Medical Writer Expert

hace 4 semanas


Madrid, Madrid, España Pharmiweb A tiempo completo

Job Summary

We are seeking a highly skilled Medical Writer Expert to join our team at Pharmiweb. As a key member of our medical writing team, you will be responsible for developing high-quality clinical submission documents in support of regulatory submissions globally.

Key Responsibilities

  • Develop and implement content strategies for clinical submission documents, including Safety Summaries, Efficacy Summaries, and Clinical Overviews.
  • Lead cross-functional writing teams to develop and implement authoring resource plans for clinical submission documents.
  • Maintain current knowledge on regulatory agency medical review guidelines and drug approval requirements.
  • Collaborate with subject matter experts to develop and implement clinical data presentation strategies and messaging standards.

Requirements

  • 5-6 years of experience in regulatory medical writing, with 4 years of experience in writing submission documents.
  • Master's degree in natural sciences, or Bachelor's degree with strong relevant experience.
  • Strong understanding of the overall drug development process, including clinical study report development, regulatory and drug safety requirements, and clinical data management and statistical processes.

Why Pharmiweb?

We offer a comprehensive and competitive total reward package, including excellent base pay, variable pay, and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career.


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