Regulatory Scientist

Job Summary

The successful applicant will be part of the University of Wisconsin-Madison's Program for Advance Cell Therapy (PACT) multidisciplinary team led by Associate Dean Jacques Galipeau and focused on deployment of cell and gene therapy first-in-human and early phase clinical trials in partnership with UW Health clinical translational research professionals. The candidate will lead and manage FDA CBER IND & IDE application preparation and submission; IND & IDE maintenance including reports and amendments using Florence Healthcare eBinders; preparation for internal and external compliance reviews of FDA related regulatory documents; and assisting IND/IDE Study UW clinical Principal Investigators with protocol development for compliance with the Code of Federal Regulations.

Responsibilities: Scientist III (RE045)

Scientist II (RE044) Tasks:

Disseminates information for appropriate entities, including the FDA.Synthesize research data for IND/IDE submissions and reports.

Institutional Statement on Diversity

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Education

Required

Terminal Degree

PhD in Biological or Clinical Sciences required, or other closely related field.

Qualifications

Experience writing FDA IND and IDE components including clinical trial, non-clinical data or CMC required. Communications experience with IRB or other regulatory units preferred. General experience in GMP pharmaceutical process development, manufacturing, Quality Assurance, Quality Control analytics, and grant/business plan writing are encouraged.

Work Type

Full Time: 100%

This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration

Ongoing/Renewable

Salary

Minimum $65,000 ANNUAL (12 months)

Depending On Qualifications

The anticipated minimum starting salary for the position is $65,000 as Scientist II and $85,000 as Scientist III. Starting salary is negotiable based on experience and qualifications.

Additional Information

The selected applicant will be responsible for ensuring their continuous eligibility for employment in the United States on or before the effective date of the appointment. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants.

Applicants for this position will be considered for the titles listed in this posting. The title is determined by the experience and qualifications of the finalist.

How to Apply

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.

Contact

Charles Amble

caamble@medicine.wisc.edu

608-262-5609

Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title

Scientist II(RE044) or Scientist III(RE045)

Department(s):

A53-MEDICAL SCHOOL/MEDICINE/HEM-ONC

Employment Class

Academic Staff-Renewable

Job Number

296326-AS

The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence through diversity and encourage all qualified individuals to apply.

If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/

Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department .