This role is with Thermo Fisher Scientific, an inclusive employer and a member of the global LGBTQ+ business community.

Please note that you should not contact the recruiter directly.

Work Schedule and Environment:
Standard (Monday to Friday)
Office Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that has a positive impact on a global scale.

Our Mission:
We enable our customers to make the world healthier, cleaner, and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

Our Work:
Clinical trials are conducted in 100+ countries, and we're developing novel frameworks for clinical research through our PPD clinical research portfolio.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Key Responsibilities:
We help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a Country Approval Specialist, you will participate in the management and preparation, review, and coordination of Country Submissions in line with global submission strategy to activate investigative sites.

Essential Functions:

1. Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.
2. Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
3. Provides project-specific local SIA services and coordination of these projects.
4. May have contact with investigators for submission-related activities.
5. Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
6. Achieves PPD's target cycle times for site.
7. May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
8. May develop country-specific Patient Information Sheet/Informed Consent form documents.
9. May assist with grant budgets and payment schedules negotiations with sites.
10. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
11. Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
12. Ensures the local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
13. Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.