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In the absence of the QPPV and, as delegated, to take on the role and responsibilities of the QPPV, incl. acting as a single PV contact point for the competent authorities in the EEA and the UK on a 24‑hour basis; Support the QPPV in the compliant
You will play a crucial role in driving the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials studying TransCon C-type natriuretic peptide (CNP). This is an exciting opportunity to work in a fast-paced environment,
Responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsible for preparing and managing CMC regulatory
Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.). Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH,
Plays a role in establishing and maintaining partnerships with biopharma drug development translational and clinical biomarker teams. As such, this individual will participate in customer facing meetings to provide technical