Contracting – Walloon – Brabant Writing and monitoring risk assessments for impurities (eg, justification of specifications, elemental impurities risk assessments, extractables and leachables, degradation products, ICH M7-compliant evaluations, etc.) Planning, coordinating and monitoring the conduct of toxicology studies at contract research organizations in line with project timelines and budget Performing and monitoring toxicological risk assessments for various health-based exposure limits (PDEs, ADIs, etc.) Performing and monitoring environmental risk assessments (ERAs) and oversee the conduction of environmental studies to support such assessments. Authoring and/or reviewing reports, protocols, guidelines, guidances and SOPs and ensuring harmonized approaches with regard to the toxicological assessments Representing the non-clinical safety team in cross-functional meetings Providing support in the construction of CMC regulatory documents and positional papers (i.e., IND/NDA documents, MAA, etc.) Providing support to HS&E in the interpretation of toxicological study data produced in the context of REACH or CLP regulations Maintaining traceability of the assessments performed and the reports produced Maintaining adequate knowledge in the chemical and environmental field through conference attendance, training and benchmarking Good knowledge about non-clinical safety evaluation of starting materials, synthesis intermediates and impurities, degradation products, leachables and extractables and associated guidelines. Leadership skills: problem solving, diplomacy Professionalism skills: reliability and integrity Organizational skills: multi-tasking, prioritizing Team building skill: collaboration, commun... Benchmarking, Team Leadership, Evaluation, IND, Communication, Risk Analysis, Protocols, Critical thinking, Research, Budget, Projects, REACH, Regulation, Monitoring, Training, Contracts, Study Support, Planning, Writing, Health & Safety, Evaluation, Synthesis, Multi Tasking, Exposure, Reporting, Diplomacy, Organization Skills, Toxicology, Traceability, Conferences, Problem Management, Act with integrity, Team Building, CMC Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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