Medical Translator (English To Brazilian Portuguese; Portuguese To English)
CurrentTranslated and edited medical and clinical trial documentation. Ensured consistency with style guides, glossaries, and relevant regulations on clinical research. Recurrent documents include: • Clinical Trial Protocols;• Investigator Brochures (IBs);• Regulatory submissions and amendments with version control and tracked changes;• Informed Consent Forms (ICFs);• Clinical Study Reports (CSRs);• Periodic safety update reports (PSURs);• Development safety update reports… Show more Translated and edited medical and clinical trial documentation. Ensured consistency with style guides, glossaries, and relevant regulations on clinical research. Recurrent documents include: • Clinical Trial Protocols;• Investigator Brochures (IBs);• Regulatory submissions and amendments with version control and tracked changes;• Informed Consent Forms (ICFs);• Clinical Study Reports (CSRs);• Periodic safety update reports (PSURs);• Development safety update reports (DSURs);• Patient Information Leaflets and hospital handouts;• Patient questionnaires and linguistic validation of such questionnaires;• Queries from Regulatory Authorities and Ethics Committees reviewers, as well as responses to such queries;• Pharmacovigilance (capture and reporting of Serious Adverse Events and Product quality complaints). Show less