Senior Medical Writer – Europe

Excelya is one of the leading independent CRO in Europe, it is founded in 2014 and it is a people-centered Contract Research Organization (CRO) that excels with care.

In Excelya, our mission is to offer our collaborators a human and authentic experience within a young and ambitious healthcare company that is becoming a leader in clinical research in Europe. Excelya develops, in connection with experts, scientific, managerial, and human know-how that contributes to better take into account patients’ expectations. Excelya’s vision is to achieve new advances in the field of healthcare. This includes the discovery of new molecules, new vaccines, new treatments, but also a better understanding of patient behaviors, a continuous control of regulations, and expertise in research development.

Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe thanks to our 900 Excelyates. 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.

To learn more about us, visit www.excelya.com.

Excelya is currently seeking an experienced Medical Writer, who can work as a part-time freelancer. The position is full remote and can work from any EU country.

The role:

The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents) with experienced and well-defined input.

The Medical Writer will draft the medical documents required for clinical research, such as the protocol, the study report, and the informed consent form.

The Medical Writer will work alongside healthcare professionals, project managers, biostatisticians, and other company functional groups to produce the medical writing deliverables.

General Responsibilities/Tasks:

1. To write and edit medical writing deliverables (including clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures, Lay Summaries as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) according to the sponsors’ and Excelya’s SOPs
2. To contribute to document quality control (reviewing data accuracy, formatting and appropriateness of language, and compliance to industry guidelines)
3. To maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
4. To liaise with other functional groups or departments (e.g., data management, statistical programming, biostatistics, project management) to ensure timely delivery and quality of writing deliverables