Research Compliance Spec Sr

the management and oversight of expanded access approvals for investigational drugs, devices, or biologics. This includes the following duties: Prepare and submit single and multi-patient expanded access INDs and related submissions including responses to FDA inquiries, safety reports, and other life-cycle maintenance submissions to FDA Liaise with manufacturers on behalf of UM physicians, both to obtain manufacturer approval for EA cases and to complete requirements for compassionate use to medical devices Assure regulatory compliance for EA submissions via Support for UM physicians and clinical teams to provide regulatory guidance and expertise Preparation of IRB documentation for EA cases including drugs, biologics, and medical devices, including applications, informed consent documents, and maintenance requirements Critical review of submission documents such as treatment protocols and informed consent documents to ensure compliance with regulatory requirements Contribute to patient care coordination by interacting with providers, clinical and regulatory stakeholders, and patients and families as required. Provide logistical and regulatory coordination for industry-sponsored multiple-patient expanded access programs, including maintenance of regulatory binders and related documentation, data entry, initiation of supply shipments, and patient enrollment Work collaboratively across departments to assure optimal care of EA patients Assist in providing regulatory education and training to physicians, clinical teams, and other research/regulatory/clinical personnel Demonstrate strong knowledge of the regulatory process and works toward process efficiency for all team members. Contribute to continuous quality improvement through identification of opportunities and implementation of solutions. Other duties as assigned. Bachelor's degree in a related field 5 or more year's experience in the medical device, pharmaceutical and/or regulatory field. Organizational and problem-solving skills Excellent interpersonal and communication skills. Ability to work positively in a team-orientated atmosphere and manage a fast paced work environment. Ability to successfully interact with diverse individuals, including investigators, nurses, participants and families, and industry and sponsor representatives Excellent computer skills Understanding of the clinical research environment, as demonstrated by previous work in clinical trials/regulatory affairs and/or related certifications (CCRC, CCRP, RAC, etc.) 2-5 years' experience in the regulatory field, specifically in the submission of IND's and IDE's, or experience with filing an NDA, BLA, PMA or 510(k) This position may be underfilled at a lower classification depending on the qualifications of the selected candidate. 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. 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. 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 Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.