Legal Career Center

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.

The School of Medicine has an outstanding opportunity for a Director of Contracting and Regulatory Affairs to join their team.

The Director of Contracting and Regulatory Affairs (payroll title: Director) is responsible for School of Medicine (SoM) business administration operations related to a wide-range of external business relationships and complex contractual matters, including research-related business agreements, research affiliation agreements, licensing and intellectual property issue review, facility arrangements, non-clinical goods and services contracts, confidentiality and non-disclosure agreements, data transfer agreements, material transfer agreements involving the transfer of human biological specimens, medical education affiliations, business related compliance issues, clinical services agreements, outside work and selected matters involving faculty and staff.

The Director is part of the SoM Business Unit led by the Associate Vice Dean for Business & Regulatory Affairs. The Business Unit reports to the Clinical Business and Regulatory Affairs Officer, UW Medicine; Associate Vice President for Medical Affairs, University of Washington, with a secondary reporting relationship to the Vice Dean for Administration and Finance. Business Unit staff provide advice, assistance and resources to SoM administrators and units on a wide range of business, contractual, regulatory, personnel and record management matters.

This position serves as the lead for the Contracting and Regulatory Unit (CRU) team within the Business Unit, which manages and provides guidance on business, contractual and regulatory matters for the SoM, including goods and services agreements, clinical and education agreements, data use agreements, non-disclosure agreements, outside work requests and compliance matters. The Director handles a related contracting and/or regulatory workload and provides oversight to CRU directors and administrative staff.

Position Complexities
This position is within the SoM, a major school within the University of Washington, a large, complex, and high-ranking institution of higher education and nationally and internationally recognized for excellent programs in clinical care, teaching and research activities. The SoM has 31 academic departments with over 1,700 teaching and research faculty, 4,000 clinical faculty, 700 research and training fellows, and administrative support staff.

The SoM also is a component entity of UW Medicine--an integrated clinical, research and learning health system comprised of multiple entities with a single mission to improve the health of the public. In addition to the SoM, the following entities are considered to be clinically integrated parts of UW Medicine: University of Washington Medical Center (UWMC) – Montlake and Northwest campuses, Harborview Medical Center (HMC), Fred Hutchinson Cancer Center (Fred Hutch), UW Primary Care (UWPC), UW Physicians (UWP), Valley Medical Center (VMC) and Airlift Northwest. UW Medicine also shares in the governance of Children’s University Medical Group (CUMG). In addition, UW Medicine has numerous clinical affiliations with other entities such as Seattle Children’s Hospital and the Veterans Affairs Puget Sound Health Care System. The Director is expected to understand and navigate the intersection between SoM education, clinical and research activities, the UW and UW Medicine’s clinical operations.

Position Dimensions and Impact to the University
As a leader in the Business Unit, the Director is accountable for maintaining a culture of professionalism that upholds and strengthens the values set forth in the UW Medicine Policy on Professional Conduct, including equity, diversity and inclusion. The Director is expected to have substantive managerial and business skills, a customer service focus, and a demonstrated ability to work closely and collaboratively with UW, UW Medicine and SoM administrators, faculty and staff. The Director must have a strong knowledge base of state and federal laws and UW policies that relate to the work of the position and the work of the CRU team. The Director must be able to oversee and provide supervision to subordinate professional staff, as well as elevate significant issues and matters to the Associate Dean and other SoM leadership, including the vice deans.

The Director is expected to manage a high volume of diverse assignments that range in complexity and involve a diverse set of constituent groups, including peers and leadership across the SoM, UW Medicine and the UW. The Director must manage that workload with attention to detail and competing deadlines, as well as provide clear communication with status updates and involve key stakeholders in decision-making. The Director must work to align SoM operations with SoM, UW Medicine and UW priorities, policies, and budgeting considerations, as well as adhere to state and federal laws that apply to the SoM’s educational, research, clinical and related business operations.

DUTIES AND RESPONSIBILITIES
The Director of Contracting and Regulatory Affairs has direct management responsibility for selected SoM business operations. The Director is the lead of the CRU team, providing oversight and guidance to its members and the work of CRU. This person directly supervises an Assistant to Director, the Director of Regulatory Policy, the Director of Regulatory Projects, the Director of Regulatory Guidance and the Director for Clinical Services Projects.

Representative elements of the responsibilities and corresponding duties include the following:

