At Memorial Sloan Kettering (MSK), we're not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we're driving excellence and improving outcomes. We're treating cancer, one patient at a time. Join us and make a difference every day.
In compliance with applicable New York and New Jersey State regulatory authorities, COVID-19 vaccination (2 doses of either the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine) is mandatory for all MSK employees, contingent workers, and volunteers. Exceptions are permitted for those employees who request and receive an approved medical or fully remote exemption.
*Staff working at a MSK New Jersey location must be up to date with COVID-19 vaccination, which includes having completed the primary COVID-19 vaccination series and booster once eligible as mandated by New Jersey State. All New Jersey staff not yet eligible for a booster must receive a booster within 3 weeks of becoming eligible as a condition of continued employment at MSK.
Note: Individuals are eligible to receive a COVID-19 booster five months after receiving the second dose of either the Pfizer or Moderna vaccine or two months after the J&J vaccine.
The Research and Technology Management Department is seeking a Regulatory Affairs Coordinator to join its dynamic and growing team. Join us today and help make a difference every day!
Assist in the daily activity of regulatory compliance at MSKCC, including and not limited to Investigational New Drug Applications, Investigational Device Exemptions, IND/Device Committee reviews and Biotechnology Collaborations.
Monitor federal regulatory requirements and assist in the implementation of these regulations with Investigators and research staff throughout the Institution.
Be responsible for the submission of all dossiers from MSK to the FDA in an eCTD format and ensure that MSK is compliant and adheres to eCTD specifications once criteria is established by the review division.
Manage the regulatory review process for the INDDC, including conducting detailed reviews of submissions.
Answer questions from our research staff and HRPP protocol submissions manager regarding submissions that will be processed for INDC review. Troubleshoot any issues as they arise.
Maintain all databases and portals within the IND Office and track trends as they relate to IND submissions or regulatory metrics.
Work on special educational projects (e.g. training manuals, newsletters, or didactic training program development) as needed.
A minimum of 2-4 year of experience in Clinical Research or a Regulatory environment.
Excellent communication skills both oral and written and the ability to interact and communicate with a diverse group of individuals.
A keen attention to detail.
This position will be primarily remote with 1-2 in-person days per month in New York City.
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. It's important to us that you have a sense of impact, community, and work/life balance to be and feel your best!
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.