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DIRECTOR OF CLINICAL REGULATORY AFFAIRS AND ASSOCIATE GENERAL COUNSEL

University of Washington

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.

UW Medicine has an outstanding opportunity for a Director of Clinical Regulatory Affairs and Associate General Counsel to join their team.

GENERAL DESCRIPTION AND PURPOSE

The Director of Clinical Regulatory Affairs (Director), Associate General Counsel for UW Medicine Nonprofit Entities and CUMG (AGC) has a dual role under both the UW Medicine Clinical Regulatory Affairs Office and the General Counsel’s Office for the UW Medicine Nonprofit Entities and Children’s University Medical Group, and reports to the Assistant Vice President for Medical Affairs, University of Washington, Senior Director of Business & Regulatory Affairs, UW Medicine, General Counsel for UW Medicine Nonprofit Entities (“Senior Director/General Counsel”). The UW Medicine Clinical Regulatory Affairs Office is part of the UW Medicine Clinical Business and Regulatory Affairs Office reporting to the Clinical Business and Regulatory Affairs Officer.

UW Medicine’s programs include the provision of medical care to underserved and disadvantaged persons and maintaining the economic vitality of UW Medicine’s owned and managed health system. UW Medicine’s delivery of its core programs is via a complex organization including the School of Medicine, University of Washington Medical Center, Harborview Medical Center, Valley Medical Center, UW Medicine Primary Care, Airlift Northwest, Fred Hutchinson Cancer Center, UW Physicians, Children’s University Medical Group as well as affiliated organizations including Seattle Children’s Hospital, Veterans Affairs, LifePoint-UW Medicine Healthcare Holding Company and the Pacific Northwest Clinically Integrated Network.

General Counsel’s Office:

Under the general supervision of the General Counsel, the AGC will provide a wide array of legal services to UW Physicians (“UWP”), UW Physicians Network dba UW Medicine Primary Care (“UWMPC”), and Children’s University Medical Group (“CUMG”). This position will advise on all aspects of specific operations, including legal issues related to hospital and medical center operations, medical staff matters, government healthcare program regulations, business practices, and the operation of nonprofit, and tax-exempt healthcare entities. The Associate General Counsel will participate in drafting contracts, assist with policy development, provide legal advice on a range of operational and business matters, and support billing compliance program activities. This position also will provide advice regarding employment and benefits for administrative staff, employed medical staff, practice plan physicians, and other healthcare professionals.

Clinical Regulatory Affairs:

Under the general guidance of the Senior Director, the Director is primarily responsible for the strategic and operational management and oversight of UW Medicine’s clinical regulatory affairs, including associated regulatory and legal affairs, in support of UW Medicine’s mission.

UW Medicine’s programs include the delivery of advanced medical diagnostics and treatment services, clinical support for the education of medical students and graduate and postgraduate trainees, and maintenance of one of the largest and most advanced university-based basic and clinical research programs in the United States.

UW Medicine’s programs also include the provision of medical care to underserved and disadvantaged persons and maintaining the economic vitality of UW Medicine’s owned and managed health system.

UW Medicine’s delivery of its core programs is via a complex organization including the School of Medicine, University of Washington Medical Center, Harborview Medical Center, Valley Medical Center, UW Medicine Primary Care, Airlift Northwest, Fred Hutchinson Cancer Center, UW Physicians, Children’s University Medical Group as well as affiliated organizations including Seattle Children’s, Veterans Affairs, LifePoint-UW Medicine Healthcare Holding Company and the Pacific Northwest Clinically Integrated Network.

The Director is accountable directly to the Senior Director for the management of UW Medicine clinical business and regulatory affairs to support the activities of UW Medicine leadership, including the UW Medicine Clinical Business and Regulatory Affairs Officer and Associate Vice President for Medical Affairs, University of Washington; the Chief Business Officer, UW Medicine, Chief of Staff, UW Medicine and Vice President for Medical Affairs, University of Washington; the President of Hospitals & Clinics, UW Medicine and Vice President for Medical Affairs, University of Washington; the Chief Financial Officer, UW Medicine and Vice President for Medical Affairs, University of Washington; the Chief Medical Officer, UW Medicine and Vice President for Medical Affairs, University of Washington; and the CEO, UW Medicine, Executive Vice President for Medical Affairs and Dean of the School of Medicine, University of Washington.

DUTIES AND RESPONSIBILITIES

General Counsel’s Office:

While not exhaustive, the following are representative elements of the AGC’s duties and responsibilities:

  • Provide formal and informal advice to management on a wide range of corporate and business legal issues (e.g., corporate bylaws, contracting, tax issues, employment/employee benefits, etc.).
  • Provide formal and informal advice to management on a wide range of healthcare regulatory issues (e.g., Stark and Anti-Kickback laws, EMTALA, HIPAA, Medicare and Medicaid billing regulations, etc.).
  • Draft and/or review contracts and other business documents.

