| Company Overview:|
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 27th 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 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.
The Regulatory Compliance Coordinator manages the operational processes and functions of the MSKCC Investigational New Drug and Device Office. Acts as the primary liaison between the IND and HRPP Office’s and clinical departments for the review of MSK sponsored IND clinical protocols. Provides coverage and support to the Regulatory Compliance Manager and Sr. Compliance Coordinator for all regulatory and operational activities of the IND Office. The Regulatory Compliance Coordinator will assist with the electronic submission process for all eINDs to the FDA, along with pre-reviewing and submitting all dossiers to the agency. Responsible for maintaining all IND files and will work in conjunction with the information systems unit to support MSK efforts to digitize our IND portfolio. Assist MSK investigators with the annual NCI Investigator Registration process.
Responsibilities include the following:
- Research Regulatory Compliance Management
- Electronic Common Technical Document Submissions (eCTD)
- Investigational Drug and Device Committee (INDDC) Regulatory Reviewer
- Investigational New Drug/Device Portal and Databases
- Training and Education Program Development
- Special Projects
- Bachelor’s degree with 2-4 years of clinical research experience.
- Relevant graduate work would be considered in lieu of minimum experience.
- Demonstrated written communication skills - This position requires the ability to apply a broad range of technical and specialized knowledge and significant job-related experience to handle complex work assignments.
- Strong verbal communication and listening skills.
- Articulate and responsive to colleagues - This position requires strong communication skills both oral and written and the ability to interact and communicate with a diverse group of individuals.
- Ability to build strong customer relationships - Administrative skills required include prioritization, project management, operational oversight, and planning/organizing meetings.
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.
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