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 Differences (SMD)

• Kaplan-Meier analyses

• Cox Proportional Hazard Models

• Logistic and Linear Regression

Bias & Confounding Management

• Understand, identify, and clearly communicate strategies for managing confounding and bias in RWE studies, including propensity score methods, matching, stratification, and sensitivity analyses

• Translate complex methodological decisions into clear, audit-ready documentation

Real-World Data Expertise

• Demonstrate familiarity with real-world data sources such as claims databases, Electronic Health Records (EHR), and patient registries

• Working knowledge of medical coding systems (e.g., ICD-9/ICD-10, CPT, NDC) and their application in study design and data analysis

Regulatory Frameworks & Guidelines

• Stay current with and apply key regulatory frameworks and guidance documents, including:

• FDA Real-World Evidence Framework

• FDA Guidance on Real-World Data and Real-World Evidence

• EMA DARWIN EU initiative and related European regulatory guidance

• Proactively monitor the evolving RWE regulatory landscape and advise internal teams accordingly

Required Experience & Qualifications

• Advanced degree in Life Sciences, Epidemiology, Public Health, Pharmacy, Medicine, or a related field (MSc, PharmD, MD, or PhD preferred)

• Minimum 3–5 observational/RWE studies as a primary author or significant contributor

• Proven track record of authoring

• Strong command of English scientific writing with exceptional attention to detail

• Ability to work independently and manage multiple projects in a fast-paced, cross-functional environment

Pursue Progress. Discover Extraordinary.

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