Senior Medical Writer

🔥 2 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Lead the development and execution of medical writing strategies for clinical research projects • Independently produce clinical and regulatory documents in collaboration with Principal/Senior Principal Medical Writers • Develop documents including Clinical Study Protocols and Clinical Study Reports across Phase 1 to Phase 3 and multiple therapeutic areas • Analyze and critically interpret data to determine the best approach to composing each document • Apply lean writing strategies • Act as the primary contact for study teams regarding document preparation, planning, and timelines • Facilitate document reviews and ensure documents are submission-ready and finally approved • Collaborate directly with QC personnel and publishing specialists during document preparation • Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles • Foster excellence, collaboration, and continuous learning within the medical writing team

🎯 Requirements

• 3-5 years of experience as regulatory writer • Mandatory protocol writing experience in Phase II or III • CSR experience is good to have • Bachelor's degree in a relevant scientific discipline or healthcare-related field • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses • Excellent writing, editing, and proofreading skills • Strong understanding of regulatory requirements, including ICH-GCP, FDA, and EMA, governing the preparation and submission of clinical documents and publications • Experience interacting with regulatory agencies during the review and approval process • Excellent interpersonal and communication skills • Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes • Legal right to work in the country where the role is based

🏖️ Benefits

• 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