Posizione: Mid-Senior level

Tipo di lavoro: Full-time

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Contenuto del lavoro

  • You prepare complex documents such as integrated CTD summaries and IBs, ensuring adherence to regulatory requirements and internal standards
  • You ensure the availability of high-quality SEND datasets as required by regulatory agencies
  • You serve as an expert in using authoring tools and ensure compliance with our client writing styles and regulatory specifications
  • You maintain Nonclinical Medical Writing trackers supported by a network of internal and external partners
  • You proactively identify opportunities for process improvements to enhance compliance and efficiency in submissions

What are we looking for?

  • You hold a PhD, MSc, or BSc in a relevant pharmaceutical development science
  • You have over 5 years of experience in a similar role, with a strong awareness of nonclinical study regulatory requirements
  • You are proficient in standard software (MS Office), and authoring tools (ideally StartingPoint and PleaseReview)
  • You are an excellent communicator with strong written and verbal skills
  • You have a thorough understanding of Good Laboratory Practices (GLPs), ICH guidelines, and SEND requirements
  • You are fluent in English
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Scadenza: 06-01-2026

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