Medical Writer Lead

hace 3 semanas


Las Palmas de Gran Canaria, Las Palmas, España Pharmiweb A tiempo completo
Principal Medical Writer

As a key member of our team, you will be responsible for leading the development of high-quality clinical submission documents. Your expertise in medical writing will be instrumental in driving the content strategy for assigned drug projects.

Key Responsibilities:

  • Develop and implement content strategies for clinical submission documents
  • Lead the planning, development, and implementation of clinical submission documents
  • Collaborate with cross-functional teams to develop and implement authoring resource plans
  • Maintain current knowledge on regulatory agency medical review guidelines and drug approval requirements
  • Develop regulatory submission content strategy and lead cross-functional writing teams

Requirements:

  • 5-6 years of experience in regulatory medical writing, with 4 years in writing submission documents
  • Master's degree in natural sciences, or Bachelor's degree with strong candidates also considered
  • Thorough understanding of the overall drug development process
  • Specific knowledge of clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions

Why ICON?

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.

We are committed to developing our employees in a continuous learning culture, where every experience adds to your professional development. ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.


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