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.

Tutte le competenze, le qualifiche e l'esperienza necessarie per un candidato di successo sono elencate nella seguente descrizione.

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 xysqume

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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