FSP Country Approval Associate

Thermo Fisher ScientificRemote, North Carolina, USAremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy. What You'll Do: • 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. Education & Experience 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). 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. Knowledge, Skills, Abilities: • 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. Working Conditions and Environment: • 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. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.

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