Freelance medical writer - clinical development

Haysis collaborating with aninternational pharmaceutical company specialized in the development, manufacturing, and commercialization of medicines, with a strong focus on generics and a solid commitment toR&D and clinical development .The project focuses on thereview and validation of clinical and bioanalytical documentationwithin 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.We are currently looking for aMedical Writer – Clinical Development (Freelance)to support this project, working closely with the clinical team and external partners.Key Responsibilities - Reviewclinical and bioanalytical documentation, includingClinical Study Reports (CSRs), PK/BE reports, and related materials - Assess bioanalytical reports in compliance withICH M10 guidelines - Ensureconsistency across clinical, statistical, and bioanalytical data - Performquality control (QC)of documentation: PK data, adverse event reporting, and overall consistency - Liaise withCROsfor document review and validation - Support, when required, the review ofstudy protocols and informed consent forms (ICFs) - Collaborate with internal stakeholders:Clinical Development, QA, and Pharmacovigilance - Ensure compliance with regulatory standards ( ICH E3, E6, E9, M10;
GCP )Requirements - Considerable experienceas a Medical Writer in a clinical research environment - Proven experience inclinical documentation (CSRs, protocols) and bioanalytical documentation - Strong knowledge ofICH guidelines (E3, E6, E9, M10)andGCP(GLP is a plus) - Experience working withCROs - Ability to workindependentlywhile collaborating with cross-functional teams - Advanced level of EnglishNice to Have - Experience inpharmacokinetics and bioequivalence (PK/BE) - Knowledge ofstatistics applied to clinical trials - Previous experience reviewingbioanalytical reportsWhat We Offer - Contract opportunity through Hays,working with aninternational pharmaceutical company - Part-time project(approximately 3 full days per week) - Possibility of100% remote work - Close collaboration with the Clinical Development team - Initial duration of 4 months(likely to extend)with immediate start