Waterloo, BELGIQUE
2 dagen geleden

détail de l'offre

Entreprise : Keyrus Biopharma, member of the international group Keyrus, is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early-

to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.

Poste et missions :

Being an active member of the Medical and Scientific Communication Department, your main duties are :

  • Synthesize literature review findings into reports in various therapeutic areas.
  • Write, edit and update clinical documents with the highest level of technical accuracy (clinical protocols, informed consent form, study reports, investigator brochures, clinical trial results, annual reports, statistical analysis plans, briefing documents, pediatric investigational plans and others clinical documents).
  • Lead the process of critical review of scientific documents and incorporate multiple reviews into successive drafts. Provide QC support for clinical documents as needed.
  • Ensure the quality of clinical documents by maintaining and promoting familiarity with ICH, GCP, and other standards.
  • Liaise with authors and clients regarding scientific content.
  • Write, review and edit manuscripts and abstract.
  • Attend internal and external team meetings.
  • Provide support for others activities in the department (medical communication and information).
  • Profil :

  • Life sciences degree (preferably Phd in Biology or Pharmacy).
  • Excellent level of spoken and written French and English.
  • Previous experience in Medical Writing or Clinical Research is a plus.
  • Proficient in computer operations and MS Office tools (Word, Excel, PowerPoint).
  • Team Player.
  • Strong organization skills.
  • Excellent communication skills.
  • Stress resistant.
  • Ability to deal with complex scientific issues.
  • Flexible.
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