Medical Writer Medical Device

Excelya>Full-time>Medical Writer Medical Device

Job description

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 800 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.

 

Responsibilities :

Due to a high level of medical writing activity within the medical device business, we are looking for a medical writer, who will be responsible for writing the various documents required for the development of medical devices:

– CEP, CER, PMCF plan and report, PMS plan and report:

– Compilation and synthesis of data provided by the different stakeholders

– Drafting of documents

– Follow-up of review cycles, implementation of comments and consolidation for final version.

Requirements :

  • Higher scientific education (doctor of medicine, pharmacist, doctor of science…),
  • At least 2 years experience in medical writing related to medical devices (laboratory, CRO or medical writing service providers)
  • Mastery of professional English is essential (spoken, read and especially written).
  • Mastery of the European Medical Device Regulation and knowledge of the requirements for clinical evaluation documents and related to PMS

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