Memorial Sloan-Kettering Cancer Center Regulatory Compliance Manager - Investigational New Drug Office in New York, New York
Regulatory Compliance Manager – Investigational New Drug Office
Job Posting Number: 21759
Professional – Research Administration
April 25, 2018
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.
In adherence to the institutional standards and federal regulatory requirements set forth by the FDA, NIH and OHRP regarding investigational drugs, devices, and biologics, the Regulatory Compliance Manager provides guidance and information to MSKCC Investigators and clinical research staff. Acts as the primary liaison between MSK and applicable government agencies responsible for the investigational use of drugs, devices and biologics and monitors all applicable regulations to ensure institutional adherence. Directs the daily operations and regulatory compliance of the Center’s Investigational New Drug Office.
Responsibilities include the following:
IND/IDE Office Operations and Staff Management
FDA Liaison for MSKCC Sponsored Clinical Trials
Multicenter (MCT) Investigational New Drug Management
Investigational Drug and Device Committee (INDDC) Reviewer
Research Regulatory Compliance
Investigational New Drug/Device Portal and Databases
Training and Education Program Development
Investigational New Drug Cost Recovery/ Orphan Drug Designations/ Pre-IND Meetings
Bachelor’s degree (Master’s preferred)with 4-7 years of clinical research experience.
2-4 years of supervisory and managerial experience.
Oncology research experience preferred.
Regulatory experience strongly preferred.
Understanding of drug development regulatory strategy, strongly preferred.
Knowledge of licensing agreements in relation to regulatory deliverables, strongly preferred.
Experience in filing for FDA expedited programs, strongly preferred.
Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of the Center. Responsible for writing, preparing, and educating staff on procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses etc), administration, research and clerical support staff, and institutional leaders. Excellent oral and written communication skills are required.
Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff at MSKCC as well as appropriate external contacts.
Analytical 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. A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Requires excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey this information in a timely and proficient manner.
Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established timeframes and deadlines.
Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSKCC is essential.
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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