Clinical Evaluation Report Specialist

9 hours ago


Sheffield, Sheffield, United Kingdom Publicis Groupe Full time

About translate plus

translate plus is a leading international Language Services Provider, part of the Publicis Groupe network. We offer a range of services, including translation, interpretation, and content creation, to help businesses communicate effectively with their global audiences.

Job Description

We are seeking a highly skilled Medical Writer to join our team. As a Medical Writer, you will be responsible for translating complex scientific and clinical information into clear and concise documents for our clients in the healthcare and pharmaceutical industries.

Key Responsibilities

  1. Clinical and Regulatory Writing
  • 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.
Publication Writing
  • Contribute to the development of manuscripts, abstracts, and posters for publication in scientific journals and presentations at conferences.
  • Collaborate with researchers and authors to gather data and ensure accuracy in publications.
Scientific Communication
  • Communicate complex scientific and medical information in a clear and understandable manner for diverse audiences, including healthcare professionals, patients, and the general public.
Drug Safety Documents
  • Prepare safety-related documents such as periodic safety update reports (PSURs), risk management plans, and other safety documents required for regulatory submissions.
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

  • 10+ years medical writing experience.
  • PHD is preferred.
  • French native speaker - Mandatory.

About Publicis Groupe

Publicis Groupe is a global advertising corporation that operates a network of agencies and companies. We are committed to delivering innovative and effective marketing solutions to our clients.



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