Expanded Access Manager – Post-Trial Access Specialist

🔥 11 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 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 • Assess feasibility, regulatory requirements, logistical plans and supply mechanisms for managed access • Partner with medical affairs, clinical operations and cross-functional stakeholders to deliver programs • Coordinate continuity of access for post-trial patients • Track program status, investigational product management, documents and data review activities in accordance with regulatory requirements and Good Manufacturing Practice • Manage vendors supporting program execution • Coordinate expanded access activities, document collection, filing, archiving, timelines and metrics • Provide program status and utilization updates • Support clinical supply planning and forecasting with CMC and other functional areas • Develop project materials and operational 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 and contribute to shared goals • 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 • Commitment to quality, compliance and continuous improvement

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume