Expert Medical Regulatory Writer - Barcelona

Solo para miembros registrados Barcelona, España

hace 18 horas

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Job title: Expert Medical Regulatory Writer

Expert Medical Regulatory Writer writes and/or edits 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 CTD submission documents clinical overview CO summary of clinical efficacy SCE clinical safety SCS clinical pharmacology SCP 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 trial transparency documents with added knowledge expertise


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