How to Apply
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.
- Support UM sponsor-investigators, study teams and other research support units to provide regulatory guidance and expertise
- Responsible for the preparation and submission of Investigational New Drug (IND) Applications and Investigational Device Exemption (IDE) Applications
- Prepare and contribute to IND and IDE filings and related submissions including preparation of meeting packages, responses to FDA inquires and life-cycle maintenance submissions to FDA
- Critically review submission documents and clinical trial documents such as clinical protocols, case report forms and informed consent documents to ensure compliance with regulatory requirements
- Provide input to study teams and assist with developing strategy by researching regulatory and medical information in preparing submissions to FDA
- Provide regulatory and operational support to investigators by interacting with project teams
- 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
- Other responsibilities may include but are not limited to: creating and revising SOPs and standard practice documents, development of tools, documents and resources for the purposes of creating standard practice, templates and education/training materials
- Demonstrates strong knowledge of the regulatory process and works toward process efficiency for all team members.
- Reviews manuscripts/posters presentations/abstracts as appropriate
- Demonstrates and ensures a high level of competency and compliance with University policies and Federal Regulations
- Responsible for the preparation and submission of expanded access requests for investigational drugs and devices
- Bachelor’s degree in a scientific or technical discipline
- 3-5 years’ experience in the medical device, pharmaceutical and/or regulatory field
- Organizational skills
- Problem solving skills
- Excellent interpersonal and communication skills
- Sophisticated medical terminology competence
- Demonstrated having worked positively in a team orientated atmosphere and managing a fast paced work environment
- Ability to successfully interact with diverse individuals, including: Principal Investigators, nurses, participants and families
- Excellent computer skills
- Expertise and experience with medical device regulations
- 2-5 years’ experience in the regulatory field, specifically in the submission of INDs and IDEs, or experience with filing an NDA, BLA, PMA or 510(k)
- Previous experience with the FDA Electronic Submission Gateway, including WebTrader and eCTD software and submissions.
This position is primarily remote, with occasional travel to Ann Arbor, MI required. Applicants from outside the local Ann Arbor area are encouraged to apply. Currently, all interviews are being conducted virtually.
Flexible work agreements are reviewed annually and are subject to change dependent on the business needs of the hiring department, throughout the course of employment.
Michigan Medicine values a culture of diversity, equity, and inclusion. We are committed to the development of a positive and inclusive environment.
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 anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
U-M COVID-19 Vaccination Policy
COVID-19 vaccinations are now required for all University of Michigan students, faculty and staff across all three campuses, including Michigan Medicine. This includes those working or learning remotely. More information on this policy is available on the Campus Blueprint website or the U-M Dearborn and U-M Flint websites.