Senior Medical Writer – Europe

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.

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

Excelya is looking to hire a Senior Medical Writer in charge of producing with experienced & well-defined input medical writing deliverables (both regulatory and medical communication documents).

The Senior Medical Writer will draft the reference documents for clinical studies, other research involving the human person and research not involving the human person and which must be part of the authorization request file from the Competent Authorities, such as the protocol, the summary of the protocol, the information and consent form, the observation booklet and any patient questionnaires and the investigator brochure.

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

The position is remote-based and we will happy to consider people who are based and can legally work in one of the following European countries: (Greece, Hungary, Bulgaria, Poland, France, Netherlands, Belgium, Germany, UK).

General Responsibilities/Tasks

• Acknowledge and strictly comply with sponsors’ and Excelya’s SOPs, guidelines and appropriate local and international legislation. To keep himself/herself continuously informed on any amendments or updates of the above-mentioned guidelines, applicable laws and procedures
• Perform literature review according to the projects requirements for its effective completion and according to the sponsors’ and Excelya’s SOPs
• 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
• Contribute to document quality control (reviewing data accuracy, formatting and appropriateness of language, and compliance to industry guidelines)
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency
• Ensure the accuracy of all information, data and references for the publications/documents produced
• Maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing
• Assist in any other project or other teams (Medical Advisor, Medical Monitor) of the Medical Affairs Department as requested by the superior
• Design and assist in the coordination of the execution of all the deliverables
• 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
• Liaise with sponsors to negotiate changes where necessary
• Mentor and lead less experienced Medical Writers on complex projects, as necessary
• Support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers
• Act as a backup to other Senior Medical Writers and Medical Writers when needed