Senior Country Approval Specialist

<p style="text-align:left"><b>Work Schedule</b></p>Standard Office Hours (40/wk)<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><p>Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation<br />The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.<br /><br />What You&#39;ll Do:<br />• Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.<br />• Provide local regulatory strategy advice (MoH &amp;/or EC) to internal clients.<br />• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.<br />• Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.<br />• Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.<br />• Act as a key-contact at country level for all submission-related activities.<br />• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.<br />• Coordinate 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 activations.<br />• Prepare the regulatory compliance review packages, as applicable.<br />• Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.<br />• Develop country specific Patient Information Sheet/Informed Consent form documents.<br />• May assist with grant budgets(s) and payment schedules negotiations with sites.<br />• Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.<br />• Support the coordination of feasibility activities, as required, in accordance with agreed timelines.<br />• Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.<br />• Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s.<br />• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.<br />• Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate<br />• Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.<br /><br />Education &amp; Experience Requirements:<br />• Bachelor&#39;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 5&#43; 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 />• Good judgment and decision-making skills<br />• Basic medical/therapeutic area and medical terminology knowledge<br />• Ability to work in a team environment or independently, with minimal supervision, as required<br />• Ability to mentor fellow SIA team members in a positive and effective manner<br />• Excellent team player with teambuilding skills<br />• Basic organizational and planning skills<br />• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations<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></p>