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von: Innovative Medicines
As part of the Drug Product Development Scientific Office you will provide strategic and scientific guidance on integrating new Biologics drug product-related technologies (such as new delivery technologies, new formulation approaches, and new development approaches, e.g. modeling approaches) into CMC projects in collaboration with key stakeholders. You will also support CMC teams in compiling dossiers, drive engagement with industry consortia and health authorities to enable new technologies implementation. modeling approaches) into CMC projects in collaboration with key stakeholders.
~ Promote a comprehensive approach to drug product development that focuses on the needs of patients and payers while integrating new technologies (pharmaceutical / in-silico) in line with Health Authorities expectations .
~ Liaise with key stakeholders, including Biomedical Research, Global Program Teams, Devices and Primary Packaging, Regulatory CMC, Quality, and Commercial Manufacturing sites, to encourage them to integrate new technologies into our Biologics product while ensuring their needs for a patient-centric product are met .
~ Support / drive interactions with health authorities through participation on briefing packages
~ Proactively identify, lead/propose solution-oriented plan s to resolve scientific drug product development challenges/barriers.
~ Relevant experience of developing and implementing strategies of patient-centered science related work
~ Outstanding i nfluencing skills, leading without authority, excellent presentation and communication skills towards different internal and external stakeholders ( senior management, health authorities), outstanding ability to deal with ambiguity, combined with d emonstrating strong business acumen
Why Novartis: Helping people with disease and their families takes more than innovative science.
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