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.

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply