Expert Specialist - Global Scientific Communications - Regulatory

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ 

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. 

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to 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.

The purpose of the Specialist, GSC Regulatory role is to support the delivery of GSC regulatory documents with all aspects of regulatory document planning, tracking, and compliance.  The Regulatory Specialist is responsible for assisting the team, in managing and maintaining the regulatory document planning and tracking tools.  They are also responsible for generating status, productivity, and other metrics reports for the regulatory document team.  Conducting quality reviews required for regulatory documents prior to finalization is also part of the responsibilities.  The Specialist supports the team by ensuring that regulatory documents are compliant with guidelines, Lilly policies, and any external requirements.

The Specialist will independently interact with teams in other functional areas and with external vendors as needed.

This role is a 12 month fixed term position

Primary Responsibilities:  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.

Regulatory Document Delivery Process Expert

• Serve as a regulatory document delivery process expert; understand required workflow, tools, and processes.
• Maintain proficiency in applicable software and current tools.
• Keep regulatory document tools updated in a timely fashion, consistently and accurately, which involves creating new records, tracking projects as they progress through the systems, closing projects, and remediating records as needed. 
• Execute metrics reports using data extracted from software tools to drill down into operational aspects of a project.
• Audit regulatory workflow tools for consistency and optimal use.
• Use creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to global workflow.
• Serve as a resource for others associated with document process/products and be an expert on specifications, timelines, and process. Help develop training materials and related change man