Rights

i-Pharm Consulting Ltd is recruiting on behalf of client in Oslo

i-Pharm Consulting is recruiting for a CMC Regulatory Affairs Manager to strengthen the regulatory team in maintaining CMC dossier documentation in a fast growing biotechnology company in the Nordic Region.

Job Responsibilities:

• Compiling, reviewing, updating and maintaining the drug dossier documentation for regulatory submissions.
• Being up-to-date with all regulatory requirements and secure the right implementation across the teams.

Skills/Requirements:

• Life Science/Pharmacy degree.
• 3+ year of CMC regulatory experience.
• Desirable experience with submissions to EMA and FDA.

inVentiv Health Clinical is recruiting on behalf of client

Here at inVentiv Health Clinical we are currently recruiting for a Clinical Research Associate II or Sr CRA to be based in Norway.

As a Clinical Research Associate you will be at the forefront of the clinical trials practice. As a member of our Clinical Research Team, you will reflect its unique characteristics and help world-class companies to ensure the right size and custom fit for their trial needs. This is an excellent opportunity enabling you to take your careers and skills to the next level working for the world's largest healthcare clients.

Responsibilities:

• Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 - 50% travel) for GCP compliance according to inVentiv Health SOPs and/or client guidelines
• Recruit investigators for participation in clinical trials
• Negotiate study budgets with investigators