Country Approval Specialist

🕒 October 8

🇦🇷 Argentina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 10%

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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 local regulatory submissions in alignment with global submission strategy • Provide local regulatory strategy advice to internal clients under guidance • Provide project-specific local SIA services and coordinate these projects • Contact investigators for submission-related activities as needed • Serve as country-level key contact for ethical or regulatory submission activities • 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 PPD target cycle times for sites • Work with start-up CRAs to prepare regulatory compliance review packages as applicable • Develop country-specific Patient Information Sheet/Informed Consent documents as needed • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activities according to agreed timelines • Enter and maintain trial status information relating to SIA activities in PPD tracking databases • Prepare, set up and maintain local country study files and filing processes • Maintain knowledge of PPD SOPs, client SOPs/directives and applicable regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 2+ years • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • 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 • Ability to work in Argentina

🏖️ Benefits

• Fully remote work arrangement

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