Medical Writer Lead

hace 3 horas


Madrid, Madrid, España Pharmiweb A tiempo completo
Principal Medical Writer

As a key member of our team, you will be responsible for leading the development of clinical submission documents and driving the content strategy for assigned drug projects.

Key Responsibilities:

  • Develop and implement the content strategy for clinical submission documents, working closely with cross-functional teams.
  • Lead the planning, development, and implementation of clinical submission documents, ensuring compliance with regulatory agency guidelines.
  • Collaborate with writers and other submission team experts to develop and implement the submission authoring strategy for all clinical documents.
  • Maintain current knowledge on regulatory agency medical review guidelines and drug approval requirements for assigned projects.
  • Develop and implement authoring resource plans for all clinical submission documents of assigned drug projects.

Requirements:

  • 5-6 years of experience in regulatory medical writing, with 4 years of experience in writing submission documents.
  • 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.
  • Master's degree in natural sciences; strong candidates with a Bachelor's degree will also be considered.

Why ICON?

We offer a comprehensive and competitive total reward package, including a wide range of variable pay and recognition programs, best-in-class employee benefits, and supportive policies and wellbeing initiatives.

Our success depends on the knowledge, capabilities, and quality of our people, and we are committed to developing our employees in a continuous learning culture.

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.


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