Country Approval Associate

🔥 47 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – 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 Country Submissions under guidance and in alignment with global submission strategy • Support preparation of local Ministry of Health submissions, as applicable • Coordinate with internal functional departments to align site start-up activities and submission timelines • Ensure submission processes align with the critical path for site activation • Achieve company target cycle times for site activities • Contact investigators for submission-related activities as needed • Act as a country-level key contact for Ethical or Regulatory submission-related activities • Work with start-up CRAs to prepare regulatory compliance review packages • Assist in developing country-specific Patient Information Sheets and Informed Consent Forms • Assist with grant budgets and payment schedule negotiations with sites • Enter and maintain trial status information in company or client tracking databases • Prepare, set up and maintain local country study files and filing processes • Maintain knowledge of applicable PPD and client SOPs, directives and current regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 0 to 2 years of previous experience providing the knowledge, skills, and abilities to perform the job • 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 • In some cases, a combination of appropriate education, training and/or directly related experience may be considered sufficient

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Exposure to scientific innovation and excellence

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