Senior Ethics & Compliance Specialist Regulatory Support Manager

AVC Ethics & Compliance

Full Time

78557BR

Job Summary

The Senior Ethics & Compliance Specialist/Regulatory Support Manager is a subject matter expert on FDA regulations, the university’s policies, processes, and standards. The Senior Specialist serves as leader within the Office of Ethics and Compliance (OEC) and serves as a resource to the greater university community; coordinates oversight and compliance activities with other units across UCSF; and communicates compliance obligations while assisting faculty and staff in translating compliance requirements and expectations into their daily work. The Senior Specialist also provides thought leadership on addressing evolving internal and external compliance concerns and changes in regulatory or policy requirements.

The Senior Specialist independently oversees, advises, and manages the activities of the Regulatory Support unit and the ClinicalTrials.gov unit within OEC. The Senior Specialist is responsible for effective functional area management, long-range planning for improvement of operational efficiencies and establishing strategic directions for comprehensive regulatory consultation and clinicaltrials.gov programs. The Senior Specialist manages daily operations of these two units, including the deployment of technology and web content to support and advance compliance services. The Senior Specialist also drives process enhancements and efficiencies and proposes and implements training of all relevant stakeholders. The Senior Specialist directly supervises the Regulatory Specialists.

This role requires the incumbent to also provide administrative, regulatory and policy support across all functional units within the Office of Ethics & Compliance (OEC), as needed. These functional units include Conflict of Interest in Research, Investigations Unit, Export Control, Research Integrity, and Regulatory Support.

The final salary and offer components are subject to additional approvals based on UC policy.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)

Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

Department Description

The Office of Ethics and Compliance (OEC) collaborates with the UCSF community and senior leadership to provide oversight and guidance to compliance functions across the enterprise. Our mission is to foster a culture of compliance, which leads to compliant and ethical behavior across all university functions and activities. The OEC organization includes the following units: Investigations Unit; Conflict of Interest in Research; Export Control; Regulatory Support; and Research Integrity

Required Qualifications

• Bachelor's degree in related area and / or equivalent experience / training
• Six years of practical experience in the application of FDA regulations, ethics and compliance policies, procedures, and programs in an institution of higher education
• Expert knowledge of the ethics and compliance profession, theories and systems of internal control, and professional compliance standards
• Ability to assume ownership of regulatory consultation, clinicaltrials.gov and drive best practices across the university
• Ability to gather, organize, analyze, and report on issues and recommendations that are complex in nature
• Excellent interpersonal skills to work independently with all levels of University personnel, including management and faculty, and to facilitate agreement on issues and corrective actions
• Ability to communicate complex information to all levels of management and administrators in a clear and concise manner both written and verbal
• Excellent skills in complex decision making on critical issues
• Excellent skills in presenting information in a relevant, thorough, and complete manner

Preferred Qualifications

• Master’s degree or JD
• Professional certification(s) applicable to job responsibilities preferred

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Job Code and Payroll Title

006059 ETHICS AND CMPLNC MGR 1

Job Category

Legal Services, Professional (Non-Clinical)

Bargaining Unit

99 - Policy-Covered (No Bargaining Unit)

Location

Flexible (combination of onsite and remote work), Mission Bay (SF)

Additional Shift Details

Monday - Friday; 8AM- 5PM PST, Hybrid work model