Description
As a Senior Medical Writer at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will be responsible for communicating complex scientific and medical information to diverse audiences, ensuring clarity, accuracy, and compliance.
Key responsibilities:
- Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for new medical devices
- Maintain and update existing CEPs, CERs, and Post-Market Clinical Follow-up Plans and Reports (PMCFP/PMCFRs)
- Review, compile, and analyze clinical and scientific data from multiple sources
- Identify potential clinical evidence gaps and contribute to recommendations and strategic decision-making
- Collaborate with cross-functional teams to prepare accurate, high-quality, and compliant documentation
- Analyze complex documentation or process-related issues and identify opportunities to improve quality, efficiency, and ways of working
- Establish and manage timelines for assigned deliverables in collaboration with project management
Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
- Strong medical device experience
- Experience in writing and developing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and other clinical/study documentation
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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 wellbeing resources
- Learning and development opportunities through structured training and career pathways
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