Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. * 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). * As an expert in your field, you possess in-depth knowledge of ICH guidelines and data protection laws relevant to medical writing and you are experienced in setting up standards and processes. * 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.
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