Senior Specialist: Study Start-Up

02 set - Roma
Ergomed Group

Ergomed Group in Italy seeks a Senior Specialist, Study Start Up and Regulatory Affairs to lead activities ensuring site initiation readiness across studies. You will provide subject matter expertise, manage regulatory submissions, and liaise with internal teams, clients and external stakeholders.
Key duties include delivering regulatory milestones, drafting and reviewing essential documents, site agreements, translations, and ensuring compliance with ICH-GCP and country-specific requirements.

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