Medical Writer - France - product launch
Non Stop is currently looking for a Medical Writer on behalf of a pharmaceutical group developing innovative diagnostic and therapeutic products in the field of Nuclear Medicine. As part of their development, your key tasks will be the following:
- Providing medical writing expertise for multiple compounds and/or projects. Interfaces with external and internal teams (e.g. clinical investigators, external advisors, pharmaceutical development, preclinical, clinical, data management, regulatory) to ensure accurate and timely completion and review of clinical regulatory submissions.
- Implementing all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (EU and US).
- Coordinating the review, approval, and other appropriate functions involved in the production of clinical documents e.g. investigator brochures, study protocols and amendments, patient information and informed consent forms, study manuals, clinical trials reports, elements of CTD Modules 2, 4 and 5.
The candidate has a minimum of 3 years of medical writing experience in a clinical research environment. English fluent only.
If you are interested in this position, please contact Chloé Khatcherian on 0033 1 76 75 33 40 for further information or send your CV in word format to firstname.lastname@example.org