Principal Country Approval Specialist (Startup Lead)

Work Schedule Standard Office Hours (40/wk) 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. Discover Impactful Work: Manages the preparation, review and coordination of Country Submissions in line with global submission strategy. A day in the Life: Prepares, reviews and coordinates 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. Provides local regulatory strategy advice (MoH & EC) to internal clients. Provides project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments. Serves 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. Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner. Acts as a key-contact at country level for all submission-related activities. Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings. Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Achieves PPD’s target cycle times for site activations. Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. Develops country specific Patient Information Sheet/Informed Consent form documents. May assist with grant budgets(s) and payment schedules negotiations with sites. Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. Coordinates country study files and ensures that they meet PPD WPD’s or client SOP’s. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. Advises/mentors other SIA individuals assigned to support projects of responsibility, as appropriate. Prepares and maintains country master document templates and other PPD regulatory intelligence systems, as may be required and assigned. Keys to Success: Education Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Experience 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 digital literacy and the ability to learn appropriate software Good English 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 direction, as required Ability to mentor fellow SIA team members in a positive and effective manner Standout colleague with excellent teambuilding skills Good organizational and planning skills Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations Physical Requirements / Work Environment Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. 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