Sr. Research Regulatory Affairs Manager - VICTR

Requisition Number 1901916

Your Role

In your pivotal role, you will serve as the central resource to investigators to assist and provide guidance regarding Investigational New Drug (IND) development through experience with and knowledge of related federal regulations (FDA). You will work closely and partner with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures and federal regulations. You will provide quality assurance support with focus on compliance with methods, facilities and controls as they relate to federal regulations. In this role you will serve as a resource to investigators to assist and provide guidance and education regarding device development through experience with and knowledge of related federal regulations.

Bachelor's Degree (or equivalent experience) and 8 years relevant experience required!

Position Qualifications

• PhD preferred
• 3-4 years' experience working in clinical drug trial research
• 1 year experience working with the IND

• Strong project planning, strategy, leadership, negotiation and presentation skills as well as an ability to contribute creatively and practically to resolve problems and capitalize on opportunities.
• Experience in developing an IND strategy and amendments
• Ability to standardize consulting practices across multiple regions in order to streamline efficiencies and improve overall delivery of service while maintaining the highest standards in regulatory compliance.
• Ability to establish and maintain relationships with sponsoring companies, investigators and institutional research units to optimize the performance of research activities while managing the activities of investigative sites across multiple protocols and multiple areas.
  

Click Here To View The VUMC Promise of Discovery

Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments.

• US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology (Bill Wilkerson Center), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
• Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
• Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
• The Leapfrog Group: grade "A" in Hospital Safety Score
• National Institutes of Health: among the top 10 grant awardees for medical research in the US
• Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
• Nashville Business Journal: Middle Tennessee's healthiest employer
• American Hospital Association: among the 100 "Most Wired" medical systems in the US