Precision Medicine & Digital Health - Regulatory Affairs Specialist studioChester, Uxbridge or MoretonMust have list:1. In vitro diagnostics regulations in precision medicine under US and EU regulations2. Worked on drug trials that use a biomarker to select patients into the trial, include but not limited to, understand clinical trial assay (CTA) requirements with diagnostic partners, sample testing/shipping regulations in different countries, and CDx development requirements3. Has built a diagnostic device regulatory strategy plan for a biomarker-driven trial4. Kept up to date on Digital Health technology regulatory requirements and worked on a digital pathology or digital health product in a drug trial RolePrecision Medicine & Digital HealthLocationUKRateGBP 60 to 70Work ModeRemoteDuration6 monthsIR 35Inside IR 35Key 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.
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