Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Are you a highly motivated individual with a passion for clinical trials? Do you thrive in a collaborative environment, where your work can have a significant impact on scientific advancements? If so, we have an outstanding opportunity for you!

Thermo Fisher Scientific Inc. is seeking a Country Approval Specialist to join our phenomenal team in Norway, working home-based. As a clinical trial start-up role, you will exhibit work behaviors that contribute to accelerating research, solving complex project challenges, and driving innovation. This is your chance to join a company that values diversity and actively fosters an inclusive culture.

• Prepare, review and coordinate regulatory submissions ((Norwegian Medical Products Agency (RA), Ethics Committee (EC), EU CTR part II submissions), additional national applications if applicable, e.g. gene therapy approvals, IVDR/MDR) in alignment with global submission strategy.
• Provide local regulatory strategy advice (RA &/or EC) to internal clients
• Have contact with investigators during start up period
• Key-contact at country level for either Ethical or Regulatory submission-related activities
• Coordinate with internal functional departments to ensure various site tasks 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 (RCR) packages, as applicable
• Develop country specific Patient Information Sheet/Informed Consent form documents
• Enter and maintain trial status information relating to start up activities in systems/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

• > 1 year related experience or equivalent combination of education, training, & experiencee
• Effective oral and written communication skills
• Excellent communication skills
• Strong attention to detail and quality of documentation
• Good digital literacy and the ability to learn appropriate software
• Proficiency in English and Norwegian
• Ability to work in a team or independently, under direction, as required
• Good organizational and planning skills