Expert Medical Regulatory Writer
1 day ago
Barcelona
ph3Expert Medical Regulatory Writer – Barcelona, Spain /h3pSanofi Business Operations is an internal Sanofi resource organization based in India, centralizing processes to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and RD, Data Digital functions. The Real-World Evidence team seeks an Expert Medical Regulatory Writer in Barcelona, Spain. /ph3Overview /h3pIn 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. /ph3Main Responsibilities /h3ulliAuthor and/or lead the development of high-quality RWE documents, including:ulliRWE Study Protocols /liliClinical Study Reports (CSRs) /liliStatistical Analysis Plan (SAP) narrative sections /liliPeer-reviewed publications and congress abstracts /li /ul /liliEnsure all documents meet internal quality standards and external regulatory requirements /li /ulh3Study Design Methodology /h3pDemonstrate a clear understanding of observational study designs—including cohort, case-control, cross-sectional, registry and others—and justify the rationale for selecting a specific design based on scientific, regulatory, and operational factors. /ph3Statistical Interpretation /h3ulliAccurately interpret and communicate findings from a wide range of statistical outputs, such as hazard ratios, risk ratios, odds ratios, confidence intervals, p-values, standardized mean differences, Kaplan-Meier analyses, Cox proportional hazard models, logistic and linear regression /liliTranslate complex methodological decisions into clear, audit-ready documentation /li /ulh3Bias Confounding Management /h3ulliIdentify and communicate strategies for managing confounding and bias using propensity score methods, matching, stratification, and sensitivity analyses /liliTranslate complex methodological decisions into clear, audit-ready documentation /li /ulh3Real-World Data Expertise /h3ulliFamiliarity with real-world data sources such as claims databases, electronic health records, and patient registries /liliWorking knowledge of medical coding systems (ICD-9/ICD-10, CPT, NDC) and their application in study design and data analysis /li /ulh3Regulatory Frameworks Guidelines /h3ulliFDA Real-World Evidence Framework /liliFDA Guidance on Real-World Data and Real-World Evidence /liliEMA DARWIN EU initiative and related European regulatory guidance /liliProactively monitor the evolving RWE regulatory landscape and advise internal teams /li /ulh3Required Experience Qualifications /h3ulliAdvanced degree in life sciences, epidemiology, public health, pharmacy, medicine, or a related field (MSc, PharmD, MD, or PhD preferred) /liliMinimum 3–5 observational/RWE studies as a primary author or significant contributor /liliProven track record of authoring RWE documents /liliStrong command of English scientific writing with exceptional attention to detail /liliAbility to work independently and manage multiple projects in a fast-paced, cross-functional environment /li /ulh3Benefits /h3pSalary: €60,000-€80,000. Employees may be eligible to participate in company employee benefit programs. /ppAt Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. /p /p #J-18808-Ljbffr