Medical Content Specialist
3 days ago
About Translate Plus
We are a leading provider of translation and localization services, and we are seeking a highly skilled Medical Content Specialist to join our team.
Job Summary
The Medical Content Specialist will be responsible for translating complex scientific and clinical information into clear and concise documents for various audiences, including healthcare professionals, regulatory agencies, and the public.
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.
- Prepare safety-related documents such as periodic safety update reports (PSURs), risk management plans, and other safety documents required for regulatory submissions.
- Assist in the preparation of clinical trial disclosure documents, including results summaries for posting on clinical trial registries.
- 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 of medical writing experience.
- PHD is preferred.
- French native speaker - Mandatory.
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