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.
Purpose: The purpose of the Scientist/Sr. Scientist/Principal Scientist (R1-3) role is to provide tactical, and operational direction and support to expedite device related (drug-device delivery systems, medical devices (firmware, hardware, stand alone and embedded software) or diagnostic) 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; Drug Delivery, Digital Health and Diagnostic department operations.
The Scientist utilizes device technical knowledge, regulatory and device expertise to drive internal consistency and influence effective change management.
Primary Responsibilities: Regulatory and Scientific ExpertiseTechnical 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.InfluenceProvide 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 Health Authorities as required, including key ISO and notified body personnel.Lead/Support/PartnerSupport 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 MakingProactively identifies 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)Medical Device or Pharmaceutical industry experience in technical drug and/or device development (3-4 years)Prior experience authoring device submission contentPrior regulatory experience (2-3 years) or equivalent combination of technical and regulatory guidance knowledgeDemonstrated negotiation and influence skills.Demonstrated strong written, spoken and presentation communication skillsDemonstrated attention to detailDemonstrated effective teamwork skills; able to adapt to diverse interpersonal stylesOther Information/Additional Preferences: English FluencyEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources for further assistance. Please note this email address is intended for use only to request an accommodation as part of the application process. 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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