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Accountable for assessing, establishing and operationalizing the regulatory strategy and execution plan for assigned IVD performance studies and for clinical trials that use IVDs, ensuring that study conduct and IVD use are compliant with the EU IVDR
The role assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site/Global QMS GMP policies and procedures. Additional responsibilities will ensure departmental
Your tasks include project management of interdisciplinary teams (leadership, team building, goal achievement) tasked with Chemical R&D and Manufacturing activities. Structuring and coordinating project specific activities including risk and time
Support the Medical Information function at Idorsia and provide product specific expertise. Additionally, this role contributes to various Medical Information projects and processes such as content generation, enquiry escalation handling, metric reports,
In this senior leadership role, you will lead an interdisciplinary Analytical Development team responsible for the implementation, development, optimization, and validation of analytical methods for small‑molecule products in a GMP‑regulated