Associate / Sr. Associate - Global Scientific Communications Regulatory

<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><span>At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.</span></p><p></p><p>Purpose:</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>The purpose of the Associate / Sr. Associate, GSC Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).</p><p>Primary Responsibilities:<span>  </span><span>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.</span></p><p></p><h2>1. <u>Content Strategy and Execution:  Document Preparation, Development and <span>Finalization/Document</span> Management</u></h2><ul><li><p>Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.</p></li><li><p>Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.</p></li><li><p>Conduct effective document initiation meeting to ensure authoring team alignment and understanding.</p></li><li><p>Build scientific-based rationale that support the purpose of more complex and/or strategic documents.</p></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, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.</li><li>Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.</li><li>Ensure and coordinate quality checks for accuracy.</li><li>Exhibit flexibility in moving across development and preparation of multiple document types.</li><li>Influence or negotiate change of timelines and content with other team members.</li><li>Work with internal and external experts to develop and prepare presentations.</li><li>As needed, may build and manage relationships with vendors/alliance partners.</li></ul><p></p><h2>2. <u>Project and Stakeholder management</u></h2><ul><li>Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.</li><li>Build/communicate credible writing project timelines.</li><li>Anticipate and mitigate risks to delivery.</li><li>Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.</li><li>Effectively communicate project status to stakeholders.</li></ul><p></p><h2>3. <u>Knowledge and Skills Development</u></h2><ul><li>Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).</li><li>Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.</li><li>Maintain and enhance knowledge of regulatory guidelines and publication guidelines.</li><li>Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory r