Expert Medical Regulatory Writer

Job description

Job title: Expert Medical Regulatory Writer Location: Barcelona: % of travel expected: Travel required as per business need Job type: Permanent and Full time About the job: 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. Main responsibilities: - Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including complex Clinical Study Reports (CSR), complex CTD submission documents (clinical overview [CO], summary of clinical efficacy [SCE], clinical safety [SCS], clinical pharmacology [SCP], and biopharmaceutics [SBP]), medical section of Periodic Benefit-Risk Evaluation Report (PBRER), medical sections of addendum to clinical overview (ACO), Risk Management Plans (RMP), Produ...