FDA Specialist

The FDA Specialist fills a critical compliance role at the University of Minnesota. As part of the Clinical and Translational Institute (CTSI), the FDA Specialist guides researchers across many therapeutic areas at the University of Minnesota according to FDA regulations, and ensures high-quality IND and IDE submissions are filed with the FDA. The FDA Specialist fills an important compliance role at the University of Minnesota by ensuring amendments and annual reports are filed on time, and sharing FDA updates back to the University of Minnesota research community.

This role is full-time, primarily remote.

Job Duties:
This position reports to the CTSI Regulatory Manager and works closely with regulatory staff in the Office of the Vice President for Research (OVPR).
35%: Annual Reports/ Amendments for Existing IND/IDE Submissions
* Ensure compliant completion and timely submission of FDA annual reports
* Oversee the process to compile needed information for annual reports and amendments
* Ensure FDA forms are accurately completed and submitted
* File documentation of receipt/ acknowledgement
* Assist study team with any follow-up communication from FDA
20%: Initial IND/IDE Submissions
* Oversee, guide, and route the IND/IDE submission process in compliance with federal regulations
* Critically review submission information, ensuring forms are accurate and finalized appropriately.
* File documentation of receipt/acknowledgement
* Assist study team with any follow-up communication from FDA and understanding study start dates
20%: IND/IDE Guidance to Study Teams
* Serve as a liaison to study teams for FDA requirements/determinations and submission process
* Serve as the point person to study teams on study design and quality/depth of background information required by the FDA
* Educate researchers on responsibilities of sponsor-investigator role
* Consult both in written formats and via face-to-face connections on FDA submissions
* Join study team meetings as needed to provide updates
* Independently resolve issues and escalate questions to OVPR consultants when required
* Strategize FDA pre-submission consultations
* Liaise with UMN drug, device and information technology experts in the areas of pre-clinical, pre-IND and QSub (device) FDA submissions.
* Collaborate with and understand other FDA support available across UMN
15%: Guidance on Part 11 Compliant Systems and Processes
* Serve as a Part 11 compliance subject matter expert regarding both signatures and data
* Utilize existing systems available at UMN and determine Part 11 compliance
* Assist in identifying additional Part 11 compliant data solutions for process improvement
10%: Other duties as assigned, including but not limited to:
* Seek to continuously improve processes related to this work
* Feasibility Reviews
* Attendance at, and knowledge sharing from, FDA-hosted webinars or meetings
* Develop and deliver trainings to UMN research community
* Analyze metrics and data for reporting, tracking, trends and improvements

Key terms: FDA, IND, IDE, regulatory, regulations, Part 11

All required qualifications must be documented in application materials.

Required Qualifications
* Bachelor's degree with 6 years relevant experience, or an advanced degree with 4 years relevant experience
* Prior experience with IND/IDE submissions to CDER, CBER, and CDRH

Preferred Qualifications
* Familiarity with both Common Technical Document (CTD) Format and Traditional Format for IND submissions
* Experience in an academic research setting
* Familiarity with UMN Policy Library
* Background in pharmacology
* Strong organizational skills and attention to detail
* Excellent communication skills
* Familiarity with research design and progression
* Expertise in Titles 21, 312, and 812 of the Code of Federal Regulations

The University of Minnesota Clinical and Translational Science Institute (CTSI) mission is to accelerate and improve clinical and translational science research, education and improve health. CTSI provides consultation, training, support, and services to researchers and research teams across the translational continuum. CTSI is part of the national, NIH-funded Clinical Translational Science Award (CTSA) program/consortium that works together to improve the efficiency, quality, and impact of clinical and translational research and science.

Working at the University

At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University also offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF)
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

Please visit the for more information regarding benefits.

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-UOHR (8647).

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.