As a Medical Writer you are part of our Miltenyi biomedicine business and within the Clinical Development team. * Your profile is rounded by a solid understanding of drug development and regulatory frameworks (ICH, EMA, FDA), excellent project management skills, and the ability to communicate complex scientific data clearly in English. You will be responsible for the development and oversight of clinical and regulatory documents that support global drug development programs, including preparation, development, review, revision and finalization of clinical documents for submission to regulatory authorities. * 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 hold a degree in life sciences (or equivalent); an advanced degree (e.g., PhD or Master's) is ...
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