Job Title:   Manager, Regulatory
Pay Grade:   8
Pay Band Min / Max:    - 
 
Position Number:   034932
Department / Hospital:   STEM CELL INSTITUTE

The University of Miami Miller School of Medicine-UHealth is home to some of the brightest minds in the world. Our Faculty teach students who represent the future of medicine. Our researchers are discovering breakthrough patient treatments. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and subspecialties, and have more than one million patient encounters each year.
 


The Department of Stem Cell Institute is seeking a Regulatory Compliance Manager who under the guidance of the Director of the Experimental and Clinical Cell-Based Therapies Program, will be responsible for ensuring that submitted research is reviewed efficiently and is consistent with regulations. Responsible for the accurate and timely processing, tracking and filing of submission to and actions by the IRB. Obtains and distributes required information for Chairman or IRB review, maintaining files and prepares and distributes minutes as per federal guidelines. Maintain accurate records of IRB actions, documenting communication with Principle Investigators, regulatory entities and any other parties involved. Develop, implement and oversee regulatory compliance strategies of the ISCI inclusive of monitoring and auditing clinical trials. Initiate development of standard operating procedures for monitoring and auditing of clinical trials. Ensure trials are consistent with proposals approved by the Institutional Review Board, and in compliance with applicable federal and state laws, statutes and regulations. Responsible for generating, submitting and following up on Investigational New Drugs (INDís)submissions, Series Adverse Effects (SAEís), etc. Interface and serve as liaison with regulatory agencies. Review proposed changes to submissions and advise whether the changes requires regulatory approval. Respond to regulatory agencies to address questions or deficiencies in submissions. Maintain regulatory agency correspondence files.


Minimum qualifications include a Bachelorís Degree plus three years of work related experience. Masterís degree preferred. Three years of experience in preparing submissions and working with the FDA and other regulatory agencies preferred. Must have the ability to read, analyze, and interpret governmental regulations and laws, periodicals, professional journals, or technical procedures. Detail oriented person with strong analytical organizational and communication (both verbal and written) required. Clinical trials experience in either industry or hospital environment is preferred. Able to communicate effectively with regulatory agents, inspectors and representatives of regulatory agencies. Must be a team player, ability to manage multiple tasks simultaneously and to achieve results in a timely and accurate manner. Working knowledge of current software/systems available (i.e., Microsoft Word, Excel and email systems) and ability to learn new software, technology and equipment quickly and efficiently. Must have the ability to handle sensitive and confidential information appropriately. Any appropriate combination of education, certifications, and/or relevant work experience will be considered.



UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. University of Miami Hospital is the flagship facility of UHealth, which also includes the Sylvester Comprehensive Cancer Center and Bascom Palmer Eye Institute, along with dozens of outpatient facilities. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.



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