Help guide client entity compliance programs, to assure conformity with Medicare and Medicaid billing requirements.

  • Periodically attend and provide advice at governing board and committee meetings.
  • Coordinate with legal counsel representing the other components of UW Medicine on matters of joint interest to the health system.
  • Perform other duties, as assigned.

Clinical Regulatory Affairs:

The Director is accountable directly to the Senior Director of Business and Regulatory Affairs for the management of UW Medicine clinical business and regulatory affairs, including associated regulatory and legal affairs and supports the activities of UW Medicine leadership identified above. Representative elements of the Director’s duties and responsibilities include the following:

External Business Relationships:

The Director participates in the development, negotiation and maintenance of UW Medicine contractual relationships with external entities, including the following:

  • Serve as a UW Medicine representative in external conversations with prospective business partners, regulatory agencies or others on behalf of UW Medicine.
  • Work in close partnership with UW Medicine leaders to support external relationships.
  • Other special projects as assigned.

Internal Business Processes:

The Director provides leadership and direction in policy formulation and implementation in areas involving UW Medicine faculty and staff, and UW Medicine and University business processes including the following:

  • Participate and provide leadership in the development of UW Medicine policies and procedures and in particular policies that impact provider credentialing and faculty practice plans;
  • Partners with UW Medicine offices on regulatory investigations;
  • Provides leadership on patient nondiscrimination issues;
  • Provide leadership on non-profit corporate governance.

Regulatory Compliance and Legal Affairs:

The Director participates in the management of UW Medicine regulatory compliance efforts and provides technical advice related to:

  • Legal and regulatory compliance matters that impact UW Medicine and its entities and affiliates;
  • Compliance with federal laws and regulations, Washington State laws and regulations, and UW rules and regulations related to all areas of UW Medicine operations;
  • Issues unique to physician compensation, faculty practice plans, Stark law and general fraud and abuse prevention regulations;
  • Issues pertaining to UW Medicine’s requirements to provide equal access to care for all patients, regardless of their race, disability status or other protected classification;
  • Working closely with the UW Medicine Senior Director of External Affairs, proactively monitor federal, state and local government regulations, legislation and laws that affect UW Medicine and brief UW Medicine leadership on the application of such laws, including the preparation of comments in rulemaking.

JOB CHARACTERISTICS

The Director/AGC is responsible for strategic involvement in UW Medicine business and regulatory affairs, personnel policy, compliance, and legal affairs. The Director/AGC is required to possess a comprehensive knowledge of:

  • UW Medicine practices, policies, and key issues impacting its clinical regulatory and legal affairs.
  • Federal and State laws and regulations and UW rules, regulations and policies affecting UW School of Medicine faculty, staff, programs and business affairs.
  • All aspects of healthcare delivery in compliance with applicable regulations such as the Stark law, Anti Kickback Statute, and the False Claims act.
  • The Director/AGC will have frequent written and oral interactions with senior executives and professional staff within UW Medicine and UW.

MINIMUM QUALIFICATIONS

  • A Juris Doctor degree and a license to practice law in the State of Washington are required.
  • Minimum 7 years healthcare law experience, including experience providing legal advice to hospitals and medical centers.

Equivalent education/experience will substitute for all minimum qualifications except where there are legal requirements such as license/certification/registration.

DESIRED QUALIFICATIONS

  • Experience as in house or established legal counsel to a hospital or medical center.
  • Experience with tax-exempt entities.
  • Exceptional written and oral communication skills.
  • A quick study, with excellent analytic and advising skills.
  • Maturity/demonstrated ability to work effectively and collaboratively in a highly complex academic medical center environment.
  • Hard working, organized and able to manage multiple matters simultaneously and effectively.
  • Demonstrated commitment to team-orientation and strong client service.
  • An awareness of the national, regional and local regulatory compliance challenges facing academic medical centers.
  • Familiarity with the contractual business issues that arise in the normal course of academic medical center activities.

COMPLIANCE REQUIREMENTS

The AGC/Director position requires adherence to the UW Medicine Code of Conduct and UW Medicine and UWP and CUMG Billing Compliance Policies and related training requirements. Incumbents must demonstrate knowledge and understanding of the confidentiality of employee information, UWP, CUMG and UWMPC plans, initiatives, and financial information, and patient privacy rights. Job duties must be performed with minimum access to and use of employee and/or patient information. Incumbents are required to engage in active discussion with subordinates and other workforce members on the requirements for reporting of compliance concerns and the company’s commitment to non-retaliation for reporting such concerns. Incumbents must promptly report all compliance concerns.

CONDITIONS OF EMPLOYMENT

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.

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Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

The University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu.

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.

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Confirmed an hour ago. Posted 26 days ago.

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