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You will be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
Define and lead the execution of global regulatory CMC strategies for device & combination products to ensure successful approvals in key markets and Compliance throughout development and lifecycle. Performs risk analysis for determination of probability
Responsible for overseeing clinical operations deliverables across countries and sites, ensuring high-quality study execution in compliance with ICH GCP, SOPs, and protocol requirements. You will act as a key operational lead within the project team,
Define medical strategy in line with company ambition and cluster scorecard/priorities. Assess, design, and lead all medical activities including research programs, clinical trials, RWE programs, data mining projects, and all data generation activities.
Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required. Accountable for comprehensive site management activities to ensure timely delivery of enrolment