Country Approval Associate

🕒 Outubro 22

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 21 dias.
• As vagas desta empresa costumam ser preenchidas em 26 dias.
• Sem salário divulgado.

Candidatar-se

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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

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