Medical Writer
Employer · Sanofi Group
Budapest
Sanofi Group is seeking a Medical Writer to join our Global Research and Development organization's Vaccines Clinical Documentation subgroup. This is an essential role to produce high-quality clinical documents with increasing levels of autonomy over time, supporting clinical development programs and regulatory approvals in a multicultural environment.
Tasks
- Write clinical documents with increasing autonomy, including Phase I to IV clinical protocols, informed consent forms, clinical study reports, and investigators' brochures
- Ensure timely completion of documents according to company SOPs and guidelines to gain regulatory approval of therapeutic indications
- Ensure a consistent style of presentation of clinical documents and perform data quality checks as required
- Contribute to the production of clinical registration dossiers, including overall EU or US clinical regulatory documentation
- Build and maintain good relationships with clinical personnel, internal clients, colleagues, and international counterparts
- Share experience with other medical writers about accommodating special details of clinical studies and advanced software usage
Conditions & benefits
Supportive international teamBring the miracles of science to life alongside a supportive, future-focused team in an international work environmentHybrid and flexible workWork from an Office of the Year 2025 award winner with flexible home office policyRewards packageEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impactHealth and wellbeingTake good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leaveOnboarding and mentoringAn individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeksCommunity eventsJoin a great community and special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures and Sport Clubs)
Requirements
- Experience as a medical writer or equivalent demonstrating the ability to write all types of simple documents in English in a clear, precise and concise manner
- Ability to work independently and proactively
- Sense of urgency and respect for deadlines
- Precise and meticulous work, attention to detail
- Strong work ethic, professionalism, organizational skills and ability to follow up
- Ability to work effectively in a multicultural and multilingual environment
- Technical proficiency in electronic document management and word processing software, especially Microsoft Word and Excel
- Knowledge or experience on Artificial Intelligence use in documentation and writing activities is advantageous
- Bachelor's degree or equivalent in a field related to science or life sciences (Postgraduate degree or Doctor of Pharmacy preferred)
- Professional experience in the field of medical writing or related field(s)
- Basic understanding and experience of basic statistics and experimental research
- Native or bilingual English speaker with an excellent command of spoken and written English (fluent level C1)