As a Medical Writer you are part of our Miltenyi biomedicine business and within the Clinical Development team. * You lead the development, authoring, and submission of regulatory documents (e.g., CTD modules, clinical study reports, investigator brochures, INDs/IMPDs, NDAs/MAAs, and briefing documents). * You are actively leading technically Medical Writers, potentially participate in recruiting and onboarding junior writers, providing guidance and reviewing documents prepared by internal teams or external vendors to ensure quality and regulatory compliance. * You have a strong track record of authoring and managing key regulatory submission documents; experience with MAA/BLA submissions is a plus.
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