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Country Approval Specialist
2 months ago
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:
> 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 skillsOur 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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