You are a hands-on Medical Expert responsible for executing clinical-scientific activities across the product lifecycle, focussed on the development of high-quality regulatory documentation (CTD) and support of global submissions and lifecycle management. * Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other lifecycle documents - At our location in Wedel near Hamburg, we are looking for a Medical Expert – Clinical Science (all genders). * Ensure robust benefit–risk justification, regulatory alignment and high-quality documentation * Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs
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