Job Information
ThermoFisher Scientific Senior/Country Approval Specialist in Remote, Bulgaria
Work Schedule
Other
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.
Our Clinical Operations team is rapidly growing and we are currently looking for a Country Approval Specialist (Submissions Specialist) who will be responsible for pulling regulatory Country Submissions together in order to activate investigative sites. If you have a strong attention to detail, take ownership of the accuracy of these documents while holding yourself and others accountable, then this role is the right for you. This role could be home or office based in Bulgaria.
As a Country Approval Specialist, you will:
Prepare, review and coordinate, under guidance, 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, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
Provide project specific local start-up services and coordination of these projects
May have contact with investigators for submission related activities
Key-contact at country level for either Ethical or Regulatory submission-related activities
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 CRG’s target cycle times for site activation
May work with CRA(s) to prepare the regulatory compliance review packages, as applicable
May develop country specific Patient Information Sheet/Informed Consent form documents
May assist with grant budgets(s) and payment schedules negotiations with sites
Support the coordination of feasibility activities, as required, in accordance with agreed timelines
Enter and maintain trial status information relating to start-up activities onto internal 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 CRG WPDs or applicable client SOPs
Maintains knowledge of and understand CRG SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
Qualifications - External
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous Start Up experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Knowledge, Skills, and Abilities:
Effective communication skills (verbal and written) in English
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
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
Why Join Us?
We hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both expertly and personally throughout your career, and therefore will benefit from an award-winning learning and development programme, ensuring you reach your potential.
What We Offer:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.