Country Approval Specialist

🔥 38 minutes ago

🇵🇭 Philippines – 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 when required • Act as country-level key contact for ethical or regulatory submission-related activities • Coordinate with internal functional departments to align site start-up activities and submission timelines • Ensure submission processes for sites and studies align with the critical path for site activation • Achieve PPD’s target cycle times for sites • Work with start-up CRAs to prepare regulatory compliance review packages when applicable • Develop country-specific Patient Information Sheet/Informed Consent Form documents when required • Assist with grant budgets and payment schedule negotiations with sites • Support feasibility activities in accordance with 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 applicable regulatory guidelines

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the 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 all applicable regional / national country regulatory guidelines and EC regulations • Work is performed in an office/ laboratory and/or a clinical environment • Exposure to biological fluids with potential exposure to infectious organisms • Exposure to electrical office equipment • Personal protective equipment required such as protective eyewear, garments and gloves

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