Expanded Access Manager – Post-Trial Access Specialist

🕒 September 25

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 14%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Set up and manage operational support for post-trial managed access programs from planning through close-out • Coordinate budgets, clinical trial management systems, vendor communications, investigational product stock and delivery, documents, agreements, contracts and correspondence • Collaborate with clinical study teams to assess feasibility, regulatory requirements, logistics and supply mechanisms • Partner with global and local medical affairs, clinical operations and cross-functional stakeholders • Coordinate day-to-day support to maintain continuity of access for post-trial patients • Track program status, investigational product management, documents and data review activities in line with regulatory requirements and Good Manufacturing Practice • Manage vendors supporting program execution • Coordinate expanded access activities, including document collection, filing, archiving, timelines and metrics • Provide program status and utilization updates to stakeholders • Support clinical supply planning and forecasting with CMC and other functional areas • Develop project materials and operational communication tools • Identify delivery issues and risks, coordinate corrective actions and communicate with stakeholders • Track milestones and timelines and contribute to program initiatives and process improvements

🎯 Requirements

• Bachelor’s degree in a scientific or clinical discipline, or equivalent relevant education and experience • At least 3 years of relevant experience in the pharmaceutical, biotechnology, clinical research or CRO industry • Direct experience in clinical research or managed access, for example as a study manager, Clinical Research Associate (CRA), project manager or in a comparable role • Working knowledge of compassionate use, early access or expanded access programs • Proven ability to work effectively in cross-functional teams • High level of integrity, accuracy and attention to detail • Strong organizational, prioritization and project management skills • Ability to deliver assignments on time and within budget • Strong problem-solving skills and sound judgment • Excellent written and verbal communication skills • Understanding of cross-functional responsibilities across Supply Chain, Regulatory, Pharmacovigilance, Legal, Medical Writing and local medical teams • Ability to coordinate multiple workstreams, stakeholders, vendors and deliverables • Ability to interpret operational and regulatory requirements and translate them into practical program plans • Ability to communicate risks, status, timelines and actions clearly to internal and external stakeholders • Commitment to quality, compliance and continuous improvement

🏖️ Benefits

• Full-time employment • Fully remote work arrangement • Standard Monday–Friday work schedule

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