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.

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 41,000 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.

Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 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, Age & Culture, LGBTQ+ 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!

Purpose:

The purpose of the Technical Writer is responsible for supporting Medicines Quality Organization (MQO) Quality Systems team to deliver high quality documents in the Safety and Efficacy Quality System (SEQS). The Technical Writer collaborates with the business on quality system document changes within the Safety and Efficacy Quality System. This role works closely with colleagues in Quality Systems, Global Regulatory Affairs (GRA), Global Patient Safety (GPS), Clinical Design, Delivery & Analytics (CDDA) and other components of the R&D organization. The Technical Writer is responsible for developing and maintaining accurate, clear, and concise procedures, required tools, and resource documents. The role is also responsible for quality checks of the quality system documents to ensure compliance with Lilly standards and procedures. This role manages workflows and metadata in the document control system using Veeva QualityDocs.

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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Quality Systems Document Management

▪ Ensure timely delivery of error-free, high-quality documents that meet international standards of written English

▪ Develop and maintain accurate, clear, and concise procedures, required tools, and resource documents using appropriate technical writing standards, templates, and style guides. Correct errors in grammar, style, formatting, and syntax.

▪ Verify quality system architecture accuracy and consistency of content within and between related documents.

▪ Coordinate with MQO Quality Systems on editing, quality checks and data integrity reviews.

▪ Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.

▪ Facilitate the review /approval process required for all documents. Reconciles reviewer feedback and address all issues.

▪ Exhibit flexibility in moving across development and preparation of multiple document types.

▪ Participates on project teams as applicable. ▪ Manages key quality processes through QMS lifecycle management (for example, periodic reviews) to ensure SEQS documents in assigned area reflect the current business processes and quality parameters.

▪ Document Control

▪ Launch templates and manage document metadata.

▪ Ensure the accuracy and completeness of document control records, including document revision histories, revisions, approvals, and related metadata.

▪ Track status, milestones & associated documentation throughout the workflow.

▪ Influence or negotiate change of timelines and content with other team members.

▪ Knowledge and Skill Development

▪ Maintains and enhances Safety and Efficacy system knowledge for assigned project(s).

▪ Maintain proficiency in applicable software, tools, processes, and workflows.

▪ Provide coaching to others by sharing technical information, giving guidance, answering questions.

▪ Exhibits flexibility in moving across document types, functional areas, depending on project assignment.

▪ Maintains and enhance knowledge of Lilly procedures, and compliance/business requirements.

Qualification Requirements:

▪ Bachelor’s degree (or equivalent work experience) in a scientific, health, communications, technology health related field.

▪ Minimum 3 years experience in technical/medical writing

▪ Experience using Veeva QualityDocs or other electronic document management systems (EDMS)

Other Information/Additional Preferences:

▪ Experience in a regulated environment.

▪ Specialized knowledge of editing & proofreading techniques.

▪ Excellent attention to detail and organizational skills.

▪ Strong communication and interpersonal skills.

▪ Ability to manage multiple projects and priorities simultaneously.

▪ Demonstrated project management and time management skills.

▪ Ability to work well independently and as part of a team, within and across culturally and geographically diverse environments.

▪ Limited travel: 0-10%

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly