Legal Escalation Reviewer

KCR Placement; Reading; Remote; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Legal Escalation Reviewer to oversee site contracting performance across a defined portfolio, ensuring predictable and compliant contracting aligned with business goals. You will manage daily contract activities and lead escalation resolution while coordinating with stakeholders to support drug and non-drug program objectives.

The role requires strong contract management experience, knowledge of ICH/GCP guidelines, and excellent negotiation and communication

Qualifications

• BA/BS degree with ≥5 years of pharmaceutical-related drug development experience.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Experience with development & implementation of process improvement initiatives.
• Excellent negotiation and communication skills, both written and spoken.

Responsibilities

• Manage day-to-day contract management activities and support the team to deliver quality outcomes.
• Implement standards for designated functional areas within contracts.
• Provide operational support for global study operating models and related processes.
• Oversee contract escalations and guide team members.
• Collaborate with site contract negotiators and legal partners to update global templates and processes.
• Identify and mitigate risks in site contracts and ensure timely issue resolution.

Skills

Contract management

Regulatory knowledge

GCP/ICH knowledge

Negotiation

Communication skills

GDPR awareness

Education

BA/BS degree

Advanced degree

Job description

Legal Escalation Reviewer

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.

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.

What You Will Do:

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

Key responsibilities include:

• 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. This includes 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) and/or
• Manage the sustainability and optimization of internal and external business process standards for Clinical Operations and/or
• Provide oversight and direction to team members for contract escalations
• Works 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.
• Serves as liaison to collaborate between site contract negotiators and designated legal partners (as needed) to support development or update to global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business.

Your Profile:

You will have solid contract management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
• Must have knowledge of clinical trial conduct, including, multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Good understanding of the 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). Ability to communicate legal issues in a clear and understandable manner.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

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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.

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