Medical writer

• **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

Clinical Documentation Specialist

RN Clinical Documentation Specialist

Clinical Documentation Specialist

Registered Nurse, Clinical Documentation Specialist – CDIP, CCDS Required