WI3664890

1

Master's Degree

PhD

Unspecified

40

JOB REQUIREMENTS: 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:
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: 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:\...
For full info follow application link. 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/
\*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/2860780EE5B443C8