Ciara Kenneally

Sr Associate - Regulatory - Global Scientific Communications @Eli Lilly and Company

Cork, IE

Content Strategy and Execution: Document Preparation, Development, and Finalization/Document Management- Collect and evaluate data, information, and input from multiple functions and sources to create a cohesive content strategy for regulatory documents- Plan, write, edit, coordinate, review, and complete regulatory documents supporting clinical development and product registration- Coordinate document initiation meetings to reach authoring team alignment- Schedule the performance of document quality reviews for accuracy- Resolve reviewer\'s comments and adjust document content based on internal/external feedback. Project and Stakeholder management- Lead the writing process and apply project management skills to ensure timely completion of high-quality regulatory documents- Construct or negotiate project timelines with stakeholders and authoring team- Anticipate and mitigate risks to delivery, escalate issues as appropriate, to ensure document completion. Knowledge and Skills Development- Enhance therapeutic area knowledge including disease state or compound(s) for assigned project(s)- Maintain knowledge of regulatory guidelines- Exhibit flexibility in moving across document types, therapeutic areas, and molecules- Maintain science communication skills to align with changes with the audience, technology, and platforms. Knowledge Sharing - Coach colleagues by sharing technical information, giving guidance, and answering questions- Recognized for technical expertise in specific document development- Network with colleagues in other functions and regions to identify and share best practices.

Munster Technological University

Bachelor of Science - BSc (Hons), Pharmaceutical Biotechnology

Munster Technological University

Doctor of Philosophy - PhD