FSP Country Approval Specialist II

🔥 5 minutes ago

🌐 Denmark, Norway, +1 more countries – Remote

🇩🇰 Denmark – Remote 🇳🇴 Norway – Remote 🇸🇪 Sweden – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 15%

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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 Ministry of Health, Ethics Committee and applicable special national applications, in alignment with the global submission strategy • Provide local regulatory strategy advice to internal clients under guidance • Provide and coordinate project-specific local SIA services • Communicate with investigators regarding submission-related activities when required • Serve as the country-level key contact for ethical or regulatory submission activities • Coordinate with internal functional departments to align site start-up activities with submission activities and agreed timelines • Ensure submission processes for sites and studies align with the critical path for site activation • Achieve PPD target cycle times for sites • Work with start-up CRAs to prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheets/Informed Consent forms when required • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activity coordination in accordance with agreed timelines • Enter and maintain trial status information for SIA activities in PPD tracking databases • Prepare, set up and maintain local country study files and filing processes according to PPD WPDs or applicable client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives and current applicable regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalent combination of appropriate education, training and/or directly related experience may be considered • 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 • Ability to work in an office/laboratory and/or clinical environment • Ability to work around biological fluids and potentially infectious organisms • Ability to use required personal protective equipment, including protective eyewear, garments and gloves

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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