Research Compliance Spec Sr

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Mission Statement

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 Summary

This position provides regulatory support, consultation, training and FDA liaison support to U-M clinicians requesting Expanded Access (EA) drugs and devices for their patients. This role requires working positively in a team-oriented atmosphere and managing a fast-paced work environment. The successful individual must be able to work independently and to interact with diverse individuals, including physicians, nurses, participants and families, and manufacturer representatives.

Responsibilities*

Responsible for 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.

Required Qualifications*

• 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

Desired Qualifications*

• 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)

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Modes of Work

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.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Background Screening

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.

Application Deadline

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.

U-M EEO Statement

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.