Senior Medical Writer - Clinical Pharmacology & Pharmacometrics

About the role

ICON is a global healthcare intelligence and clinical research organisation. As a Senior Medical Writer, you will lead the development and execution of medical writing strategies for clinical research projects, delivering high-quality Clinical Pharmacology & Pharmacometrics (CPP) documents such as population PK/PD data transfer plans, analysis plans and reports, as well as CSRs, protocols and other documents, in line with the client's regulatory system and global aligned procedures.

Key responsibilities

• Write CSRs for phase 1 healthy volunteer trials and clinical pharmacology trials, and protocols for healthy volunteer studies
• Produce Module 2.7.1 and 2.7.2 documents
• Write clear, concise documents including study reports, protocols, investigator brochures, summary documents and other scientific documents
• Manage the document preparation process: receive and review primary statistical output, draft and distribute documents for review, and resolve reviewer comments
• Provide scientific and medical writing consultancy to project teams
• Ensure deliverables comply with client SOPs, WIs, policies, local regulatory requirements and ICH-GCP, and are inspection ready
• Maintain the central planning of population PK/PD document writing and QC deliverables, and communicate clearly with clinical pharmacology and pharmacometrics leaders

Required profile

• Advanced degree in Life Sciences, Pharmacy, Medicine or a related field
• Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology or CRO industry
• Strong understanding of regulatory requirements (ICH-GCP, FDA, EMA) and experience interacting with regulatory agencies
• Ability to work in a fast-paced, deadline-driven environment and manage multiple projects
• Excellent interpersonal and communication skills, able to collaborate across functions and influence decisions

Required skills

• Interpreting and summarising complex clinical trial data, research findings and statistical analyses
• Excellent writing, editing and proofreading skills
• Ability to explain scientific concepts to diverse audiences

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities