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.

Overview

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

The purpose of the Clinical Trial Registry and Transparency Associate is to lead development and preparation of documents for public disclosures according to Lilly systems and processes, ensuring Global transparency regulations and requirements are followed. The Clinical Trial Registry and Transparency Associate will collaborate with cross-functional, multidisciplinary teams across multiple geographies and phases of drug development to ensure/coordinate the accurate and timely disclosure of clinical trial information.

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.

1.Content Strategy and Execution:  Document Preparation, Development and Finalization/Document ManagementDemonstrates expertise in the clinical transparency and disclosure environment, with a specific focus in one or more of the following areas: clinical trial registration on clinicaltrials.gov; trial results posting on CT.gov, EUDRA.CT/EU CTIS; plain language summaries of study results; document redaction, including Health Canada and EMA Policy 70 transparency submissions.Effectively identify, collect and evaluate documents, data, and input from multiple sources, functions, and regions to plan and prepare transparency deliverables.Conduct effective project initiation/kickoff meeting to ensure product/study team alignment and understanding.Ensure information is presented in a clear, complete, accurate, and concise manner.Ensure that key data/information/redactions are consistent across related deliverables.Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of deliverable as required based on internal/external input, and prepare final version.Ensure and coordinate quality checks for accuracy.Influence or negotiate change of timelines and content with team members.As needed, may build and manage relationships with vendors/alliance partners.2.Project and Stakeholder managementLead the content creation and/or redaction process and apply effective project management skills to ensure timely completion of high-quality transparency deliverables.Build/communicate credible project timelines.Anticipate and mitigate risks to delivery.Work with teams and stakeholders to ensure smooth and timely work delivery and escalate issues, as appropriate, to ensure project completion.Effectively communicate project status to stakeholders.3.Knowledge and Skills DevelopmentMaintain and enhance knowledge of transparency regulations and guidelines.Maintain expertise in personal information and company confidential information identification.Maintain knowledge/expertise in plain language/health literacy concepts, and creating content for a lay audience.

Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).Exhibit flexibility in moving across therapeutic areas, phase of development and deliverable types as needed.Maintain and enhance transparency skills and changes in technology and platforms.4.Knowledge SharingProvide coaching to others by sharing technical information, giving guidance, answering questions.Recognized for technical expertise in specific area of focus (trial registration, trial results, PLS, redaction).Network with others (including other functions and regions) to identify and share best practices.Contribute to process improvements, suggesting opportunities where appropriate.Provide database and tool/technology expertise.

Minimum Qualification Requirements:

Bachelor’s degree in a scientific, health, or communications related field or, bachelor’s degree in any field with at least two years of transparency.High-level end-user computer skills (Adobe, MS Office applications, Word, Excel, PowerPoint).Mastery of English language skills, written and spoken.

Other Information/Additional Preferences:

Experience with transparency processes (CT Registry, Redaction, Plain Language Summary), including knowledge of regulations, guidelines and standardsUnderstanding of biostatistics and clinical study designs.Verbal reasoning, attention to detail, critical thinking, and analytical ability.Demonstrated project management and time management skills. Ability to deal with ambiguity and to plan, prioritize, and manage conflicting priorities.Experience working with multiple functional areas across medical, regulatory, and legal and multiple time zones

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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