Long Description

• Member of projects teams (drug discovery and development) to provide support and feedback about studies status as expert on non-clinical toxicology 
• Planning and monitoring of outsourced toxicity studies in the research and development phases ensuring compliance with GLP, regulatory requirement and internal SOPs
• Acting as contact for CROs and/or Providers
• Study documents: Protocols and Reports review/finalization
• Liaising with relevant contributors and accountable team members to ensure timely production and review of regulatory documentation (IB, IND, CTD, NDA etc.).
• Preclinical support for Due Diligence 
• Interaction with regulatory authorities (EU, US and RofW)
• Study budget: contributing to budget planning with the relevant persons in charge of budget by providing cost estimation, forecast & budget revision and reconciliation 

Experience required: At least 5 years in this position in pharmaceutical companies 

Education: Scientific Degree 

Languages: English fluent

Technical Skills

• Knowledge of drug development process 
• Knowledge of toxicity database
• Knowledge of national and international guidelines
• Knowledge of biologic drugs development will be appreciated