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Associate Director, Global Regulatory Sciences, Precision Medicine
7 months ago
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Position Responsibilities
Degree / Experience Requirements
Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experienceKey Competencies
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development. Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives. Experience with clinical trial assays (CTA) in drug clinical trials in communicating between Diagnostic sponsor and Drug sponsor. Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions. Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies. Ability to apply project management techniques within teams and effectively manage meetings. Demonstrated ability to breakdown complex, scientific content into logical components. Ability to coordinate global activities, facilitate issue resolution and conflict management. Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks. Demonstrated ability to negotiate with and influence others. Understanding of strategic and tactical role for the drug development process. Understanding of general global regulatory requirements for drugs in development. Understanding of R&D process and specific regulatory responsibilities/deliverables for the company decision points.