Principal Medical Writer

16 hours ago

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ICON plc

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ICON plc is a leading global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They specialize in a full range of services, including clinical trial management, regulatory affairs, and patient recruitment, aiming to advance the development of transformative therapies across various sectors. ICON employs innovative technology and data solutions to streamline the drug development process and ensure effective clinical outcomes for patients.

Medical Device • Therapeutics • Government and Public Health Solutions • Clinical Research Services • Commercialisation and Outcomes

10,000+ employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• 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 • Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.) • Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents • 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

🎯 Requirements

• Advanced degree in a relevant scientific/clinical/regulatory field preferred • At least 5 years of experience in a lead medical writing role in the pharmaceutical/CRO industry • Note: Immunology experience is preferred but not required • 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 maximise 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