Positionsnummer / Reference Number


Position / Job Title

Preclinical medical writer

Dauer / Project Length

12 months

Aufgaben / Tasks

- 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 / Qualifications

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.)

Weitere Informationen / Further Information

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