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Medical Writer

- Mechelen

Job content

For a dynamic fast growing Biotech company we are looking for a Medical Writer. 

You will support the development and writing of clinical and regulatory documents. You will provide to the clinical team scientific and writing expertise, in order deliver timely documents that meet all quality and regulatory requirements.

  • Writing activities (clinical and regulatory documents)
  • Adequate planning of writing activities
  • Participation in project- and study-teams
  • Oversight of external medical writer(s), when a document is outsourced
  • The successful candidate has at least a MSc degree in sciences, with at least 3 years of hands-on medical writing experience within the life-science / pharmaceutical industry. Experience in writing pre-clinical text and/or pharmacokinetic/pharmacodynamics sections.
  • You are used to write documents like protocols, clinical study reports, briefing books, investigator brochures, and other regulatory documents (response to questions from authorities, pediatric investigation plan, …).
  • 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 

Aline Vandermeeren +32 16 30 95 09