Principal Country Approval Specialist

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. Join Us as a Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation The Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy. What You'll Do: 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. Provide local regulatory strategy advice (MoH & EC) to internal clients. Provide project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments. 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. 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. Act as a key-contact at country level for all submission-related activities. Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings. 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. Achieves company’s target cycle times for site activations. Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. Develop country specific Patient Information Sheet/Informed Consent form documents. May assist with grant budgets(s) and payment schedules negotiations with sites. Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions. Support the coordination of feasibility activities, as required, in accordance with agreed timelines. Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s. Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. Direct/mentor other SIA individuals assigned to support projects of responsibility, as appropriate. Prepare and maintain country master document templates and other regulatory intelligence systems, as may be required and assigned. 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 8+ 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 Solid negotiation skills Good computer skills and the ability to learn appropriate software Good English and Polish language and grammar skills Good judgment and decision-making skills Basic medical/therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, with minimal supervision, as required Ability to mentor fellow SIA team members in a positive and effective manner Excellent team player with teambuilding skills Good organizational and planning skills Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations Why to join us At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development program, ensuring you reach your potential. Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Apply today to help us deliver tomorrow’s breakthrough.