Senior Medical Writer

About the role

About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents). The 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 Medical Writer will work alongside healthcare professionals, project managers, statisticians and other company functional groups to produce the medical writing deliverables . Main Responsibilities: To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures) in accordance with sponsors' and Excelya's SOPs, guidelines and applicable legislation. To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs). To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality. To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines). To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers. To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations. To 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 procedure To perform a literature review according to the project's requirements for its effective completion and according to the sponsors' and Excelya's SOPs To review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency To maintain familiarity with current industry practices and regulatory requirements, and guidelines that affect medical writing To assist with any other project or other teams (Medical Advisor, Medical Monitor) of the Medical Affairs Department as requested by the superior To support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers To act as a backup to other Senior Medical Writers and Medical Writers when needed About You At Excelya, taking audacious steps is encouraged , so we're looking for individuals who are ready to grow with us and share our values. - Experience: Senior Medical Writer, a relative experience of up to 3 years in medical writing is considered a plus. - Skills: -Analytical skills and ability to interpret data -Attention to detail -A strong work ethic -Intellectual curiosity and creativity -The ability to work effectively in a team in a fast-paced and dynamic environment -Advanced level of English -Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines -Interpersonal and leadership skills - Education: University graduate in life sciences or equivalent (post-graduate studies in a related field are considered a plus) - Languages: Fluency in English (mandatory) Why Join Us? At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here's what makes us unique. We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience . Our one-stop provider service model - offering full-service, functional service provider, and consulting - enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to en

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