Start up Specialist Norway

Resourcing Life Science Ltd.

Norway

On-site

NOK 700,000 - 900,000

Full time

13 days ago

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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

Company Description

Our client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Start up Specialist office based in Norway.

Job Overview

Responsible for CA & Ethics Committee (EC) submission
Keep up to date knowledge of GCP and ICH Guidelines for clinical research.
Translation and co-ordination of translations for documents required for submissions.
Supervising study conduct according to GCP requirements and all applicable laws.

Key Requirements