Global Labelling Lead

Job not on LinkedIn

🔥 36 minutes ago

🌐 United Kingdom, United States – Remote

🇬🇧 United Kingdom – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 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

• Provide regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, and Commercial • Manage preparation of strategic labeling input for regulatory strategies and liaise with regulatory team members on submission and negotiation plans • Develop regulatory labeling strategies for new and revised prescribing information and packaging • Strategically interpret scientific, medical, and regulatory data and information • Advise on current labeling requirements, templates, tools, and Health Authority guidance for pharmaceutical drugs and devices • Work under the direction of the Head of Global Labeling

🎯 Requirements

• An undergraduate degree in a relevant field of study • Extensive experience and a proven track record of success in Regulatory Labeling • Advanced knowledge of the scientific principles of the drug development process • Advanced, broad knowledge of regulations pertaining to drug product labeling • Excellent oral and written communication skills • Excellent project management skills • Excellent critical thinking skills • Excellent attention to detail • 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