水平: Mid-Senior level
工作类型: Contract
工作内容
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research approaching each opportunity with foresight, character, resilience and innovation.
We are currently partnered with a Global Biotech company specialized in complex biologicals, vaccines, plasma and plasma derived therapeutics and biotechnology.
You will be seconded directly to the sponsor company, working off their SOP’S as a fully submerged employee but with all the benefits that are offered through Advanced Clinical.
CMC Coordinator:
Main Responsibilities:
● Run small Expert Teams to compile Quality by Design and regulatory dossier information
● Compile Quality by Design information
● Compile CMC regulatory dossier information & PACMP protocols / reports
● Enable/direct internal department digital improvement initiatives encompassing: interactive training material, global portals, project reporting tools and dashboards, process flow data mapping.
● Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives
Education:
Pharma – Large or Small Molecules, MedTech
Experience:
● 5+ years experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (MedTech, electronics)
● Project coordination/leadership; enjoys leading teams to achieve quality results in a defined timeframe.
● QbD, process development, scale-up, technology transfer, process validation, CMC regulatory affairs, and / or MS&T
● A digital expertise with hands-on experience focused on advanced data management/ data processing/ data analytics in a life sciences area
● Have experience in interpreting, visualizing and communicating complex project data to facilitate collaborative decision-making driving cross-functional business outcomes
● Knowledge of regulatory activities and trends, experience with health authority, i.e., FDA, EMA, PDMA, is a definite plus
Location: Bern, Switzerland(Full-time, On-site)
Does that sound good?
If you’re thinking about whether it’s worth talking to us, let’s discuss how we can match up your goals for 2024 – your work, money, and personal ambitions with a company that really cares about keeping you motivated and appreciated every single day.
最后期限: 09-06-2024
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