FSP Country Approval Associate

🔥 18 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Associate

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 Country Submissions under guidance and in alignment with global submission strategy • Support preparation of local Ministry of Health submissions • Coordinate internal functional departments and site start-up activities with 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 • Prepare regulatory compliance review packages with start-up CRAs • Develop country-specific Patient Information Sheet/Informed Consent documents • 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 and client SOPs, directives and applicable regulatory guidelines

🎯 Requirements

• 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 country regulatory guidelines and EC regulations • Work in an office/laboratory and/or clinical environment • Ability to use required personal protective equipment

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Exposure to innovation and scientific excellence