Country Approval Associate

🕒 October 2

🇧🇷 Brazil – 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 under guidance, including MoH, EC and applicable special national/local applications • 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-related activities • Coordinate with internal functional departments to align site start-up activities with submission activities and agreed 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 Form documents as needed • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activity coordination according to agreed timelines • Enter and maintain trial status information for SIA activities in PPD tracking databases • Prepare, set up and maintain local country study files and filing processes according to PPD WPDs or applicable client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives and current applicable regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalent combination 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 • 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

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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