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Country Approval Associated

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Country Approval Associated

Remote

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

  • • Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.
    • Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.
    • Coordinates, 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 submission process for sites and study are aligned to the critical path for site activation.
    • Achieves PPD's target cycle times for site.
    • May have contact with investigators for submission related activities.

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• May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
• Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• Assists in developing country specific Patient Information Sheet/Informed Consent form documents.
• Assists with grant budgets(s) and payment schedules negotiations with sites.
• Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely manner
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Job ID: ThermoFisher-R-01284910-1
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program