Country Approval Specialist

at  Thermo Fisher Scientific

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.

REQUIREMENTS:

• > 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
  Our mission is to empower our customers to make the world a healthier, cleaner, and safer place. United as a team of over 100,000 colleagues, we embrace a shared set of values: Integrity, Intensity, Innovation, and Involvement. Together, we expedite research and provide support to patients in need. Join us at PPD, a part of Thermo Fisher Scientific, where we value diverse experiences, backgrounds, and viewpoints.
  We eagerly anticipate your application by 16 August 2024, as you embark on your journey with us!
  Apply today at http://jobs.thermofisher.com

• 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