Intern - EMEA CT Submission Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters.

Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Positions: 1 Start date: June 2027 Duration: 12 weeks Salary: €30,500 pro rata Location: Lilly GBS, Little Island Cork Type: Hybrid role requiring the successful candidate to be on site 50% of the month in Little Island, Cork and 50% working remotely.

Course Eligibility: UCC Students from a Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, Pharmaceutical Regulatory Science, Biomedical or Biopharmaceutical Sciences, Biochemistry, Pharmacology, Biotechnology, Life Sciences, Clinical Research, Health Sciences or a similar related field.

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!

Purpose: The GRA-EMEA Clinical Trial Submissions Intern joins the team on a supported learning placement, gaining hands-on experience of how clinical trials are approved and maintained across the European Union.

Working alongside experienced colleagues who provide training and mentoring, the intern supports the delivery of high quality, efficient regulatory clinical trial submissions in compliance with local regulations.

Responsibilities will be tailored to the intern's skills, interests and capabilities. 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. Clinical Trial Applications (supporting role) • Help prepare and organise documents for Clinical Trial Applications (CTAs), following guidance from colleagues.

• Observe CTA kick-off meetings and help with meeting preparation and notes. • Help check submission documents for accuracy and completeness before submission.

• Learn how questions from regulatory agencies are handled and answered. • Update trackers and internal systems with key milestones. • Learn how the team works with Third Party Operations.

• undefined Modifications/ Trial Maintenance (supporting role) • • Help organise and prepare documents for trial modifications. • Help check documents for accuracy before submission.

• Keep trackers and systems up to date as modifications progress. Learning and Team Support • Learn about EU clinical trial regulations and guidelines through training and shadowing.

• Learn about compliance, quality systems and good documentation practices. • Help with team administration such as filing and meeting preparation. • Explore how AI tools can make routine tasks faster, such as templates and stakeholder update emails.

Team Contribution • Take part in team meetings and learning sessions. • Ask questions and share ideas for making routine tasks simpler. • Support colleagues with ad hoc tasks as needed.

• Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver. • Contribute to an inclusive team environment where open discussion is encouraged.

Minimum Qualification Requirements: • Currently studying or recently completed a third-level course (science, health, business or related fields preferred; all disciplines welcome) • Good English, written and spoken • Willingness to learn and to work as part of a team • Clear written and verbal communication skills • Attention to detail • Good organisational skills and proactivity • Ability to work independently with support, and in a team • No prior industry or regulatory experience 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is € - € Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.

g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.