FSP Country Approval Specialist

🔥 5 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 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.

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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 • Provide local regulatory strategy advice to internal clients under guidance • Provide and coordinate project-specific local SIA services • Contact investigators for submission-related activities when needed • Serve as the country-level key contact for ethical or regulatory submission activities • Coordinate with internal functional departments so site start-up activities align 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 and Informed Consent Forms when needed • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activities according to agreed timelines • Enter and maintain trial status information for SIA activities in PPD tracking databases • Prepare, establish and maintain local country study files and filing processes according to PPD WPDs or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives and applicable regulatory guidelines • Work in an office/laboratory and/or clinical environment with potential exposure to biological fluids, infectious organisms and electrical office equipment

🎯 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 • Personal protective equipment required, such as protective eyewear, garments and gloves

🏖️ Benefits

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

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