
Country Approval Specialist
3 days ago
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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 & EC) to internal clients.
Have contact with investigators during the 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 submission activities and mutually agreed upon timelines; ensure alignment of the submission process for sites and studies 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 accurately and timely.
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:
- > 1 year related experience or equivalent combination of education, training, & experience.
- Effective oral and written 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
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