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Senior/Principal Medical Writer Specialist

1 week ago

Copenhagen, Copenhagen, Denmark Pharma IT Full time
About the Role

We are looking for a Senior/Principal Medical Writer Consultant with a strong background in medical writing and clinical development to join our team.

The ideal candidate will have at least 10 years of experience within drug development in the pharma/biotech industry, with a minimum of 5 years of experience in medical writing.

Main Qualifications:

  • Understanding of international regulations, ICH guidelines, and document preparation and production (CTDs).
  • Knowledge of clinical development, including phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
  • Excellent interpersonal skills, with the ability to collaborate effectively with multidisciplinary teams.
  • Exceptional problem-solving and decision-making abilities, with a focus on achieving results.
  • Excellent written and verbal communication skills in English, with the ability to present complex information to diverse audiences.