ICON plc
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.
Senior Medical Writer
Job not on LinkedIn
November 19
ICON plc
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
• Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. • Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. • Exhibits excellent written and oral communication and presentation skills. • Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.). • Manages all aspects of the medical writing function. • Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents. • Contributes to clinical protocol development for first-in-human oncology studies. • Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers. • Acts as a lead medical writer on complex programs and numerous individual studies. • Provides scientific and medical writing consultancy to project teams, as requested.
🎯 Requirements
• Advanced degree in a relevant scientific/clinical/regulatory field preferred • At least 3-5 years of experience in a lead oncology medical writing role in the pharmaceutical/CRO industry. • *Note: oncology experience is preferred. • Experience in regulatory writing - Protocols, CSRs, IBs • Excellent writing skills. • Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences. • Knowledge of current requirements and guidelines applicable to submission documents • Excellent interpersonal and oral communication skills. • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook • Ability to prioritize multiple projects
🏖️ 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.
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