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We are seeking a highly skilled Country Approval Specialist to join our team at Thermo Fisher Scientific. As a key member of our global submission team, you will play a critical role in ensuring the successful approval of our clinical trials in various countries.
Key Responsibilities- Prepare and review local EC submissions in alignment with our global submission strategy.
- Support the preparation of local MoH submissions, as applicable, in alignment with our global submission strategy.
- Coordinate with internal functional departments to ensure site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
- Ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieve our target cycle times for site activation.
- May have contact with investigators for submission-related activities.
- May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
- Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- Assist in developing country-specific Patient Information Sheet/Informed Consent form documents.
- Assist with grant budgets and payment schedules negotiations with sites.
- Enter and maintain trial status information relating to SIA activities onto PPD, or client (where contracted) 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 PPD WPDs or applicable client SOPs.
- Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
To be successful in this role, you will need to have a strong understanding of regulatory guidelines and submission processes. You will also need to be able to work effectively in a team environment and communicate complex information to stakeholders.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
