Expert Medical Regulatory Writer

Expert Medical Regulatory Writer – Barcelona, Spain

Sanofi Business Operations is an internal Sanofi resource organization based in India, centralizing processes to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. The Real-World Evidence team seeks an Expert Medical Regulatory Writer in Barcelona, Spain.

Overview

In this role you will translate complex observational research into clear, compelling and compliant scientific documents. You will collaborate with epidemiologists, biostatisticians, medical affairs and regulatory teams to support the full lifecycle of real-world evidence studies.

Main Responsibilities

• 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
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