Country Approval Specialist – FSP

🕒 June 5

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 45%

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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

• Prepare, review and coordinate local regulatory submissions 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 other partners to improve metrics and processes • Ensure standards are applied to Study Startup processes across projects • Review site essential 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 with 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 experience providing relevant knowledge, skills, and abilities • Understanding of the pharmaceutical industry • 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 • Willingness and ability to work in office, laboratory and/or clinical environments • Ability to comply with personal protective equipment requirements

🏖️ Benefits

• Award-winning learning and development programme • Flexible working culture • Work-life balance • Collaborative environment • Competitive salary • Health and well-being benefits package

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