Pk Medical Writer
Pubblicato il 27-09-2026 - Icon Clinical in Monza
pAs 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. /pulliHealth and wellbeing programmes /liliRetirement and pension plans /liliLife assurance and disability coverage /liliEmployee assistance programmes /liliLearning and development opportunities /liliLead the development and execution of CPP documents (e.g., population PK/PD data transfer plans, analysis plans, and reports) /liliProduce CSRs for phase 1 healthy volunteer and clinical pharmacology trials; develop protocols for healthy volunteer studies /liliManage the document preparation process: receive data, draft, circulate for review, and resolve reviewer comments /liliProvide scientific writing consultancy to project teams as requested /liliEnsure deliverables comply with client SOPs, WIs, regulatory requirements, ICH-GCP, etc.
/liliMaintain central planning for population PK/PD document writing and QC deliverables /liliPrepare and deliver clear study reports, protocols, investigator brochures, and summaries /liliCommunicate with CPP leaders and other team members to ensure timely, inspection-ready documents /liliAdvanced degree in Life Sciences, Pharmacy, Medicine, or related field; 3–5 years of medical writing experience in pharma/biotech/CRO /liliAbility to interpret and summarize complex clinical trial data and statistical analyses /liliExcellent writing, editing, proofreading, and communication skills for diverse audiences /liliStrong understanding of regulatory requirements (ICH-GCP, FDA, EMA) and experience with regulatory interactions /liliProven ability to work in fast-paced, deadline-driven environments and manage multiple projects /liliExcellent interpersonal and collaboration skills to work with cross-functional teams and stakeholders /liliclear communication /liliinterpretation and summarization of complex clinical data /lilistatistical analysis understanding /lilimedical writing proficiency /li /ul #J-18808-Ljbffr