Country Approval Specialist Job at Thermo Fisher Scientific

Thermo Fisher Scientific is hiring for the role of Country Approval Specialist!

Responsibilities of the Candidate:

• Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provide under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provide project-specific local SIA services and coordination of these projects
• Coordinate under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of the submission process for sites and study is aligned to the critical path for site activation.
• Achieve PPD’s target cycle times for the site.
• Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• Develop country-specific Patient Information Sheet/Informed Consent form documents.
• Assist with grant budgets(s) and payment schedule negotiations with sites.
• Support the coordination of feasibility activities, as required, by agreed timelines.
• Enter and maintain trial status information relating to SIA activities onto PPD 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.

Requirements:

• Effective oral and written communication skills.
• Excellent interpersonal skills.
• Strong attention to detail and quality of documentation.
• Good negotiation skills.
• Good computer skills and the ability to learn appropriate software.
• Good English language and grammar skills.
• Basic medical/therapeutic area and medical terminology knowledge.
• Ability to work in a team environment or independently, under direction, as required.
• Basic organizational and planning skills.
• Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations