28 set - Monza
Icon Clinical
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.Tutte le competenze, le qualifiche e l'esperienza necessarie per un candidato di successo sono elencate nella seguente descrizione.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 analyses xysqume Excellent 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 projectsExcellent interpersonal and collaboration skills to work with cross-functional teams and stakeholdersclear communicationinterpretation and summarization of complex clinical datastatistical analysis understandingmedical writing proficiency#J-18808-Ljbffr
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