UCSF Health
Senior Ethics & Compliance Specialist Regulatory Support Manager
UCSF Health, San Francisco, California, United States, 94199
Senior Ethics & Compliance Specialist Regulatory Support Manager
AVC Ethics & Compliance
Full Time
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.
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.
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.
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.
Work Location:
Hybrid remote in San Francisco, CA 94158
#J-18808-Ljbffr
AVC Ethics & Compliance
Full Time
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.
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.
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.
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.
Work Location:
Hybrid remote in San Francisco, CA 94158
#J-18808-Ljbffr