Country Approval Specialist

🕒 October 15

🇲🇽 Mexico – 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 the global submission strategy • Provide local regulatory strategy advice to internal clients under guidance • Provide and coordinate project-specific local SIA services • 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 target cycle times for sites • Work with start-up CRAs to prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheets/Informed Consent forms • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activities according to agreed timelines • Enter and maintain trial status information for SIA activities in tracking databases • Prepare, set up, and maintain local country study files and filing processes • Maintain knowledge of applicable SOPs, directives, and current regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years • 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 knowledge of all applicable regional / national country regulatory guidelines and EC regulations • 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 • Basic organizational and planning skills • Ability to meet requirements through an equivalency of appropriate education, training and/or directly related experience

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