[Hiring] Legal Escalation Reviewer @ICON plc

Role Description

As a Legal Escalation Reviewer at ICON, you will oversee site contracting performance and strategy across a defined portfolio of studies or customers. You will ensure contracting is delivered predictably, efficiently, and in line with business and customer expectations.

You will manage day-to-day contract management activities, supporting your team to deliver quality outcomes.

• Manage and may lead the day-to-day operations within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Responsible for implementation of standards for designated functional areas.
• Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CO business processes and service provider related operating models (CRO, IRT, Central Lab).
• Manage the sustainability and optimization of internal and external business process standards for Clinical Operations.
• Provide oversight and direction to team members for contract escalations.
• Work with site contract team to proactively identify, risk-manage, including escalation and resolve issues that arise with clinical site contracts.
• Drive and/or contribute to the development and/or continuous update(s) to functional SOPs, Astellas Global Contract Negotiations Playbook and other relevant core processes and tools.
• Serve as liaison to collaborate between site contract negotiators and designated legal partners (as needed) to support development or update to global templates and processes.

Qualifications

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree.
• 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 the core and country templates.
• Experience with development & implementation of process improvement related initiatives.
• Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice.
• Strong negotiation and communication skills (both oral and written).
• Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

Requirements

• Must have the 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.
• Benefits may vary depending on role and location.

Company Description

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.