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Sheffield, Sheffield, United Kingdom Publicis Groupe Full time{"h1": "Medical Writer - French Language Expert", "p": "At Publicis Groupe, 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.", "ul": [{"li":...
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Clinical Evaluation Report Specialist
2 months ago
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.
- Collaborate with researchers and authors to gather data and ensure accuracy in publications.
- 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.
