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Senior Medical Writing Document Manager (Yacht Life Sciences)

Medical
Diemen

Description:

A multi-national pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments. Yacht Life Sciences has a vacancy for a Senior Medical Writing Document Manager Oncology. For the Medical Writing team of our client, we are looking for a Senior Medical Writing Document Manager Oncology who is located in Europe and is willing to work from home. The responsibilities of the Senior Medical Writing Document Manager Oncology may include, but ...

Requirements:

Education:

  • Requires an advanced degree in a scientific discipline or a bachelor’s degree with equivalent work experience. MSc or PhD in biological science is highly preferred
Experience:
  • Must have 8+ years project management and writing experience of high-quality clinical and regulatory documents within oncology
  • Must have experience with leading a team
  • Writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions is required
  • Pharmaceutical industry experience is required
  • Fluency in English (both oral and written)
  • Background in biologics is a plus
  • Experience with Immunology, Infectious Disease, CNS/Pain and/or Frontier Diseases is a plus
Special Skills:
  • Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details.
  • Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure.
  • Ability to critically analyze, synthesize, and communicate/present complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
  • Ability to adapt and work through conflicts to create consensus.
  • Proficiency in Microsoft Office applications.
  • Familiarity with CTD, ICH, GCP and other standards.
  • Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.
Address:

Europa