Contracting and/or Regulatory Work Portfolio
In addition to oversight and managerial responsibilities related to the CRU team, the Director has direct responsibility for a portfolio of CRU work that includes business, contracting, regulatory and/or compliance activities, including a mix of the activities listed below. It is not anticipated that the Director will assume all of these responsibilities. Assignment of work will depend on the needs of the Business Unit, the CRU team and the background and experience of the Director. Responsibilities not assumed by the Director will be assigned or delegated to other directors on the CRU team:
•Draft and review documents and provide advice, in consultation with legal counsel, on business issues within SoM, including issues related to business risk, contracting, intellectual property, real estate, leasing and tax.
•Draft and negotiate certain agreements, such as affiliation and similar agreements involving research and graduate education, including their intellectual property aspects, in collaboration with the Vice Dean for Research and Graduate Education, as well as central UW offices such as the Office of the Vice Provost, CoMotion and the Attorney General’s Office.
•Draft and negotiate complex and select goods and services agreements.
•Review selected data use agreements (DUA), non-disclosure agreements (NDA), material transfer agreements (MTA) and other agreements related to goods and services agreements or SoM projects.
•Work with SoM and department administrators to manage and resolve external business disputes, including those related to purchasing and industry sponsored research.
•As requested, provide regular reports to central UW regarding SoM contracts, e.g., foreign entity contracts.
•Collaborate within the SoM and across the UW to develop policy and operational guidance, including managing projects in areas involving federal and state laws and UW policies and regulations related to business operations.
•Participate in identifying and assessing regulatory and compliance risks that affect the SoM.
•Work closely with SoM officials, UW Medicine Compliance and other UW compliance offices to develop and implement work plans to address compliance risks and provide regular status reports.
•Coordinate closely with UW legal counsel to analyze and evaluate risks and compliance concerns.
•Oversee implementation of compliance policies and procedures in the SoM.
•Receive inquiries and/or reported concerns, make appropriate referrals, coordinate investigations, participate in developing and implementing administrative responses to findings of noncompliance.
•Develop and implement effective strategies to monitor the SoM's compliance with compliance policies and regulatory and training requirements.
•Serve as a consultant on regulatory and compliance matters to departments and units within SoM.
•Provide compliance reports to upper management and prepare and deliver reports to UW Medicine Compliance and UW Medicine Board committees as appropriate.
•Work closely with SoM staff, including Business Unit directors, on regulatory and compliance issues of mutual concern such as those related to personnel, outside work or scientific misconduct matters.
•Communicate, or assist in communications, with regulatory agencies regarding investigations and alleged violation resolutions.
•Develop and conduct regulatory training, e.g., orientations and department and unit meetings.

Business Relations and Contracting
•Provide direct guidance and involvement in business and contractual matters that arise within SoM.
•Provide oversight and guidance to other CRU directors regarding agreements for the sale of departmental goods and services and other agreements, ensuring compliance with regulations and laws impacting such agreements, such as privacy, intellectual property, taxation and liability.
•Provide oversight and guidance to other CRU directors on clinical and educational services agreements involving services provided by SoM clinical faculty across the UW Medicine entities, and to external entities including federal, state and local governments.
•Facilitate coordination regarding SoM clinical contracts with department and division leadership, UWP, CUMG and SoM Sites of Practice approval processes; and provide oversight on process improvements including data tracking, templates and clinical contracting process guidelines.

Regulatory and Compliance Matters
•Provide direct guidance and involvement in compliance and regulatory matters that arise within SoM.
•Provide oversight and guidance to other CRU directors regarding compliance and regulatory matters that arise within SoM, including conflicts of interest, ethics, research, health and safety, open payments reporting, pre and post award research grants and contracts.
•Provide oversight and guidance to other CRU directors regarding the outside work approval processes and considerations, and compliance with research and privacy regulations.
•Ensure coordination with UW Medicine Compliance on SoM compliance-related issues.

Other Duties
•Uphold and strengthen the values set forth in the UW Medicine Policy on Professional Conduct, including creating and maintaining a working environment that is diverse, inclusive, equitable and welcoming.
•Increase the engagement of the CRU team and the Business Unit in dismantling systemic racism and supporting healthcare equity and justice across the UW Medicine system.
•Manage and supervise CRU team members and the work of CRU, providing guidance on prioritization of assignments, backup plans and effective use of resources.
•Participate in recruitment and onboarding of new CRU team members.
•Serve as a member of the Business Unit Leadership Team (BULT), providing input and guidance regarding management and operations issues impacting the Business Unit.
•Oversee the management of contracts and provide input on contract management systems for use within the Business Unit and as a resource for others in the Dean’s Office.
•Oversee management and operations of the outside work approval process.
•Serve on committees as assigned.
•Provide trainings and presentations to various groups on the subjects and topics within the Director’s responsibility.
•Collaborate with and assist with the work of other Business Unit directors, as appropriate or as requested by the Associate Dean.
•Other duties as assigned.

MINIMUM QUALIFICATIONS
•Master’s degree in health care administration, business administration or a related field.
•Minimum 5-years professional experience; senior managerial and/or administrative experience in an academic, governmental, or healthcare environment, with extensive oversight responsibilities.

Additional requirements:
•Proven ability to function independently and effectively in a large organization.
•A track record of creative problem solving and facilitating solutions-oriented approaches.
•Excellent interpersonal skills and communication skills (written and oral).
•Excellent analytical and organizational abilities.
•Highly refined sense of diplomacy.
•Demonstrated ability to work closely, credibly and collaboratively with others including institutional leadership, faculty (physicians and researchers) and staff.
•Demonstrated competence in knowledge and interpretation of institutional policies and applicable state and federal rules and regulations related to contracting, compliance, ethics, conflicts of interest and professionalism.

Equivalent education and/or experience may substitute for minimum requirements.

DESIRED QUALIFICATIONS
•Law Degree (JD).
•Supervisory experience.
•Knowledge of and familiarity with UW School of Medicine and UW Health Sciences colleges and departments, as well as a general understanding of the organization and clinically integrated entities within UW Medicine, as well as affiliated entities.
•Experience in a university setting or clinical, research or regulatory environment.
•Experience providing support in academic contractual, clinical or regulatory matters.

WORKING ENVIRONMENTAL CONDITIONS
•The person who holds this position will be based in SoM-assigned facilities at the Health Sciences Building on the UW Seattle campus.
•Office environment, with hybrid in-person/remote schedule available, subject to approval and conditioned on meeting business needs.
•Must be able to work additional hours, including evenings and weekends, as required for business needs.

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.