Clinical Evaluation Report Specialist
9 hours ago
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
- 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.
- 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
- 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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