PbHays /b is collaborating with an binternational pharmaceutical company specialized in the development, manufacturing, and commercialization of medicines /b, with a strong focus on generics and a solid commitment to bRD and clinical development /b. /ppbr/ppThe project focuses on the breview and validation of clinical and bioanalytical documentation /b 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 bMedical Writer – Clinical Development (Freelance) /b to support this project, working closely with the clinical team and external partners. /ppbr/ppbKey Responsibilities /b /pp• Review bclinical and bioanalytical documentation /b, including bClinical Study Reports (CSRs) /b, PK/BE reports, and related materials /pp• Assess bioanalytical reports in compliance with bICH M10 guidelines /b /pp• Ensure bconsistency across clinical, statistical, and bioanalytical data /b /pp• Perform bquality control (QC) /b of documentation: PK data, adverse event reporting, and overall consistency /pp• Liaise with bCROs /b for document review and validation /pp• Support, when required, the review of bstudy protocols and informed consent forms (ICFs) /b /pp• Collaborate with internal stakeholders: bClinical Development, QA, and Pharmacovigilance /b /pp• Ensure compliance with regulatory standards (bICH E3, E6, E9, M10; GCP /b) /ppbr/ppbRequirements /b /pp• bConsiderable experience /b as a Medical Writer in a clinical research environment /pp• Proven experience in bclinical documentation (CSRs, protocols) and bioanalytical documentation /b /pp• Strong knowledge of bICH guidelines (E3, E6, E9, M10) /b and bGCP /b (GLP is a plus) /pp• Experience working with bCROs /b /pp• Ability to work bindependently /b while collaborating with cross-functional teams /ppb• Advanced level of English /b /ppbr/ppbNice to Have /b /pp• Experience in bpharmacokinetics and bioequivalence (PK/BE) /b /pp• Knowledge of bstatistics applied to clinical trials /b /pp• Previous experience reviewing bbioanalytical reports /b /ppbr/ppbWhat We Offer /b /pp• bContract opportunity through Hays, /bworking with an binternational pharmaceutical company /b /ppb• Part-time project /b (approximately 3 full days per week) /pp• Possibility of b100% remote work /b /pp• bClose collaboration with the Clinical Development team /b /pp• bInitial duration of 4 months /b(likely to extend) bwith immediate start /b /p