Manager Research Regulatory Affairs

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Manager of Regulatory Affairs you will oversee all aspects of the regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department. You will be responsible for developing and implementing short and long term strategies for the regulatory compliance for the site Clinical Operations. You will ensure Sarah Cannon adheres to and maintains Food and Drug Administration (FDA) regulatory compliance as well as oversees any regulatory audit. You will work closely with the department directors and/or primary investigators, industry sponsors and other outsides entities.  You will manage, directs, plan and schedule activities and programs for the regulatory department  You will establish and enforce procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, standard operating procedures (SOPs), and other applicable guidelines  You will develop and implement regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sites  You will manage the regulatory affairs between the organization for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines; for individual sites, studies, sponsors and/or other networks  You will manage the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors  You will resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies  You will develop and implement an approved archiving system for study specific regulatory documentation and correspondence  You will apprise management of important regulatory issues and obtains guidance when necessary  You will attend network meetings, conference calls and monthly staff meetings as appropriate  You will visit strategic sites and provides training and mentoring as needed  You will provide proactive and creative recommendations on how to meet goals and handle identified deviations  You will be responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists  You will be responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issues  You will initiates improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects  You should have for this position: A Bachelor’s Degree  Knowledge of scientific and clinical research terminology  Knowledge of FDA and GCP guidelines  Knowledge of organizational policies, procedures, and systems.  At least three years of experience in regulatory affairs  At least on year of experience in a supervisory role  About Sarah