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A strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations.
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
Ensure the creation of high quality medical information content in a consistent and unbiased manner, while adhering to all applicable rules, regulations and SOPs. Develop and maintain material such as (Non)Standard Response Letters and Frequently Asked
Advise on and create early nonclinical safety screening strategy including data generation for the selection of relevant species to ensure smooth transition from discovery to IND-enabling studies. Design, development and oversight of nonclinical safety
In this global role, the Industrial Lead Drug Product will bring a strategic vision and leadership in the industrialization of our late-stage development and commercial products (NBE and NCE). You will develop cutting-edge industrialization strategies,
You will be responsible for the implementation, development and validation of high-quality qPCR, dPCR and NGS assays for use in clinical trials utilizing state of the art RNA and DNA technologies. Conduct laboratory procedures to support the development