adequate mechanisms exist .for enforcement of compliance requirements and appropriate disciplinary action in instances of violation of those requirements; serve as referral source and coordination point for and between faculty , staff, students and trainees, departments and School officials, UW Medicine Compliance, and upper campus offices in addressing and answering compliance related complaints. 7. Develop and manage SCHOOL regulatory and compliance resources that are accessible on-line, and coordinate with UW Medicine Compliance regarding content and links to its website.8. Coordinate closely with UW legal counsel, compliance personnel designated by specific School departments, and compliance committees established by the School or specific departments; serve as a member of School, UW Medicine and UW compliance-related committees as appropriate.9. Advise on operational and policy decisions and institutional initiatives that will enhance SCHOOL's programs and their management and administration, and report to the Director of External Business Relations on issues of concern regarding SCHOOL's compliance with federal and state regulations.10. Foster close working relationships with School staff, including Business Unit directors, to address regulatory and compliance issues of mutual concern such as those related to personnel or scientific misconduct matters. 11. Ensure adequate records are maintained to document compliance efforts and corrective actions.12. Collaborate with UW Medicine Compliance to assure overall coordination of UW Medicine Compliance policies, programs, and projects.13. Serve as the School privacy liaison, working closely with the UW Medicine Chief Privacy Officer, to ensure compliance with federal and state requirements related to privacy and information security, actively participate in the management of shared issues and the handling of cross entity incident.14. Communicate, or facilitate communications, with regulatory agencies regarding investigations and alleged violation resolutions.15. Develop and conduct regulatory training, e.g., orientations and department and unit meetings.16. Conduct or participate in conducting risk assessments for targeted compliance focus by the School.Other Regulatory, Contractual, and Related Duties as Assigned1. As requested, provide support to the Director of Regulatory Guidance regarding the review of outside work requests and conflict of interest issues. 2. As requested, participate in negotiating, reviewing, and finalizing goods and services agreements.3. As requested, serve as the School point of contact for the review of data use agreements, non-disclosure agreements, and other miscellaneous agreements involving the School and its departments or faculty.4. Along with the Director of Regulatory Guidance, service as a primary School point of contact for conflict of interest and ethics issues.5. Conduct or participate in personnel related investigations that involve allegations of non-compliance or failure to follow regulations or policies.6. Other duties as assigned.REQUIREMENTSMaster's degree in related field AND five years of progressively responsible experience.Substantial regulatory or compliance experience in government, corporate or university environmentsProven ability to function independently and effectively in a large organizationDemonstrated knowledge of federal and state policies and regulations that pertain to an academic medical environmentA track record of cooperation and creative problem solvingExcellent interpersonal skills and communication skills (written and verbal)Demonstrated ability to work closely, credibly, and collaboratively with others, including faculty (physicians and researchers) and staff, on highly complex mattersProven leadership skills to facilitate solutions-oriented approaches and cooperative decision-makingDemonstrated ability to understand and work with highly ambiguous subject matter and to create and bring consensus among those involved and to facilitate action plansDemonstrated knowledge of and experience with contract negotiation, drafting and executionProven ability to raise and discuss difficult issues and ask probing questions while maintaining professional and collegial working relationshipsEquivalent education/experience will substitute for all minimum qualifications except where there are legal requirements such as license/certification/registration.DESIRED REQUIREMENTSJD DegreeSubstantial experience in an academic medical and research environmentKnowledge of and familiarity with UW School of Medicine, UW Medicine Compliance, and the organization and component entities within UW MedicineCONDITIONS OF EMPLOYMENTMust be available to work evenings and weekends as required.Application Process:The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select "Apply to this position". Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your "My Jobs" page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.