Medical writer

• **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.
• **Main responsabilities : **
• - Ensure full compliance with internal and external SOPs, industry guidelines, and applicable legislation.
• - Conduct literature reviews as required by project specifications.
• - Write, edit, and deliver a range of medical and clinical documents (protocols, CSR, CTD submissions, ICFs, IBs, manuscripts, posters, etc.).
• - Review and perform quality control on medical writing deliverables for data accuracy, formatting, and regulatory compliance.
• - Review statistical documents (SAPs, tables, listings) for clarity, format, and consistency.
• - Maintain up-to-date knowledge of medical writing standards, regulations, and best practices.
• - Collaborate cross-functionally with internal teams (data management, biostats, project management) to ensure quality and timely delivery.
• - Act as a mentor and provide guidance to junior and senior medical writers on complex projects.
• - Identify and escalate project quality issues to management as appropriate.
• - Support project management and financial offer preparation for medical writing activities.
• - Participate in drafting and reviewing internal SOPs and training documents related to medical writing.

Principal Medical Writer

Principal Medical Writer