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 State regulatory authorities, COVID-19 vaccination is mandatory for all MSK staff. Staff are considered fully vaccinated upon completion of a primary vaccination series for COVID-19 (i.e., one dose of a single dose vaccine or a final dose of a multi-dose vaccine series). Exceptions from the COVID-19 vaccine requirement are permitted for those who request and receive an approved medical or fully remote exemption. Requests for medical exemption can take up to two weeks to review. Vaccination or an approved medical exemption is required to start work.
*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 two months after completion of a primary vaccination series for COVID-19. Because vaccine-induced immunity can wane over time, MSK continues to strongly urge all staff to get a COVID-19 booster as soon as they become eligible to maintain their protective immunity for a longer period.
Are you seeking an opportunity to be at the forefront of innovation during this exciting time at Memorial Sloan Kettering Cancer Center? As the world's oldest and largest private cancer center, absolutely everything that we do is focused on changing the way that the world treats cancer. Research is integral to our mission at MSK and clinical trials help us discover better forms of patient care and treatment. Our outstanding scientists and clinicians work together to drive intake on and take on some of the greatest challenges of biomedical science.
The Research and Technology Management Department is looking for 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 participate 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.
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 supervise 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 years of experience in Clinical Research or a Regulatory environment.
Excellent oral and written communication skills and the ability to interact and connect with a diverse group of individuals.
Keen attention to detail.
This position will be primarily remote with 1-2 in-person days per month in New York City.
Competitive compensation packages | Sick Time |Generous Vacation+ 12 holidays to recharge & refuel| Internal Career Mobility & Performance Consulting | Medical, Dental, Vision, FSA & Dependent Care|403b Retirement Savings Plan Match|Tuition Reimbursement |Parental Leave & Adoption Assistance |Commuter Spending Account |Fitness Discounts &Wellness Program | Resource Networks| Life Insurance & Disability
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. It's meaningful to us that you have a sense of impact, community, and work/life balance to be and feel your best!
Our Hiring Process
You review the posting, agree it sounds like a phenomenal fit & apply. If your profile aligns, our Talent Acquisition team will contact you to schedule a phone interview. After speaking with the Talent Acquisition Specialist, you will connect with the Hiring Manager by phone or video. If the position is a fit, our team will perform reference checks, make an offer, and discuss onboarding and orientation.
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.