Aufgaben

- Serve on early development and life cycle teams as the preclinical medical writer
- 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,
- Review, edit, and archive nonclinical study reports using an electronic document system
Support preparation and submission of preclinical publications

Qualifikationen

PhD degree in life sciences
Excellent written and spoken English including scientific terminology
At least 1 year of experience as medical writer or in a similar role (scientific editor, regulatory specialist, safety writer)
Ability to make own judgement about robustness of a scientific statement
- Ability to effectively communicate with other members of a cross-functional team
- Ability to prioritize tasks while working on multiple projects in parallel
- Sharp eye for detail
- Advanced knowledge of Microsoft Word (styles, cross-links, bookmarks, tracked changes, etc.)