Associate/Sr. Associate Technical Writer
9 hours ago
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.
Job Description
At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. Our 41,000 employees 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.
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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Purpose:
The Technical Writer is responsible for supporting the 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:
1. Ensure timely delivery of error-free, high-quality documents that meet international standards of written English.
2. 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.
3. Verify quality system architecture accuracy and consistency of content within and between related documents.
4. Coordinate with MQO Quality Systems on editing, quality checks and data integrity reviews.
5. Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
6. Facilitate the review/approval process required for all documents. Reconcile reviewer feedback and address all issues.
7. Exhibit flexibility in moving across development and preparation of multiple document types.
8. Participate on project teams as applicable. Manage key quality processes through QMS lifecycle management to ensure SEQS documents in assigned area reflect the current business processes and quality parameters.
Document Control:
1. Launch templates and manage document metadata.
2. Ensure the accuracy and completeness of document control records, including document revision histories, revisions, approvals, and related metadata.
3. Track status, milestones & associated documentation throughout the workflow.
4. Influence or negotiate change of timelines and content with other team members.
Knowledge and Skill Development:
1. Maintain and enhance Safety and Efficacy system knowledge for assigned project(s).
2. Maintain proficiency in applicable software, tools, processes, and workflows.
3. Provide coaching to others by sharing technical information, giving guidance, answering questions.
4. Exhibit flexibility in moving across document types, functional areas, depending on project assignment.
5. Maintain and enhance knowledge of Lilly procedures, and compliance/business requirements.
Qualification Requirements:
1. Bachelor’s degree (or equivalent work experience) in a scientific, health, communications, technology health related field.
2. Minimum 3 years experience in technical/medical writing.
3. Experience using Veeva QualityDocs or other electronic document management systems (EDMS).
Other Information/Additional Preferences:
1. Experience in a regulated environment.
2. Specialized knowledge of editing & proofreading techniques.
3. Excellent attention to detail and organizational skills.
4. Strong communication and interpersonal skills.
5. Ability to manage multiple projects and priorities simultaneously.
6. Demonstrated project management and time management skills.
7. Ability to work well independently and as part of a team, within and across culturally and geographically diverse environments.
8. 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.
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.
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