FSP Country Approval Specialist - fully client dedicated - Poland

Country Approval Specialist

Position Overview:

As a Country Approval Specialist at Thermo Fisher Scientific, you will play a crucial role in managing and preparing, reviewing, and coordinating country submissions. Your work will align with global submission strategies to activate investigative sites. This position requires a strong attention to detail, ownership of document accuracy, and the ability to hold yourself and others accountable.

Company Information:

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We enable our customers to make the world healthier, cleaner, and safer. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials, from study start-up through monitoring to study close-out, across commercial and government contracts. We help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Employment Type:

Full-time

Work Schedule:

Standard (Mon-Fri)

Environmental Conditions:

Office

Essential Functions:

• Regulatory Submissions: 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.
• Regulatory Advice: Provide, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients.
• Project Coordination: Provide project-specific local SIA services and coordination of these projects.
• Investigator Contact: May have contact with investigators for submission-related activities.
• Key Contact: Serve as the key contact at the country level for either Ethical or Regulatory submission-related activities.
• Cross-Functional Alignment: Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed-upon timelines. Ensure alignment of the submission process for sites and study with the critical path for site activation.
• Achieve Cycle Times: Achieve PPD’s target cycle times for site activation.
• Compliance Packages: May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• Document Development: May develop country-specific Patient Information Sheet/Informed Consent form documents.
• Budget Assistance: May assist with grant budget(s) and payment schedules negotiations with sites.
• Feasibility Support: Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Data Management: Enter and maintain trial status information relating to SIA activities onto PPD tracking databases accurately and in a timely manner.
• File Maintenance: Ensure local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
• SOP Adherence: Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Keys to Success:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job.
• In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• Effective oral and written communication skills.
• Excellent interpersonal skills.
• Strong attention to detail.

Salary:

• [Salary information not provided]

Location Type:

• [Location type not provided]