EARON International leader in life sciences recruitment is looking for a Medical Writer for its client, an international CRO based in Paris.
- Scientific writing support for pre-clinical and clinical study documents.
- You will have considerable direct contact with clients, especially with the clinical teams and will work together at the company with Clinical Data Managers, and Statisticians to produce high quality documents.
- Write investigational medicinal product dossiers, investigator brochures, clinical study concept protocols, protocols and protocol amendments, informed consent forms, assent forms, clinical study reports, and summary (Module 2) documents for licensing applications
- Compile and publish complex documents (e.g., clinical study reports)
- Write patient narratives and other pharmacovigilance documents (e.g., DSURs, PBRERs, RMPs)
- Write and edit publications for peer-reviewed scientific/medical journals
- Write abstracts, posters and presentations for scientific congresses
- Translate scientific articles, clinical documents and media materials
- Perform reviews of the literature
- Participate in review of statistical analysis plans and provide input on the layout of Tables, Figures and Listings
- Maintenance of internal databases for the company or clients
- Perform Quality Control and/or peer reviews of documents generated by the company or clients Participate in marketing support
- Ensure that document and standards timelines are met
- Participate in the creation, usage and maintenance of the company document templates and SOPs.
- Graduate or post-graduate degree in medicine, pharmacy, or a scientific field
- 3-5 years experience writing CSRs is a must
- Experience writing clinical overviews is an asset
- Fluent in English with an excellent written proficiency in the language Computer literacy (Word, PowerPoint, Excel)
- Good team player and flexible