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.Position Overview:
As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy to activate investigative sites. You will ensure the accuracy of these documents, taking ownership of your work and holding yourself and others accountable.Essential Functions:
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 licenses) in alignment with global submission strategy.Provide local regulatory strategy advice (MoH & / or EC) to internal clients.Coordinate with internal departments to ensure site start-up activities are aligned with submission timelines.Ensure alignment of submission processes with the critical path for site activation and achieve target cycle times.Assist with developing country-specific Patient Information Sheets / Informed Consent forms.Support feasibility activities and maintain trial status information accurately in tracking databases.Maintain local study files and ensure compliance with SOPs and regulatory guidelines.Education and Experience:
Bachelor's degree or equivalent, with relevant experience in regulatory submissions or clinical trial coordination. Equivalent combinations of education and experience may be considered.Knowledge, Skills, Abilities:
Effective communication skills, both oral and written.Interpersonal skills and attention to detail.Computer literacy and ability to learn new software.Basic medical terminology and understanding of regulatory guidelines.Ability to work independently or as part of a team.Why Join Us:
We value professional and personal growth, offering award-winning development programs. Our benefits focus on health and well-being, with a flexible work culture that promotes work-life balance. Join a global organization with a local feel, driven by our shared values:
Integrity, Intensity, Innovation, and Involvement.Apply today! Thermo Fisher Scientific is an Equal Opportunity Employer and values diversity in the workplace.
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