Senior Medical Writer

Senior Medical Writer At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

The Medical Writee is responsible for communicating complex scientic and medical information to diverse audiences, ensuring clarity, accuracy, and compliance, working under some supervision.

The role produces clean, clear, concise, and compliant documentation through advanced-level use of standard software tools and systems and the application of internal procedures and templates and external standards, regulations, and guidance.

The role authors and maintains Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up Plans (PMCFPs), and Post-Market Clinical Follow-up Reports (PMCFRs), Summary of Safety and Clinical Performance (SSCPs), and heavily contributes to Periodic Safety Update Reports (PSURs).

Responsibilities: Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for new medical devices, while maintaining and updating existing CEPs, CERs, and Post-Market Clinical Follow-up Plans and Reports (PMCFP/PMCFRs) in accordance with MEDDEV 2.7.1 Rev. 4 and EU MDR requirements.

Ensure high standards of Good Documentation Practices (GDP), maintaining the accuracy, quality, consistency, and compliance of clinical documentation in line with regulatory requirements and internal procedures.

Review, compile, and analyze clinical and scientific data from multiple sources, including clinical studies, post-market surveillance, risk management documentation, and published literature, to evaluate medical device safety and performance. Identify potential clinical evidence gaps and contribute to recommendations and strategic decision-making regarding clinical evaluation activities.

Collaborate with cross-functional teams to prepare accurate, high-quality, and compliant documentation using established tools, templates, and internal processes. 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, ensuring documents are completed on time and to the required quality and regulatory standards. Work independently on assigned activities while receiving guidance and supervision as required.

Requirements: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.

Proficiency in scientific and medical terminology, with excellent written and verbal communication skills, attention to detail, and the ability to convey complex information in a clear and concise manner. Strong medical device experience.

Experience in writing and developing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and other clinical/study documentation. #LI-Remote #LI-NR1 Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits 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 Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee?

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