Senior Medical Writer Location : Netherlands Reports to Head of Medical Writing As a Sr Medical Writer, you will be responsible for planning, writing, reviewing, editing, formatting, and finalising critical clinical documents such as study reports, protocols, investigator brochures, package inserts, and regulatory submissions. You will ensure that all documents adhere to regulatory standards and accurately reflect the scientific data, supporting our clinical development programs by providing clear and concise communication of scientific information. If you are a skilled Medical Writer with a passion for scientific communication, we encourage you to apply! Responsibilities Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to : Clinical study protocols and clinical protocol amendments Clinical study reports IND submissions and annual reports Integrated summary reports NDA, BLA, MAA, CTD submissions Health Authority responses Participate in relevant document subteam and ensure effective planning and management of timelines for all components of assigned documents across all projects / MWs. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. Maintain document prototypes and shells, proactively support developing and reviewing standard processes and templates. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents. Review and edit documents as required. Conduct literature reviews, as needed. Work effectively and lead cross-functional document working groups. Prepare clinical trial disclosures and registration datasets for ClinicalTrials.Gov, EudraCT, and CTIS and gain internal / registry approvals; and populate data within websites for public release. Qualifications Fluent in Englis...