Job title: Clinical Medical Writer
Location: Budapest, Hungary
Job type: Fixed term (maternity cover), anticipated end in November 2027
Hybrid working
About the job
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.
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 in a clear, precise and concise manner, e.g. experience in scientific writing, editorial experience, etc.
Soft Skills:
•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 required.
Technical skills:
•Technical proficiency in electronic document management and word processing software required, especially Microsoft Word and Excel.
•Knowledge / experience on Artificial Intelligence use in documentation and writing activities is advantageous.
Education:
•Bachelor's degree or equivalent in a field related to science or life sciences. Scientific advanced degree or with equivalent relevant experience (Postgraduate degree or Doctor of Pharmacy preferred).
•Professional experience in the field of medical writing or related field(s).
•Experience demonstrating a basic understanding, and preferably experience, of basic statistics and experimental research.
Language(s):
•Native or bilingual English speaker with an excellent command of spoken and written English (fluent level C1).
Why choose us?
•Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment.
•Work from an "Office of the Year 2025" award winner with flexible home office policy.
•Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
•Take 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 leave.
•An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.
•Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).
The salary range for this position is Ft10,944,000.00 - Ft16,416,000.00. Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
