Medical Writer - Mechelen, Leiden
Ref: MEC 278-279
This position can also be located in LEIDEN. Some travel will be required.
Galapagos is looking for an experienced Medical Writer. The ideal candidate has broad experience with the development and writing of different types of key documents, all in the end contributing to successful conduct and reporting of clinical trial results for a complete and concise submission dossier. The job requires:
- Coordinating, in the first place, our CRO partners with respect to their writing activities,
- Being the first point of contact for internal parties who seek to staff their requirements for writing activities.
- Defining and fine-tuning internal processes and standards
- Writing activities
- Participation in project- and study-teams and providing consultancy
- The successful candidate has at least an MSc degree in sciences, with at least 10 years of hands-on medical writing experience within the life-science / pharmaceutical industry used to writing of documents like informed consent forms, synopses, protocols, integrated and abbreviated study reports and investigator brochures.
- Furthermore you have profound understanding and working knowledge with respect to the preparation of documents for submission for marketing approval.
- You show proficiency with MS-Word and preferably with document management systems.
- You should be able to organize and plan multiple priorities, and have the ability to coordinate and collaborate with External Service Providers.
- Last but not least, having excellent interpersonal and communication skills is required, together with being fluent in English (oral and in writing).