PK Medical Writer
Pubblicato il 23-08-2026 - Experteer Italy in Milano
As a Senior Medical Writer at ICON, you lead medical writing strategies for clinical pharmacology and pharmacometrics projects, delivering high-quality CST and regulatory documents. You will drive the document development process, interact with cross-functional teams, and ensure adherence to regulatory standards. This role offers the opportunity to shape pharmacometric communications that support faster patient access to innovative therapies. You will work in a fast-paced, collaborative environment with a focus on impact and quality.Health and wellbeing programmesRetirement and pension plansLife assurance and disability coverageEmployee assistance programmesLearning and development opportunitiesLead the development and execution of CPP documents (e.g., population PK/PD data transfer plans, analysis plans, and reports)Produce CSRs for phase 1 healthy volunteer and clinical pharmacology trials; develop protocols for healthy volunteer studiesManage the document preparation process: receive data, draft, circulate for review,
and resolve reviewer commentsProvide scientific writing consultancy to project teams as requestedEnsure deliverables comply with client SOPs, WIs, regulatory requirements, ICH-GCP, etc.Maintain central planning for population PK/PD document writing and QC deliverablesPrepare and deliver clear study reports, protocols, investigator brochures, and summariesCommunicate with CPP leaders and other team members to ensure timely, inspection-ready documentsAdvanced degree in Life Sciences, Pharmacy, Medicine, or related field; 3–5 years of medical writing experience in pharma/biotech/CROAbility to interpret and summarize complex clinical trial data and statistical analysesExcellent writing, editing, proofreading, and communication skills for diverse audiencesStrong understanding of regulatory requirements (ICH-GCP, FDA, EMA) and experience with regulatory interactionsProven ability to work in fast-paced, deadline-driven environments and manage multiple proj