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.

Purpose: 

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, transparent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.  

The Clinical Trial Registry and Transparency (CTRT) Specialist is responsible for collecting and preparing redacted documents/packages required to be submitted to EU Clinical Trial Regulation (EU CTR), EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), National Institute of Health (NIH), and other global disclosure and transparency regulations.  

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. 

Transparency Technical and Administrative support 

Develop knowledge and understanding of the redaction process. 

Collaborate cross functionally with applicable team members and departments (e.g., Statistics, medical, clinical trial management, Manufacturing CT Material Supply), to obtain and review documents needed for submission. 

Collect documents that will be submitted to EU Clinical Trial Regulation (EU CTR), EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), National Institute of Health (NIH), and other global regulations by searching Veeva Vault and other document repositories.  

Upload documents in Veeva Vault in preparation for CCI and PI review and assign tasks. 

Based on inputs, redact documents for personal information and company confidential information 

Manage EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI) and EU Clinical Trial Regulation (EU CTR) workflows in Veeva Vault. 

Manage redaction trackers and partner with Trial Capabilities, Design Hub to get most up-to-date information on studies to be submitted to EU CTIS. 

Identify opportunities for redaction process improvement. 

Other transparency requirements as needed: 

Identify, track and report on clinical trials required for disclosure. 

Quality check redaction work of other CTRT or vendor staff 

Manage access rights to applicable systems as needed. 

Create, maintain, and utilize technology effectively to manage CTRT tracking and reporting processes. 

Support CTRT systems, processes, and workflows. 

Communicate to responsible functions the deliverable needs, timelines, and deadlines for CTRT requirements. 

Escalates issues in a timely and appropriate manner. 

Shares key learning. 

Identify opportunities for redaction process improvement Minimum Qualification Requirements: 

Minimum Required Qualifications: 

Certificate/ Diploma equivalent required. 

Strong Interpersonal skills and the ability to be flexible in varying environments including working across time zones. 

Demonstrated high-level end-user computer skills (MS office applications: Word, Excel, PowerPoint, etc.). 

Strong written and oral communication skills, with demonstrated mastery of English language skills written and spoken. 

Information/Additional Preferences: 

Bachelor’s degree preferred. 

Background in clinical Data Disclosure & Transparency and Redaction 

Ability to be flexible in varying environments and with multiple customer groups. 

Ability to work well across cultures and time zones. 

Highly organized and able to manage multiple projects at any given time, with ability to work on concurrent projects in a timely manner and with high quality. 

Attention to detail and dedicated to excellence in all aspects of their work. 

Ability to work under pressure, while maintaining a positive attitude 

Able to work independently and collaboratively in a team environment. 

Project management experience. 

Willingness to travel as required. 

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.

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