Associate/Sr. Associate - Global Scientific Communications - CMC

<p>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.</p><p></p><p>At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 45,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.</p><p><br/>Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across <span>60 nationalities</span> who deliver innovative solutions that add value across a variety of <span>Business Service</span> functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little <span>Island, complete</span> with flexible hybrid working options, healthcare, pension and life <span>assurance benefits,</span> subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ <br/>wellbeing initiatives are just some of the holistic benefits that enhance the <span>career experience</span> for our colleagues.</p><p><br/>Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural <span>backgrounds, generations,</span> sexuality, visible and invisible disabilities and gender, with four <span>pillars: EnAble,</span> embRACE, LGBTQ+ &amp; Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access <span>Lilly initiative</span> to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability <span>confident culture</span> both at Eli Lilly Cork and beyond. </p><p><br/>Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!</p><p></p><p></p><p>Are you interested in Chemistry, Manufacturing and Controls (CMC) drug development, technical writing, and leading cross functional teams?</p><p></p><p>The purpose of the Scientific Communications Associate – CMC Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of CMC regulatory documents intended for regulatory audiences.</p><p></p><p>Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.</p><p></p><p><b>Primary Responsibilities</b>:  This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.</p><p></p><p><b>Responsibilities:</b></p><p></p><p>1.<u>Content Strategy: Document Preparation, Development and <span>Finalization/Document</span> Management</u></p><ul><li>Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects that supports and implements the regulatory submission strategy developed by GRA- scientists.</li><li>Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate and complete <span>the CMC regulatory documents. </span></li><li>Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding. </li><li>Build scientific-based rationale that support the purpose of more complex and/or strategic documents.</li><li>Ensure data are presented in a clear, complete, accurate, and concise manner.</li><li>Ensure that key data, statements and conclusions are consistent across related documents including module summaries. Ensure that statemen