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 describe the skills and experience that directly relate to this role. Applicants should highlight relevant experience with academic clinical research, investigator-initiated research, and clinical research involving Investigational New Drug applications (INDs) or Investigational Device Exemptions (IDEs), research compliance, or regulatory affairs.

The Michigan IND/IDE Investigator Assistance Program (MIAP) in the University of Michigan Medical School Office of Research is seeking an experienced regulatory professional to join our team. The position may be filled at either the Senior Regulatory Project Manager level (Research Compliance Specialist Senior) or the Regulatory Project Manager level (Research Compliance Specialist Intermediate), depending on the qualifications and experience of the selected candidate.

MIAP provides comprehensive regulatory support, guidance, and education to University of Michigan sponsor-investigators conducting investigator-initiated, FDA-regulated clinical research across all therapeutic areas. We support research involving investigational drugs, biologics, medical devices, and combination products from regulatory strategy development through study closeout, with a focus on the preparation and maintenance of Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications.

This role involves managing complex regulatory projects, working with investigators and research teams, and communicating directly with the FDA. Responsibilities include preparing IND and IDE applications and lifecycle submissions, exemption and device risk determination requests, FDA meeting requests and briefing packages, and responses to FDA inquiries. The role also includes reviewing protocols, informed consent documents, and supporting materials; providing regulatory and operational guidance; supporting U-M institutional review boards, including review of applicable drug, biologic, and device submissions in eResearch; participating in consultations and educational activities; and developing regulatory tools, templates, procedures, and training resources.

This work requires a strong understanding of clinical research and the regulatory framework governing FDA-regulated studies, intellectual curiosity, critical thinking, careful attention to detail, and the ability to translate complex and evolving requirements into clear, practical, and well-reasoned guidance.

MIAP is a collaborative and supportive team that values open discussion, shared learning, and thoughtful problem-solving. Team members manage their work independently while drawing on one another's expertise to address challenging regulatory questions and support innovative medical research at the University of Michigan.

Research Compliance Specialist Senior Responsibilities

Regulatory Project Management 80%

• Prepare and submit INDs, IDEs, IND exemption requests, device risk determination requests, and related regulatory submissions

• Prepare FDA meeting packages, responses to FDA inquiries, amendments, safety reports, annual reports, and other lifecycle submissions

• Critically review regulatory documents, clinical protocols, informed consent documents, and supporting materials for completeness and compliance with applicable requirements

• Develop and provide regulatory and operational guidance to investigators and multidisciplinary project teams

• Interpret and apply University policies and federal regulations to complex research projects

• Collaborate with U-M institutional review boards, Clinical Trials Support Units, the Office of Research and Sponsored Projects, and research consortia to support coordinated regulatory oversight

• Monitor and interpret changes in FDA regulations and guidance and communicate relevant updates to investigators, research teams, and other partners

Education and Consultations 15%

• Provide regulatory expertise and support to U-M institutional review boards, including review of applicable drug, biologic, and device submissions in eResearch

• Provide regulatory education and training to investigators, sponsor-investigators, and other clinical research and regulatory personnel

• Provide consultation and guidance to investigators and study teams regarding regulatory issues in clinical research and product development

• Participate in professional development and maintain engagement with national regulatory support organizations

Medical Writing and Editing 5%

• Create and revise standard operating procedures, tools, templates, guidance documents, and educational materials

• Review and edit manuscripts, posters, presentations, and abstracts, as appropriate

Research Compliance Specialist Intermediate Responsibilities

Regulatory Project Management 80%

• Assist with the preparation and submission of INDs, IDEs, IND exemption requests, and device risk determination requests under the guidance of senior regulatory staff

• Assist with FDA meeting packages, responses to FDA inquiries, amendments, safety reports, annual reports, and other lifecycle submissions

• Review clinical protocols, informed consent documents, and supporting materials for regulatory completeness and compliance

• Provide regulatory and operational support to investigators and multidisciplinary research teams

• Apply knowledge of University policies and federal regulations to assigned regulatory work

• Collaborate with U-M institutional review boards, Clinical Trials Support Units, the Office of Research and Sponsored Projects, and research consortia to support coordinated regulatory oversight

• Monitor changes in FDA regulations and guidance with support from senior regulatory staff and communicate relevant updates to project teams

Education and Consultations 15%

• Participate in regulatory consultations and provide support to investigators and study teams

• Assist with regulatory education and training for investigators, sponsor-investigators, and other clinical research and regulatory personnel

• Participate in professional development

Medical Writing and Editing 5%

• Assist with creating and revising standard operating procedures, tools, templates, guidance documents, and educational materials

• Review and edit manuscripts, posters, presentations, and abstracts, as appropriate

Research Compliance Specialist Senior Required Qualifications

• Bachelor's degree in a scientific or technical discipline, or an equivalent combination of education and experience

• Five or more years of professional experience in research compliance, FDA-regulated research administration, or a related area, or an equivalent combination of education and experience

• Excellent understanding of clinical research and knowledge of FDA regulations, policies, and guidance applicable to investigational drugs, biologics, and medical devices

• Ability to evaluate relevant information, apply appropriate regulatory principles, and exercise sound judgment

• Strong attention to detail and organizational skills

• Ability to manage complex regulatory work independently and responsibly with minimal supervision

• Ability to collaborate effectively with colleagues and partners across the organization

• Strong written and verbal communication skills across a variety of professional settings and audiences

• Advanced knowledge of medical and scientific terminology

Research Compliance Specialist Intermediate Required Qualifications

• Bachelor's degree in a scientific or technical discipline, or an equivalent combination of education and experience

• At least two years of experience in research compliance, FDA-regulated research administration, regulatory affairs, or a related field, or an equivalent combination of education and experience

• Strong foundation in clinical research and working knowledge of FDA regulations, policies, and guidance applicable to investigational drugs, biologics, and medical devices

• Ability to evaluate relevant information and apply established regulatory principles and decision-making criteria

• Strong attention to detail and organizational skills

• Ability to work independently on assigned responsibilities while seeking guidance when appropriate

• Ability to collaborate effectively with colleagues and partners across the organization

• Strong written and verbal communication skills across a variety of professional settings

• Proficiency with medical and scientific terminology

Research Compliance Specialist Senior Desired Qualifications

• Direct experience preparing and submitting INDs, IDEs, or related FDA submissions

• Experience applying University policies and federal regulations in an academic research environment

• Regulatory Affairs Certification (RAC-Drugs or RAC-Devices), or an advanced degree in regulatory affairs or a related field

Research Compliance Specialist Intermediate Desired Qualifications

• Experience assisting with preparing and submitting INDs, IDEs, or related FDA submissions

• Experience applying University policies and federal regulations in an academic research environment

• Regulatory Affairs Certification (RAC-Drugs or RAC-Devices), or an advanced degree in regulatory affairs or a related field

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.

This position is posted at the Research Compliance Specialist Senior level and may be underfilled at the Research Compliance Specialist Intermediate level 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 Reporting Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments and transfers from other U-M campuses.

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.