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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
Development and leading execution of the medical strategy that informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy. Contribution to cross-functional stakeholder teams in shaping
In this role, you will coordinate and track regulatory submissions, partnering with the Regulatory Lead to prepare high-quality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to