Senior Country Approval Specialist

🕒 Setembro 22

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

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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 local regulatory submissions in alignment with global submission strategy • Provide local regulatory strategy advice to internal clients • Develop and implement local submission strategy and provide technical expertise and coordination oversight • Serve as primary contact for investigators and local regulatory authorities • Ensure guidelines and processes are followed for internal, investigator and regulatory-authority communications • Act as key country-level contact for submission-related activities • Participate in submission, review and project team meetings • Coordinate site start-up activities with internal functional departments and align submission timelines with site activation critical paths • Achieve company target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activity in accordance with global project submission strategy • Develop country-specific Patient Information Sheet/Informed Consent documents • Assist with grant budgets and payment schedule negotiations with sites • Identify local out-of-scope contract activities and advise relevant functions • Support feasibility activities • Maintain accurate and current trial status information in the database • Oversee country study files and ensure compliance with PPD WPD or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines • Direct or mentor SIA individuals assigned to projects • Identify, resolve or escalate regulatory-process issues and anomalies

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalent combinations 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 • Good judgment and decision-making skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, with minimal supervision • Ability to mentor fellow SIA team members • Excellent team player with teambuilding skills • Basic organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations • Ability to work in an office/laboratory and/or clinical environment • Ability to use required personal protective equipment, including protective eyewear, garments and gloves

🏖️ Benefícios

• Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence • Work in a global team environment