PstrongHays /strong is collaborating with an stronginternational pharmaceutical company specialized in the development, manufacturing, and commercialization of medicines /strong, with a strong focus on generics and a solid commitment to strongRD and clinical development /strong. /ppbr/ppThe project focuses on the strongreview and validation of clinical and bioanalytical documentation /strong within the Clinical Development area, in close collaboration with CROs and internal teams such as Quality and Pharmacovigilance. The team is currently in an active phase reviewing multiple clinical studies, with potential continuity depending on upcoming regulatory needs. /ppbr/ppWe are currently looking for a strongMedical Writer – Clinical Development (Freelance) /strong to support this project, working closely with the clinical team and external partners. /ppbr/ppstrongKey Responsibilities /strong /pp• Review strongclinical and bioanalytical documentation /strong, including strongClinical Study Reports (CSRs) /strong, PK/BE reports, and related materials /pp• Assess bioanalytical reports in compliance with strongICH M10 guidelines /strong /pp• Ensure strongconsistency across clinical, statistical, and bioanalytical data /strong /pp• Perform strongquality control (QC) /strong of documentation: PK data, adverse event reporting, and overall consistency /pp• Liaise with strongCROs /strong for document review and validation /pp• Support, when required, the review of strongstudy protocols and informed consent forms (ICFs) /strong /pp• Collaborate with internal stakeholders: strongClinical Development, QA, and Pharmacovigilance /strong /pp• Ensure compliance with regulatory standards (strongICH E3, E6, E9, M10; GCP /strong) /ppbr/ppstrongRequirements /strong /pp• strongConsiderable experience /strong as a Medical Writer in a clinical research environment /pp• Proven experience in strongclinical documentation (CSRs, protocols) and bioanalytical documentation /strong /pp• Strong knowledge of strongICH guidelines (E3, E6, E9, M10) /strong and strongGCP /strong (GLP is a plus) /pp• Experience working with strongCROs /strong /pp• Ability to work strongindependently /strong while collaborating with cross-functional teams /ppstrong• Advanced level of English /strong /ppbr/ppstrongNice to Have /strong /pp• Experience in strongpharmacokinetics and bioequivalence (PK/BE) /strong /pp• Knowledge of strongstatistics applied to clinical trials /strong /pp• Previous experience reviewing strongbioanalytical reports /strong /ppbr/ppstrongWhat We Offer /strong /pp• strongContract opportunity through Hays, /strongworking with an stronginternational pharmaceutical company /strong /ppstrong• Part-time project /strong (approximately 3 full days per week) /pp• Possibility of strong100% remote work /strong /pp• strongClose collaboration with the Clinical Development team /strong /pp• strongInitial duration of 4 months /strong(likely to extend) strongwith immediate start /strong /p