Clinical Evaluation Report Specialist

7 days ago


Sheffield, Sheffield, United Kingdom Publicis Groupe UK Full time
Job Description:

We are seeking a highly skilled medical writer to join our team at Publicis Groupe UK. As a Clinical Evaluation Report Specialist, you will be responsible for translating complex scientific and clinical information into clear and concise documents.

Key Responsibilities:

  • Prepare and edit clinical study protocols, clinical study reports, investigator brochures, and other regulatory documents for submission to health authorities.
  • Ensure that these documents comply with regulatory guidelines and standards.
  • Contribute to the development of manuscripts, abstracts, and posters for publication in scientific journals and presentations at conferences.
  • Communicate complex scientific and medical information in a clear and understandable manner for diverse audiences, including healthcare professionals, patients, and the general public.
  • Prepare safety-related documents such as periodic safety update reports (PSURs), risk management plans, and other safety documents required for regulatory submissions.
  • Collaborate with cross-functional teams to compile and write sections of regulatory submissions, such as New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and Investigational New Drug (IND) applications.

Requirements:

  • Native French speaker with expertise in healthcare and pharmaceutical industries.
  • Strong understanding of regulatory guidelines and standards.
  • Excellent communication and writing skills.
  • Ability to work independently and collaboratively as part of a team.


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