Senior/Principal Medical Writer

🕒 May 13

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions. • Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs. • Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise. • Contributing to the development of publication plans, abstracts, posters, and manuscripts. • Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles.

🎯 Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field • Minimum of 4-7 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses. • Excellent writing, editing, and proofreading skills. • Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications. • Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables. • Excellent interpersonal and communication skills. • Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes.

🏖️ Benefits

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.