Legal Escalation Reviewer

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Supervise the performance and strategic direction of site contracting across a specified portfolio of studies or clients.

• Ensure that contracting is executed in a predictable and efficient manner, aligning with business and customer expectations.

• Oversee daily contract management operations and assist the team in achieving high-quality results.

• Manage and potentially lead the daily operations within the relevant support function, adhering to GCP/ICH guidelines and regulatory standards.

• Communicate and collaborate with key business stakeholders, including study teams, to facilitate the timely achievement of drug and non-drug program goals and objectives.

• Establish standards for assigned functional areas.

• Provide operational support for the global study operating model, which encompasses business processes and service-provider operating frameworks.

• Enhance internal and external business process standards for Clinical Operations.

• Offer oversight and guidance to team members regarding contract escalations.

• Actively identify, manage risks, escalate, and resolve issues related to clinical site contracts.

• Create and regularly update functional SOPs, the Astellas Global Contract Negotiations Playbook, and other pertinent processes and tools.

• Serve as a liaison between site contract negotiators and designated legal partners to support global templates and processes and provide timely, strategic legal counsel.

⛳️ Requirements

• BA/BS degree with a minimum of 5 years of experience in pharmaceutical-related drug development or a directly equivalent background, or an advanced degree.

• Comprehensive contract management experience.

• Capability to manage competing priorities while fostering team development.

• Familiarity with clinical trial execution, including multi-center and global trials.

• In-depth knowledge of ICH/GCP guidelines and regulatory standards.

• Strong understanding of regulatory, legal, and data privacy challenges impacting the pharmaceutical sector, including GDPR as it pertains to core and country templates.

• Experience in the development and execution of process improvement initiatives.

• Excellent analytical problem-solving and decision-making capabilities.

• Ability to exercise sound judgment and deliver practical and constructive legal advice.

• Exceptional negotiation and communication skills, both written and verbal.

• Proficiency in conveying legal matters clearly and understandably.

• Outstanding interpersonal, written, and verbal communication skills.

• Administrative competence and computer proficiency.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.