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Regulatory Affairs Scientist (Contract)

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4EEBC1C3ABA954AE82E18E28205B6662
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Senior Principal Scientist (Study Monitor) Preclinical Safety

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Senior Principal Scientist (Study Monitor) Preclinical Safety

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NovartisSenior Principal Scientist (Study Monitor) Preclinical SafetyJoin to apply for the

Senior Principal Scientist (Study Monitor) Preclinical Safety

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NovartisThe Preclinical Safety (PCS) department within the Biomedical Research (BR) - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance.The Preclinical Safety (PCS) department within the Biomedical Research (BR) - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance.As a Scientific Study monitor, you will join our PCS team to oversee non-clinical research activities for multiple projects across multiple disease areas for in-vivo toxicity and /or in-vitro screening toxicity studies conducted at our CRO partner sites as per the internal strategy and international standards, acting as the primary scientific contact for the Study Director.Formulates and leads/co-leads novel projects with team or enables matrix collaboration on project/technology solutions to achieve creative results for impact on BR goals. Generates innovative ideas within own team and/or project team/functional community to meet new technical requirements and/or answer project key scientific/technical/development questions. Establishes target dates and priorities to enable data-driven advancements in project teams, within own team, and with collaborators, or within functional community.The Study Monitor is appointed to each outsourced preclinical study based on relevant technical expertise, designated disease area and/or scientific background knowledge and acts as the primary scientific contact for the Study Director at the Contract Research Organization (CRO).The Study Monitor should ensure that the study is compliant with the appropriate GLP regulations, Novartis animal welfare policies, CRO in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.Resolution of study related issues, liaisons with internal experts and informing the appropriate people in a timely manner is pivotal to the performance of this role. Works closely with the PCS-Operations and PCS Project Team Member (PTM) to formulate a project outsourcing strategy.Has a working knowledge of HA regulations (Swiss medic, OECD, FDA) to support conduct of GLP compliant toxicology studies.May be PCS part-time PTMPhD or MVSc/MS/M.In-depth knowledge of toxicology assays in early development, Safety pharmacology and genotoxicityExcellent communicators, strong team players and have a high level of logistical/planning ability.Registration and certification with one of the International Toxicology registers.Why Novartis:

Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. Commitment To Diversity And InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams'' representative of the patients and communities we serve.Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:Read our handbook to learn about all the ways well help you thrive personally and professionally:Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Join our Novartis Network:

Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:Read our handbook to learn about all the ways well help you thrive personally and professionally:

Employment type

Full-time

Job function

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