Sr. Scientist - Global Regulatory Affairs - Drug Delivery Device

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 60nationalities who deliver innovative solutions that add value across a variety of BusinessService functions including Finance, Information Technology, Medical, Clinical Trialsand more. Eli Lilly Cork offers a premium workspace across our campus in Little Island,complete with flexible hybrid working options, healthcare, pension and life assurancebenefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. InhousePeople Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the careerexperience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for alldimensions 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 pillarfor people with disabilities and those that care for them, partners with the Access Lillyinitiative to make our physical and digital environment accessible and inclusive for all.Together they are committed to promoting awareness to create a disability confidentculture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! This is a 12 month contract. 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. 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 subject matter expert (SME) and/or mentor. Communicate effectively verbally and in writing to influence within work group/function and with product team. Support the development of corporate positions on, and responses to, proposed agency regulations and guidelines. Participate in forums that share regulatory information across GRA components. Collect and collate GRA-Devices metrics. Support regulatory impact assessments. Serve as electronic data systems SME. Support regulatory intelligence activities. Identify and execute other operational responsibilities. Decision Making Proactively identify and resolves device regulatory issues. Minimum Qualification Requirements: Bachelor’s degree in a scientific or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline) Other Requirements: Medical Device or Pharmaceutical industry experience in technical drug and/or device development (3-4 years) Prior experience authoring device submission content Prior regulatory experience (2-3 years) or equivalent combination of technical and regulatory guidance knowledge Demonstrated negotiation and influence skills. Demonstrated strong written, spoken and presentation communication skills Demonstrated attention to detail Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles Other Information/Additional Preferences: English Fluency 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 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. Lillydoes 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 €38,850 - €93,500 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.

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