Prepare, review and coordinate regulatory submissions ((Norwegian Medical Products Agency (RA), Ethics Committee (EC), EU CTR part II submissions), additional national applications if applicable, 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

Requirements :

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!