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vor 4 Wochen


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I'm partnered with a a pioneering biopharmaceutical company advancing personalised cell & gene therapies for life-threatening diseases. This role is an opportunity to be a part of the future of cell and gene therapy working with an innovation focused clinical development team. Responsibilities: Lead the creation, authoring, review and finalisation of clinical and regulatory documentation (CTD modules, clinical study reports, investigator brochures, INDs/IMPDs, NDAs/MAAs, briefing documents)Ensure all documents are scientifically robust, strategically aligned, and fully compliant with global regulatory standardsManage document timelines, orchestration of internal reviews, on-time delivery and alignment across cross-functional teams (clinical operations, regulatory affairs, biostatistics, safety)Mentor and oversee a team of medical writers, participate in recruiting and onboarding junior writers, and ensure quality and regulatory integrity across deliverablesYour ProfileRelevant life science degree 5+ years of experience in medical/regulatory writing Comprehensive knowledge of ICH guidelines, global regulatory requirements and standards for QMS in writing and document controlProven track record in authoring key submission documents (MAA/BLA/CTA) and experience in advanced therapy medicinal products, oncology/hematology or autoimmune domains is highly advantageousLeadership experience including mentoring, team-management in medical writing or QARA rolesExcellent project management skills, ability to translate complex scientific data into clear regulatory narratives, fluent in English and comfortable working in a fast-paced international environmentFor more information please contact ajenkins@barringtonjames.com


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