A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Michigan Medicine improves the health of patients, populations, and communities through excellence in education, patient care, community service, research, and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

The Michigan Institute for Clinical & Health Research (MICHR) is the home of the University of Michigan's Clinical and Translational Science Award from the National Institutes of Health. MICHR is part of a national, collaborative consortium that is focused on delivering more treatments to all people more quickly by advancing clinical and translational science (CTS). The field of CTS aims to build an evidence base of scientific and operational approaches that improve the efficiency, effectiveness, and impact of translational research across a range of diseases and conditions. MICHR has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist; developing novel solutions to these challenges; demonstrating their effectiveness; and disseminating improvements widely. MICHR is a dynamic organization that serves as a hub of innovation and experimentation to advance research in the science of translation and accelerate the realization of interventions that improve human health.

MICHR is seeking a Research Compliance Specialist Lead to provide leadership, mentorship, and advanced regulatory expertise within the IND/IDE Investigator Assistance Program (MIAP). This position provides regulatory consultation, education, training, and FDA liaison support to University of Michigan investigators conducting FDA-regulated clinical research involving investigational drugs, devices, and biologics.

The individual in this role will possess advanced technical expertise in FDA regulatory requirements and sponsor-investigator responsibilities, including management of IND and IDE submissions and maintenance activities. The position also provides functional leadership and mentorship to MIAP staff, supports operational initiatives, quality improvement activities, development of SOPs and educational resources, and institutional regulatory compliance efforts. Additional responsibilities include collaborating with internal regulatory and research support partners and serving as a subject matter expert on FDA-regulated clinical research and sponsor-investigator responsibilities.

50% Leadership, Mentorship & Program Operations

• Provide functional leadership, mentorship, onboarding, and training to MIAP Research Compliance Specialists

• Assist Program Director with development and implementation of operational initiatives and strategic program activities

• Identify programmatic strengths and improvement opportunities and collaborate on continuous quality improvement initiatives

• Lead development, implementation, and maintenance of SOPs, templates, tools, and standard practice documents

• Support operational consistency, quality assurance, and regulatory best practices across MIAP activities

• Serve as a liaison to internal partners to support efficient operational workflows, as assigned by Program Director

40% Regulatory Submissions, FDA Communication & Consultation

• Manage and oversee UM Sponsor-Investigator FDA regulatory activities for clinical research involving investigational drugs, devices, and biologics, including INDs and IDEs
• Author, prepare, and contribute to FDA submissions including INDs, IDEs, pre-submissions, meeting requests, responses to FDA inquiries, amendments, annual reports, and lifecycle maintenance submissions
• Communicate directly with FDA regarding regulatory submissions
• Provide regulatory guidance, consultation, and strategic support to UM sponsor-investigators and study teams
• Critically review clinical protocols, informed consent documents, eResearch applications, and related materials to ensure compliance with applicable regulations and institutional requirements
• Collaborate with IRBMED, CTSU, ORSP, Regulatory Affairs, Office of General Counsel, and research consortiums to support coordinated regulatory oversight
• Monitor and interpret evolving FDA regulations, guidance documents, and enforcement trends and communicate relevant updates to stakeholders
• Provide regulatory guidance and consultation on FDA regulations for internal units, such as Institutional Review Board (IRB), Human Research Protection Program (HRPP) related units, Clinical Trials Support Units, Regulatory Affairs, Office of General Counsel and others as needed, including eResearch review for applicable drug/device/biologic applications
• Assist in providing regulatory education and training to investigators, sponsor-investigators, monitors and other research/regulatory personnel
• Provide guidance and support to investigators and study teams related to regulatory issues in product development
• Works with other program staff, developing and presenting educational materials
• Serve as subject matter expert for applicable FDA regulations and interactions for the institution
• Collaborate with program director and other research/regulatory personnel to develop CAPA plans for institutional compliance concerns 

10% Education and Consultation

• Provide regulatory guidance and consultation on FDA regulations for internal units, such as Institutional Review Board (IRB), Human Research Protection Program (HRPP) related units, Clinical Trials Support Units, Regulatory Affairs, Office of General Counsel and others as needed, including eResearch review for applicable drug/device/biologic applications
• Assist in providing regulatory education and training to investigators, sponsor-investigators, monitors and other research/regulatory personnel
• Provide guidance and support to investigators and study teams related to regulatory issues in product development
• Works with other program staff, developing and presenting educational materials
• Serve as subject matter expert for applicable FDA regulations and interactions for the institution
• Collaborate with program director and other research/regulatory personnel to develop CAPA plans for institutional compliance concerns 

• Bachelor's Degree in a scientific or technical discipline 
• At least 10 years of experience working in Clinical Research and/or Regulatory Affairs
• Minimum of three (3) years of experience managing Sponsor-Investigator FDA regulatory submissions for clinical research involving drugs, devices, and/or biologics, including INDs and IDEs, and preparing related FDA submissions and maintenance documents

• Regulatory Affairs Certification (RAC) or willingness to pursue certification
• Experience working within an academic medical center or research institution
• Expert knowledge of FDA regulations governing sponsor-investigator research involving drugs, devices, and biologics
• Experience providing regulatory consultation, education, and training to investigators, study teams, and research personnel

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Note:  This position is remote.

Benefits

We offer a benefits package that includes comprehensive training and career development opportunities, generous retirement savings plans, ample paid time off, and a wealth of family care support: https://careers.umich.edu/benefits 

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.

The University of Michigan is an equal opportunity/affirmative action employer.