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
PK Medical Writer datore di lavoro: Icon Clinical PLC
Lavorare come Global Study Manager in questa azienda significa entrare a far parte di un ambiente stimolante e collaborativo, dove la tua esperienza nella gestione di studi clinici avrà un impatto diretto sullo sviluppo di nuovi farmaci. Offriamo un pacchetto retributivo competitivo, opportunità di crescita professionale e un forte impegno verso il benessere dei dipendenti, con benefit che includono copertura sanitaria, piani pensionistici e programmi di formazione continua. La nostra cultura aziendale è guidata da valori etici e dalla volontà di innovare, rendendo ogni giorno un'opportunità per contribuire a risultati significativi a livello globale.
