Clinical Submissions Specialist - Norway Start-Up Focus

Resourcing Life Science Ltd.; Norway; On-site; NOK 700,000 - 900,000; Full time

Job summary

Resourcing Life Science Ltd. is seeking a Start up Specialist for an office-based role in Norway. You will manage CA & EC submissions, maintain up-to-date GCP/ICH knowledge, and coordinate translations of essential documents for submissions.

You will supervise study conduct in line with GCP and applicable laws, collaborate with cross-functional teams, and ensure timely regulatory milestones for early-phase to late-phase clinical studies.

Qualifications

• Bachelor degree in life sciences.
• Minimum 2 years in EC & CA submissions within a CRO/Pharma/Biotech in Norway.
• Experience in clinical studies phase II-III.
• Excellent communication skills; fluent in Swedish & Norwegian.

Responsibilities

• Submit CA & Ethics Committee (EC) submissions.
• Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
• Translate and coordinate translations for documents required for submissions.
• Supervise study conduct according to GCP requirements and applicable laws.

Skills

Excellent communication skills

Swedish language

Norwegian language

GCP knowledge

Education

Bachelor degree in life sciences

Job description

Resourcing Life Science Ltd. is seeking a Start up Specialist for an office-based role in Norway. You will manage CA & EC submissions, maintain up-to-date GCP/ICH knowledge, and coordinate translations of essential documents for submissions.

You will supervise study conduct in line with GCP and applicable laws, collaborate with cross-functional teams, and ensure timely regulatory milestones for early-phase to late-phase clinical studies.