Country Approval Associate

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🔥 2 hours ago

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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, under guidance and local EC submissions in alignment with global submission strategy. • Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. • Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. • Achieve company’s target cycle times for site. • May have contact with investigators for submission related activities. • May act as a key-contact at country level for either Ethical or Regulatory submission-related activities. • Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. • Assist in developing country specific Patient Information Sheet/Informed Consent form documents. • Assist with grant budgets(s) and payment schedules negotiations with sites. • Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner. • Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

🎯 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 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 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.

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities during application and interview process. • Equal Opportunity Employment ensuring consideration for all without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.