Are you interested in gaining more exposure to Investigational New Drugs? Are you passionate about clinical research?
We are seeking a Regulatory Compliance Coordinator to join the Regulatory Oversight & Product Development team. Our team is the liaison between MSK and government agencies responsible for the investigational use of drugs, devices and biologics and monitors all applicable regulations to ensure institutional adherence.In this role, you will manage the operational processes and functions of the MSKCC Investigational New Drug and Device Office.
Act as the primary liaison between the IND and HRPP Offices and clinical departments for the review of MSK sponsored IND clinical protocols.
Provide coverage and support to the Regulatory Compliance Manager for all regulatory and operational activities of the IND Office.
Assist with IND Applications and IND Committee reviews
Oversee the electronic submission process for all eINDs to the FDA, along with pre-reviewing and submitting all dossiers to the agency.
Maintain all IND files and will work in conjunction with the information systems unit to lead MSK efforts to digitize our IND portfolio.
Submit and manage Emergency Single Patient Use applications with the FDA and coordinates FDA comments and Investigators responses back to the FDA.
Provide information and support to our biotechnology collaborators as directed.
Monitor federal regulatory requirements and assists the Regulatory Compliance Manager in the implementation of these regulations with Investigators and research staff throughout the Institution.
An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.
Adept at planning and prioritizing work to meet commitments aligned with organizational goals.
A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
Able to operate effectively, even when things are not clear or the way forward is not obvious.
Bachelors degree with 2-4 years of clinical research experience, preferably in regulatory.
Prior knowledge of IND/NDA is helpful
Familiarity with clinical research and IRB
Oncology research experience preferred.
Internal Number: 2019-33524
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.