17 set - Pavia
Icon Clinical
Overview
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.
Retribuzione / Benefits
Competitive base salary
Health and wellbeing programmes
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes
Learning and development opportunities
Responsabilità
Lead 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 studies
Manage the document preparation process: receive data, draft, circulate for review, and resolve reviewer comments
Provide scientific writing consultancy to project teams as requested
Ensure deliverables comply with client SOPs, WIs,
regulatory requirements, ICH-GCP, etc.
Maintain central planning for population PK/PD document writing and QC deliverables
Prepare and deliver clear study reports, protocols, investigator brochures, and summaries
Communicate with CPP leaders and other team members to ensure timely, inspection-ready documents
Requisiti fondamentali
Advanced degree in Life Sciences, Pharmacy, Medicine, or related field; 3–5 years of medical writing experience in pharma/biotech/CRO
Ability to interpret and summarize complex clinical trial data and statistical analyses
Excellent writing, editing, proofreading, and communication skills for diverse audiences
Strong understanding of regulatory requirements (ICH-GCP, FDA, EMA) and experience with regulatory interactions
Proven ability to work in fast-paced, deadline-driven environments and manage multiple projects
Excellent interpersonal and collaboration skills to work with cross-functional teams and stakeholders
collaboration
clear communication
stakeholder engagement
interpretation and summarization of complex clinical data
statistical analysis understanding
medical writing proficiency
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