Medical Writer

• Job title: Clinical Medical Writer • Location: Budapest, Hungary • Job type: Fixed term (maternity cover) • Hybrid working About the job   Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?   Join our Global Research and Development organization’s Vaccines Clinical Documentation subgroup as Medical Writer (MW) and you will be an essential team member to produce high-quality clinical documents (content and format). This is a position for the first level of medical writing with increasing levels of autonomy over time. The incumbent takes responsibility for writing clinical protocols/synopses, core informed consents/assents, clinical study reports, lay summaries and synopsis, and investigator brochures according to Sanofi's standards, international government regulations, and guidelines established by the ICH.   The role provides critical support to clinical development programs by ensuring accurate, clear, and compliant documentation that supports regulatory approvals. Medical Writers work cross-functionally with multiple development functions (for ex. Clinicians, Biostatistics, Regulatory, Pharmacovigilance) and partners (for eg. CROs). Medical writing skills are also required for the development or validation of digital writing tools, using Artificial Intelligence.   This position is fixed-term (maternity cover) with an anticipated end in November 2027.   Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting.   Main responsibilities:   This is a position for an entry level medical writer who can take responsibility for the preparation of clinical documents   • Document Writing: Write clinical documents with increasing autonomy, including Phase I to IV clinical protocols, informed consent forms, clinical study reports, and investigators’ brochures. Ensure their timely completion, according to company SOPs and guidelines, with the ultimate aim to gain regulatory approval of therapeutic indications. • Quality Assurance & Consistency: Ensure a consistent style of presentation of the clinical documents to maintain quality. Perform data quality checks as required. • Common Technical Document preparation: Contribute to the production of clinical registration dossiers, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. • Cross-Functional Collaboration: Build and maintain good relationships with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and international counterparts in other departments, especially Regulatory Operations. • Knowledge Sharing & Professional Development: Share experience with other medical writers about accommodating special details of clinical studies not covered by the standards and about experience gained with advanced word-processing, graphics and other software.   About you Experience:   Experience as a medical writer (or equivalent) demonstrating the ability to write all types of simple documents in English