Thermo Fisher Scientific
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.
FSP Essential Document Pack Reviewer
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Thermo Fisher Scientific
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
• Review country essential documents for completeness, accuracy, and quality according to the Essential Document Compliance checklist • Review site essential documents for completeness, accuracy, and quality according to the Essential Document Compliance checklist • Notify the EDP Submitter by email of review outcomes, requested revisions, and corrected documents when deficiencies are identified • Review revised packs to confirm deficiencies were resolved and communicate the review outcome to the SSU Specialist • Track EDP review details in the applicable data tracking system • Maintain knowledge of SOPs, client SOPs/directives, and current regulatory guidelines
🎯 Requirements
• Bachelor's degree or previous experience comparable to 2+ years • Good English language written and oral communication skills, as well as local language where applicable • Good attention to detail, quality, editorial, and proofreading skills • Good interpersonal skills for effective teamwork • Good computer skills, including Microsoft Word, Excel, and PowerPoint, with ability to learn new technologies • Basic organizational, time management, and planning skills • Good negotiation skills • Ability to work independently with direction and exercise independent judgment • Ability to independently assess sponsor regulatory needs and produce compliant deliverables with project team members • Basic knowledge of global, regional, and national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management • Basic understanding of medical terminology, statistical concepts, and guidelines • Good analytical, investigative, and problem-solving skills • Ability to interpret data
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