Clinical Medical Writer F/H
il y a 1 semaine
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
Key Activities :
Drafting of clinical study protocols, clinical study reports (CSRs) and summaries of product characteristics
Co-writing/writing of Clinical study reports (Phase 1 to 4)
Redaction of clinical documents, CRO operational oversight on different documents,
Narrative coordination with CRO oversight, as Medical Writer
EU CTR coordination tasks
Co-authoring of Clinical Modules of CTDs, Q&A, briefing books, benefit risk
As needed, participation to test new digital medical writing applications and tools
Profile :
- Good communication skills
- Interpersonal skills to facilitate communication and cooperation within the team
- Knowledge of local and international guidelines and regulations concerning the drafting of clinical documents.
- Ability to manage several projects simultaneously while meeting deadlines
- Good written and spoken English is essential
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Lyon, Rhône, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...
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