Job title: Expert Medical Regulatory Writer

Location: Barcelona, Spain

Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D;, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

About the job
We are looking for an Expert Regulatory Writer to join our growing Real-World Evidence team. In this role, you will be at the intersection of science, data, and regulatory strategy — translating complex observational research into clear, compelling, and compliant scientific documents. You will collaborate closely with epidemiologists, biostatisticians, medical affairs, and regulatory teams to support the full lifecycle of RWE studies.

Main responsibilities:
Scientific & Regulatory Writing
Author and/or lead the development of high-quality RWE documents, including:
• RWE Study Protocols




• Clinical Study Reports (CSRs)
• Statistical Analysis Plan (SAP) narrative sections
• Peer-reviewed publications and congress abstracts
• Ensure all documents meet internal quality standards and external regulatory requirements

Study Design & Methodology
Demonstrate a clear understanding of observational study designs including Cohort, Case-Control, Cross-Sectional, Registry, External Comparator/Control Arm, Prospective/Retrospective, Drug Utilization, Safety, and Effectiveness studies
• Articulate and justify the rationale for selecting a specific study design over alternatives on a case-by-case basis, considering scientific, regulatory, and operational factors

Statistical Interpretation
Accurately interpret and communicate findings from a wide range of statistical outputs, including:
• Hazard Ratios, Risk Ratios, Odds Ratios
• Confidence Intervals and P-values
• Standardized Mean Dif

📌 Expert Medical Regulatory Writer (Barcelona)
🏢 Sanofi
📍 Barcelona