Medical Writer - France

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.

What we offer:

Compiling, writing, reviewing and editing medical writing deliverables (clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures, as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) for a variety of audiences with minimal supervision
Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
Ensuring the accuracy of all information, data and referencing for the publications/documents produced
Working closely with clients, physicians and investigators
Contributing ideas for business proposals and new projects
Adhering to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
Maintaining familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing

Minimum Requirements :

Bachelor’s degree in a scientific field or equivalent and relevant formal academic/vocational qualification.
Proven experience as a Medical Information Writer that provides the knowledge, skills, and abilities to perform the job
Experience working in the pharmaceutical/CRO industry preferred.
Ability to interpret and present complex data accurately and concisely.
Good knowledge of regulatory documentation and drug development process.
Good computer skills and skilled with client templates.
Good knowledge of document management systems and other relevant applications (e.g. Word, Excel, Outlook).