What are the responsibilities and job description for the Regulatory Specialist Intermediate position at Michigan Medicine?
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.
Job Summary
The Medical School Office of Regulatory Affairs is seeking a highly responsible and skilled Regulatory Specialist Intermediate to join its Conflict of Interest (COI) team. This position will report to the Regulatory Affairs Associate Director for Conflict of Interest.
Responsibilities*
Key responsibilities include, but are not limited to, the following:
Intermediate Level Required Qualifications
Bachelor's degree with 1-4 years of responsible regulatory, administrative, or research-related experience. Demonstrated interpersonal skills and an ability to interact with a wide variety of individuals with poise, patience, and respect. Excellent communication skills, including the ability to compose professional correspondence. Strong organizational skills, including the ability to multitask, manage competing priorities, and pay attention to detail. Proven ability to use discretion and appropriate judgment regarding sensitive and confidential matters. Must be able to work both independently and within a team setting, employ a customer service approach to all interactions, be self-directed, operate with limited direct supervision, and be willing to learn and take on new responsibilities. Must be proficient with Microsoft Word, Excel, PowerPoint, Google Drive, and commonly used administrative systems.
Associate Level Required Qualifications
Bachelor's degree with 1-3 years of responsible administrative experience. Demonstrated interpersonal skills and an ability to interact with a wide variety of individuals with poise, patience, and respect. Excellent communication skills, including the ability to compose professional correspondence. Strong organizational skills, including the ability to multitask, manage competing priorities, and pay attention to detail. Proven ability to use discretion and appropriate judgment regarding sensitive and confidential matters. Must be able to work both independently and within a team setting, employ a customer service approach to all interactions, be self-directed, operate with limited direct supervision, and be willing to learn and take on new responsibilities. Must be proficient with Microsoft Word, Excel, PowerPoint, Google Drive, and commonly used administrative systems.
Desired Qualifications*
Advanced degree with 3-5 years of progressively responsible regulatory and administrative experience and a high degree of initiative. Familiarity with federal regulations, policies, and guidelines related to the conduct of research. Familiarity with University and Medical School policies, procedures, and systems, including research and other oversight units (e.g., IRB, IACUC, ORSP, Innovation Partnerships, M-Inform, eResearch). Interest and ability to understand and apply professional and ethical standards and regulatory requirements.
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?
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.
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 employment opportunity employer.
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.
Job Summary
The Medical School Office of Regulatory Affairs is seeking a highly responsible and skilled Regulatory Specialist Intermediate to join its Conflict of Interest (COI) team. This position will report to the Regulatory Affairs Associate Director for Conflict of Interest.
Responsibilities*
Key responsibilities include, but are not limited to, the following:
- Independently conduct routine conflict of interest reviews to ensure university and faculty member compliance with federal and state regulations, and university/U-M Medical School policies, procedures, and guidelines.
- Prepare routine conflict management plans for faculty involved in external activities that create (in actuality or appearance) a conflict of interest with their university-related efforts.
- Conduct annual reviews of established conflict management plans.
- Conduct annual reviews of Public Health Service-funded research projects for potential changes to research investigators? conflicts of interest.
- Review outside interest disclosures for compliance with institutional policies, including reconciling differences between those disclosures and publicly available data.
- Provide proactive and comprehensive staff support for committee membership, including roster maintenance and term-tracking, appointments, on/off-boarding, and associated correspondence and records.
- Provide proactive, comprehensive staff support for meetings, including annual and ad hoc scheduling, agendas, reminders to participants, minutes, follow-up actions, and associated correspondence and records.
- Track departmental compliance with outside interest disclosure and reviews, sending reminders as needed.
- Respond to conflict of interest-related inquiries from faculty, staff, trainees, Medical School departments, and other units.
- Assist in monitoring the conflict of interest program, including the production of metrics
- Assist in preparing reports, presentations, and educational materials
- Maintain records, procedure manuals, and website content
- Prepare reports, presentations, and educational materials
- Participate in process and system improvement collaborations with other stakeholder units, such as the UM Office of Research (OVPR), the Office of Research and Sponsored Projects (ORSP), Innovation Partnerships (IP), Michigan Medicine Corporate Compliance (MMCC), and Information and Technology Services (ITS), among others.
- Provide other administrative support as needed.
- Assist the Associate Director for COI in all team activities, including review of COI policies and processes.
- Perform other duties and special projects, as assigned.
Intermediate Level Required Qualifications
Bachelor's degree with 1-4 years of responsible regulatory, administrative, or research-related experience. Demonstrated interpersonal skills and an ability to interact with a wide variety of individuals with poise, patience, and respect. Excellent communication skills, including the ability to compose professional correspondence. Strong organizational skills, including the ability to multitask, manage competing priorities, and pay attention to detail. Proven ability to use discretion and appropriate judgment regarding sensitive and confidential matters. Must be able to work both independently and within a team setting, employ a customer service approach to all interactions, be self-directed, operate with limited direct supervision, and be willing to learn and take on new responsibilities. Must be proficient with Microsoft Word, Excel, PowerPoint, Google Drive, and commonly used administrative systems.
Associate Level Required Qualifications
Bachelor's degree with 1-3 years of responsible administrative experience. Demonstrated interpersonal skills and an ability to interact with a wide variety of individuals with poise, patience, and respect. Excellent communication skills, including the ability to compose professional correspondence. Strong organizational skills, including the ability to multitask, manage competing priorities, and pay attention to detail. Proven ability to use discretion and appropriate judgment regarding sensitive and confidential matters. Must be able to work both independently and within a team setting, employ a customer service approach to all interactions, be self-directed, operate with limited direct supervision, and be willing to learn and take on new responsibilities. Must be proficient with Microsoft Word, Excel, PowerPoint, Google Drive, and commonly used administrative systems.
Desired Qualifications*
Advanced degree with 3-5 years of progressively responsible regulatory and administrative experience and a high degree of initiative. Familiarity with federal regulations, policies, and guidelines related to the conduct of research. Familiarity with University and Medical School policies, procedures, and systems, including research and other oversight units (e.g., IRB, IACUC, ORSP, Innovation Partnerships, M-Inform, eResearch). Interest and ability to understand and apply professional and ethical standards and regulatory requirements.
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
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.
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 employment opportunity employer.