We’re Hiring: Medical Writer & Medical MonitorAre you passionate aboutclinical developmentand looking for a role where you can combinemedical writing, medical monitoring, and scientific expertise ?AtCrovelis, we are looking for aMedical Writer & Medical Monitorto join our team and play a key role across our clinical development programmes and studies.This is a unique opportunity to combine two key areas:You will work closely withClinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and external investigators, contributing to both the scientific quality of clinical documentation and the medical oversight of clinical trials.What will you be doing?As a Medical Writer, you will:Draft, review, and maintain key clinical and regulatory documentation.Contribute toClinical Study Protocols, Protocol Amendments, Investigator’s Brochures, Clinical Study Reports, and Informed Consent Forms .Preparesafety narrativesand support regulatory submission documents.Contribute todevelopment plans, briefing documents,



and responses to regulatory authorities.Support the preparation ofscientific publications, abstracts, posters, and manuscripts .Coordinate cross-functional document reviews and ensure scientific accuracy, consistency, and compliance with applicable regulations.As a Medical Monitor, you will:Provide ongoing medical oversight for assigned clinical studies.Act as a medical point of contact for investigators and clinical sites.Review safety data, includingAEs, SAEs, AESIs, laboratory results, ECGs, and other clinically relevant findings.Collaborate withPharmacovigilanceteams on the identification and assessment of safety signals.Review protocol deviations and assess their potential impact on patient safety and study integrity.Participate inData Review Meetings, Safety Review Committees, and, where applicable,Data Monitoring Committees .Contribute to medical review of clinical data ahead ofdatabase lock .Support the preparation and review ofD

📌 Medical Writer (Madrid)
🏢 Crovelis
📍 Madrid