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Specialist/Snr Specialist Study Start Up and Regulatory Affairs

🕒 9 days ago
Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review

📜 Description

  • Medicine moves forward here. So will you.
  • Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational
  • If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.
  • The Senior Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related
  • to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory
  • compliance, and serves as a key liaison between internal teams, clients, and external stakeholders

🛠️ Requirements

  • Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience
  • Minimum 4 years within pharmaceutical or CRO industry or Regulatory body
  • Good knowledge of ICH GCP and national regulations for territories of competency
  • Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring compliance and serving as a liaison among teams, clients, and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring regulatory compliance and serving as a liaison among teams and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring compliance and serving as a liaison between teams and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring compliance and serving as a liaison among teams and stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review
🕒 9 days ago

The Senior Specialist in Study Start Up and Regulatory Affairs leads site initiation readiness, ensuring regulatory compliance and coordinating activities across internal teams and external stakeholders.

Regulatory ComplianceClinical ResearchStudy Start-upDocumentation Review

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