
Regulatory Affairs Specialist
2 days ago
About Us:
TN Sweden is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.
We push the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
Our team in Solna, Sweden is seeking a highly skilled Regulatory and Start Up Specialist 2 (FSP) to join our team.
Job Description- Serve as Single Point of Contact (SPOC) for assigned studies, ensuring adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs, and work instructions.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Maintain internal systems, databases, and tracking tools with project specific information.
- Review site performance metrics and provide feedback to management.
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