Pk Medical Writer
Pubblicato il 27-09-2026 - Icon Clinical in Monza
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 programmes
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes
- Learning and development opportunities
- 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
- 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
- clear communication
- interpretation and summarization of complex clinical data
- statistical analysis understanding
- medical writing proficiency
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