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Senior Specialist, Controlled Substances

Equipment/Technology Specialist

Equipment and Facilities Specialist


Cambridge, Massachusetts, United States

Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients<br><br>Purpose:<br>This Senior Specialist for Controlled Substances is responsible for maintaining the controlled substances program, policies, and procedures for NIBR Cambridge under the guidance of the Head, ICM Controlled substance program. The Senior Specialist, Controlled Substances is responsible for providing technical, day-to-day support and training to researchers who handle controlled substances and monitoring their compliance with the Controlled Substances program.<br><br>Major Accountabilities: <br>• Serves as the point of contact with US researchers on matters involving controlled substances and prescription items<br>• Manages controlled substances and prescription items requests from researchers.<br>• Assists researchers in determining their needs (e.g. drugs, questions with formulations, new license requirements DEA and MDPH, ordering, receiving, disposing) and resolves any issues in the US related to controlled substance materials<br>• Performs periodic inspections of laboratory spaces using controlled substances and assists with disposal of controlled substances.<br>• Maintains a controlled substances inventory for NIBR CA; develops and provides monthly performance measures and statistics; conducts audit checks of the controlled substances program and assesses for continuous process improvements<br>• Assists researchers in the US with unannounced DEA controlled substances inspections.<br>• Meets all reporting requirements of the DEA.<br>• Conducts training sessions with employees responsible for direct handling of controlled substances in order to ensure their understanding of DEA requirements. <br>• Participate in the development of internal procedures pertinent to the handling of controlled substances in order to ensure compliance with Company requirements as well as local, state and federal regulations and laws<br>• Record and document processes related to Controlled substances and prescription items to allow process analysis and optimization<br>• Report Non compliances, incidents and manages CAPA according to the program rules under supervision.<br>• Participate in the maintenance of the CS program Risk evaluation and may be involved in mitigation actions<br>• Interacts as needed with NBS Security regarding screening review of all areas in which controlled substances are handled or transported to minimize the opportunity for hiding places; scrutinize and adjust as needed camera placement; creates sound designated observer programs in order to minimize the risk of diversion<br><br>The pay range for this position at commencement of employment is expected to be between $88,0000 and $132,000/year; however, while salary ranges are effective from 1/1/22 through 12/31/22, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.[#video#{#400,300#}#/video#]