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Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader; Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process; Assures and exerts
Lead, manage and mentor the team on the synthesis of safety data from multiple sources (e.g., clinical trials, postmarking data, literature, cumulative analyses) to support meaningful discussion during SDRs; Contextualize emerging safety trends by
Lead and inspire the Clinical Field Excellence team (direct reports) as well as influence global field teams, fostering a culture of innovation and continuous improvement to achieve industry-leading standards and results. Develop and implement high-impact
The role will provide scientific and technical leadership for analytical development at various stages of drug development both internal and external through CDMO with particular emphasis on research and early development (pre-DP0) including material
Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements. Under general supervision, implement product related