Senior Manager CMC Dossier Strategy & Leadership (all genders) (permanent / full-time)

<h3>Unternehmensbeschreibung</h3><p>AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at <a href="https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.abbvie.com%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=ouW0EWAXMc6feS9YMhOrX50Xcr7u7esYey2hTi3aXEs%3D&amp;reserved=0">www.abbvie.com</a>. Follow @abbvie on <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftwitter.com%2Fabbvie&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=NB%2BpWyw5752pXI4BpdVAdYgTngw%2FY%2B2lxdjzuU62mik%3D&amp;reserved=0">X</a>, <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=pxrMl8T5PQl8HU8Xhph7jSamZXR%2Fqlh%2FTMIodipTPfs%3D&amp;reserved=0">Facebook</a>, <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=NwEPo8j8wQP42UyWxJuNXoHtRJW9IQ8qnjxx6705e8k%3D&amp;reserved=0">Instagram</a>, <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=%2Fz0FnNhXfkO2DHSZdZ2mGo6WQ1oEyKQTGDujo0hZDoQ%3D&amp;reserved=0">YouTube</a>, <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&amp;data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=eBnFZu5pxx5eG%2F%2BGHQXtjVOLh5olOf3QvjuzpAfYi0E%3D&amp;reserved=0">LinkedIn</a> and <a href="https://www.tiktok.com/@abbvie">Tik Tok</a>.</p><h3>Stellenbeschreibung</h3><p><strong>The job that makes possibilities real in patients' lives. And yours.</strong></p><p><strong>The job that helps you get ahead in life. Moving mountains together.</strong></p><p>Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!</p><p>Moving mountains together – as<strong> Senior Manager CMC Dossier Strategy &amp; Leadership (all genders) (permanent / full-time)</strong></p><p>This position ensures that global regulatory dossiers are aligned with current AbbVie’s CMC best practices.  The role works with CMC teams during the development of cutting-edge control strategies and influences in generating data packages that support the CMC control strategy.  The role authors narrative sections of CTDs to communicate a single, integrated strategy to health authorities, contributes to the preparation of regulatory query responses and briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content.   </p><p> </p><p><strong>Responsibilities</strong></p><ul><li>Embedded in the CMC team throughout development to collaborate on control strategy development and the planning of the data packages that will support the strategies.</li><li>Provides real-time input on source document preparation to ensure a submission-r