Country Approval Specialist

🔥 15 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 12%

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.

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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

• Prepare, review and coordinate local regulatory submissions, including MoH, EC and applicable special national applications, in alignment with the global submission strategy • Work directly with assigned sites on essential document collection and review • Partner with internal Study Startup teams, CROs, Clinical Operations teams and partners to improve metrics and processes • Ensure standards are applied to Study Startup processes across projects • Review site essential start-up documents, including ICF, FDF, 1572 and CVs • Identify potential site activation delays and escalate them appropriately • Track actions and communications with sites to achieve study and site timelines • Support resolution of escalated issues identified by CROs and Clinical Operations teams • Review site performance metrics and provide feedback to management • Ensure accuracy and completeness of the eTMF for assigned sites during start-up

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 2+ years of previous relevant experience • Understanding of the pharmaceutical industry, including clinical development and prescription drug distribution • Understanding of Clinical Trial Agreements, budgeting and fair market value principles • Knowledge of FDA and ICH-GCP guidelines for conducting clinical research • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and ability to learn appropriate software • Good English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, under direction, as required • Basic organizational and planning skills • Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations

🏖️ Benefits

• Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative work environment • Opportunities to share expertise and professional growth • Equal opportunity and affirmative action employment practices

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