Country Approval Associate

🕒 October 22

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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.Why this score:

• Open for 22 days.
• Jobs at this company usually fill in 26 days.
• No salary listed.

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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 Country Submissions under guidance and in alignment with global submission strategy • Support preparation of local Ministry of Health submissions • Coordinate with internal functional departments on site start-up activities and submission timelines • Ensure submission processes align with the critical path for site activation • Achieve company target cycle times for sites • Contact investigators for submission-related activities as needed • Act as country-level key contact for ethical or regulatory submission activities as needed • 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 tracking databases • Prepare, set up and maintain local country study files and filing processes • Maintain knowledge of PPD, client SOPs/directives and current regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 0 to 2 years • 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 regulatory guidelines and EC regulations • Exposure to biological fluids with potential exposure to infectious organisms • Ability to use required personal protective equipment

🏖️ Benefits

• Collaboration and development opportunities • Work in a global team environment • Personal protective equipment such as protective eyewear, garments and gloves

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