Country Approval Associate

at  Thermo Fisher Scientific

COUNTRY APPROVAL ASSOCIATE / COUNTRY APPROVAL SPECIALIST

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 Clinical Operations team in Denmark is expanding and we are currently looking for a Country Approval Associate (CAA) / Country Approval Specialist (CAS) who will be working from our office in Copenhagen or home based anywhere in Denmark.

Country Approval Associate (CAA) / Country Approval Specialist (CAS), you will:

• Prepare, review and coordinate, under guidance, local regulatory submissions ((Danish Medicines Agency (MoH), Ethics Committee (EC) and EU CTR part II submissions), additional special national local applications if applicable, e.g. gene therapy approvals, IVDR/MDR) 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
• 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; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
• Prepare the regulatory compliance review packages, as applicable
• Develop country specific Patient Information Sheet/Informed Consent form documents
• Enter and maintain trial status information relating to start up activities onto PPD clinical research services 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 internal or applicable client SOPs
• Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Please refer the Job description for details