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Country Approval Associate

Country Approval Associate

Thermo Fisher ScientificNorway
30+ dager siden
Jobbtype
  • Fulltid
Jobbeskrivelse

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 :

  • CAA : 0 - 2 years related experience or equivalent combination of education, training, & experience
  • 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!