Country Approval Associate

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p>Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation<br/>The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy.<br/><br/>What You'll Do:<br/>• Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy. <br/>• Support preparation, under guidance, of local MoH submissions, as applicable in <br/>• alignment with global submission strategy.<br/>• 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.<br/>• Achieve company’s target cycle times for site.<br/>• May have contact with investigators for submission related activities.<br/>• May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.<br/>• Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.<br/>• Assist in developing country specific Patient Information Sheet/Informed Consent form documents.<br/>• Assist with grant budgets(s) and payment schedules negotiations with sites.<br/>• Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner<br/>• Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.<br/>• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.<br/><br/>Education & Experience Requirements:<br/>• Bachelor's degree or equivalent and relevant formal academic / vocational qualification<br/>• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).<br/><br/>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. <br/><br/>Knowledge, Skills, Abilities: <br/>• Effective oral and written communication skills<br/>• Excellent interpersonal skills<br/>• Strong attention to detail and quality of documentation<br/>• Good negotiation skills<br/>• Good computer skills and the ability to learn appropriate software<br/>• Good English language and grammar skills<br/>• Basic medical/therapeutic area and medical terminology knowledge<br/>• Ability to work in a team environment or independently, under direction, as required<br/>• Basic organizational and planning skills<br/>• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.<br/><br/><br/>Working Conditions and Environment:<br/>• Work is performed in an office/ laboratory and/or a clinical environment. <br/>• Exposure to biological fluids with potential exposure to infectious organisms. <br/>• Exposure to electrical office equipment. <br/>• Personal protective equipment required such as protective eyewear, garments and gloves.<br/><br/>Why Join Us?<br/><br/>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.<br/><br/>Apply today to help us deliver tomorrow’s breakthroughs.<p></p><p></p><p></p><p></p>