Idorsia Basel Switzerland
1 month ago
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 Idorsia style guides etc. Review, edit, and archive nonclinical study reports using an electronic document system (Veeva Vault) Support preparation and submission of preclinical publications
PhD degree in life sciences Excellent written and spoken English including scientific terminology At least 2-3 years of experience as medical writer Ability to make own judgement about robustness of a scientific statement and whether it is... supported by the available data Ability to effectively communicate with other members of a cross-functional team (e.g., preclinical and clinical researchers, regulatory specialists, project managers) on a daily basis Ability to prioritize tasks while working on multiple projects in parallel Ability to provide high-quality medical writing support with minimal supervision Sharp eye for detail Advanced knowledge of Microsoft Word (styles, cross-links, bookmarks, tracked changes, etc.)
The position is office based with home office flexibility for Swiss residents
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