Sr. Scientist/Principal Scientist

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.

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 purpose of the Sr. Scientist/Principal Scientist role is to provide tactical, and operational direction and support to expediate device related (drug-device delivery systems, medical devices (firmware, hardware, stand alone and embedded software) registrations, right to operate and maintenance of Lilly’s portfolio by interacting with teams, affiliates, and regulators. This role will support global registrations, product maintenance, and GRA-Devices: GRA-CMCD Drug Delivery Device department operations. The Scientist utilizes device technical knowledge, regulatory and device expertise to drive internal consistency and influence effective change management.

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. Regulatory and Scientific Expertise Technical knowledge of drug delivery and/or medical device, including software, systems development science(s) development and lifecycle management. Support evaluation of regulatory impact on proposed delivery systems and/or medical device change management plans. Anticipate and resolve key technical or operational issues that can impact the function or product team. Support regulatory risk – benefit analysis, internal and external audits for regulatory compliance. Demonstrate strong skills in technical and concise writing of Regulatory documents resulting in effective communication and maximizing feedback from regulators. Influence Provide regulatory guidance to product teams and/or affiliates while implementing regulatory strategies that result in successful global product registrations and device maintenance. Exhibit leadership behaviors. Incorporate new regulations, guidance and company positions into GRA-Device processes/guidelines, tools and/or training materials. Support internal policy development and provide internal input on emerging regulations worldwide for device issues. Monitor global regulatory news and provide interpretation and internal communication as appropriate. Support interactions with global Heath Authorities as required, including key ISO and notified body personnel. Lead/Support/Partner Support preparation, review, and finalization of device documents for global clinical trial authorizations (CTA), registration submissions, response to questions and change control activities. Support strategies impacting product submissions across geographies. Proactively identify and resolve device regulatory issues, leveraging internal experts and/or GRA-Devices s