CELL THER REGULATORY SPECIALIST II

At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America’s Best Large Employers and America’s Best Employers for Women, Computerworld magazine’s list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time’s Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet® designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999.
Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.

Summary

H. Lee Moffitt Cancer and Research Institute is a modern facility in Tampa, Florida.  We strive to be the leader in understanding in the complexity of cancer through team science and applying those insights for human benefits.  Be part of the cure by joining Moffitt's team of over 800 research faculty scientists, career staff scientists, postdocs, graduate students and support staff dedicated to cancer research.

Position Highlights:

• Opportunity to join a NCI designated comprehensive cancer center in production of novel cellular therapy treatments for cancer patients
• Participation in cutting edge adoptive cellular therapy treatments which include the culture and activation of immune cells to return to patients
• Involvement in the rapidly growing multiple clinical trials within the cell therapy area.

The Ideal Candidate

•  Experience and up-to-date knowledge of US regulatory procedures and changes
• Working knowledge of Adoptive Cell Therapy
• Understanding of good documentation practices and requirements
• The successful candidate will be a strong communicator, engaged, and will work closely with members of the Cell Therapy Team.
• Exhibit interest and excitement in participating in the production of cellular products.
• Values in teamwork and is comfortable leading complex projects in a fast-changing environment.

Responsibilities:

• Preparation of documentation and data required for regulatory documentation
• Processing and submitting information for reports for protocols
• Maintain working knowledge of regulatory guidance’s and resources associated with Cell Therapies
• Act as central contact for regulatory inquires
• Regulatory files creation and Maintenance.
• Comply with the facility's standard operating procedures and policies which incorporate the cGMP/cGTP, FACT, CAP and AABB regulatory standards applicable to cellular therapy product production and analysis.
• Other duties as assigned.

Credentials and Qualifications:

•  Associate degree with four or more years of experience in regulatory or clinical research. BS or MS preferred.
• Experience must be in biological life science or clinical research regulatory.
• Demonstrated competency in diverse biological processes following good documentation practices.
• Working knowledge of research regulatory topics and experience with document preparation relative to clinical trials.
• Ability to prioritize and pace oneself when working under the pressure of deadlines, and work volume.
• Knowledge of scientific and ethical Committee’s structures and functions.
• Demonstrated ability to work independently to achieve expected outcomes