Expert Medical Regulatory Writer

Sanofi - Hyderabad, Telangana - 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), Product and Disease ID Cards, clinical evaluation report, Briefing packages, responses to Health Authorities Queries, and immunogenicity reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents acting as an SME on clinical...