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Serve on early development and life cycle teams as the preclinical medical writer to support development of individual compounds in a wide range of therapeutic areas;
Compile, edit, and manage review of preclinical sections of regulatory documents (IBs, briefing books, IND/NDA/MAA Modules 2.4, 2.6, 4) authored by cross-functional teams;
Perform quality control checks of the above documents to ensure accuracy, completeness, and scientific robustness of content, consistency of reported preclinical data, compliance with company style guides;
Review, edit, and archive nonclinical study reports using an electronic document system;
Support preparation and submission of preclinical publications.