Pk medical writer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ikbyw

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. 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-fu

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ikbyw