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Legal Escalation Reviewer

Job not on LinkedIn

🔥 28 minutes ago

🌐 United Kingdom, Poland – Remote

infoinfo

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧑‍💼 Attorney / Lawyer

Where this job comes from

Posted on ICON plc's careers page, not through a job board

First seen by Remote Rocketship 28 minutes ago

Logo of ICON plc

ICON plc

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

• Oversee site contracting performance and strategy across a defined portfolio of studies or customers • Ensure contracting is delivered predictably, efficiently, and in line with business and customer expectations • Manage day-to-day contract management activities and support the team to deliver quality outcomes • Manage and may lead day-to-day operations within the relevant support function in compliance with GCP/ICH guidelines and regulatory requirements • Communicate and coordinate with key business stakeholders, including study teams, to support timely completion of drug and non-drug program goals and objectives • Implement standards for designated functional areas • Manage and provide operational support for the global study operating model, including business processes and service-provider operating models • Optimize internal and external business process standards for Clinical Operations • Provide oversight and direction to team members for contract escalations • Proactively identify, risk-manage, escalate, and resolve issues arising with clinical site contracts • Develop and continuously update functional SOPs, the Astellas Global Contract Negotiations Playbook, and other relevant processes and tools • Liaise between site contract negotiators and designated legal partners to support global templates and processes and provide timely, strategic legal advice

🎯 Requirements

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree • Solid contract management experience • Ability to manage competing priorities and develop your team • Knowledge of clinical trial conduct, including, multi-center, global trials • Strong knowledge of ICH/GCP guidelines and regulatory requirements • Good understanding of regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to core and country templates • Experience with development & implementation of process improvement related initiatives • Strong analytical problem solving and decision-making skills • Ability to exercise sound judgment and provide practical and constructive legal advice • Strong negotiation and communication skills, both oral and written • Ability to communicate legal issues clearly and understandably • Excellent interpersonal, written and verbal communication skills • Administrative skills and computer ability • 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

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