Lilly Advisor/Sr Advisor – Drug Delivery and Digital Health Regulatory in Indianapolis, Indiana
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 35,000 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.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
The purpose of this role is to provide strategic, tactical and operational direction and support to expediate device (delivery system, medical devices (firmware, hardware, stand alone and embedded software)) development of Lilly’s portfolio by interacting with teams and regulators to support development of regulatory strategies and US/Canada submissions in support of clinical trials, market clearance, approvals, global registrations support and product maintenance. The Advisor/Sr Advisor utilizes device technical knowledge and regulatory, device, and labeling (US, Canada and Core) expertise to drive internal consistency and influence effective change management. The Advisor/Sr Advisor supports US Regulatory Advertising and Promotion medical device and combination drug/device reviewer responsibilities, including demonstrating regulatory leadership and influence to advise the US Commercial business on executing compliant advertising and promotional materials for medical devices.
Regulatory and Scientific Expertise
Technical knowledge of drug delivery and/ormedicaldevice, including software,systems development science(s).
Recognized within GRA-NA for broad knowledge oflabeling,global delivery system and/ormedical deviceregulatory requirementsand guidelines for conducting clinical trials and obtaining global product registrations.
Managethe development of regulatory strategy and update strategy basedupon regulatory changes.
Provide high quality, timely and decisive regulatory advice to allow product teams to make well-informed decisions on developmentorproduct lifecycle planning,includinglabeling and US advertising and promotionreview.
Evaluatesregulatoryimpact on proposed delivery systems and/ormedicaldevicedevelopment plans.
Anticipates and resolves key technical or operational issues thatcanimpact the function or product team
Participates inregulatory riskanalysis,internal and external auditsfor regulatory compliance.
Demonstrates strong skillsintechnical andconcise writingof Regulatory documentsresulting in effective communicationand maximizing feedback from regulators.
Lead Device Labelling Development
Lead preparation, review and finalization ofcoremedicaldevice, connected drug delivery and new drug delivery platformlabeling documentsand deliverablesforUS and Canadasubmissions,responsesto agency questionsand lifecycle managementfor assignedprojects.
Evaluate impact of global labelling changes forsupporteddevices, exceptions to core device labeling,and the impact of anticipated labellingon proposed device developmentplans.
Provide oversight to vendors creating labeling deliverables forsupporteddevices.
Participate insoftwaredeviceUser Interface content reviews.
Initiate and leadproduct/platform claims mapping with Global and/or US marketingandcross functional team.
Review Medical and Combination Device US Promotional Materials
Demonstrateregulatory leadership and influence to adviseUSCommercial business on executing compliant advertising and promotional materials for medical devices, including softwareproductsand/or mobile medicalapplications.
Develop effective partnerships with Marketing and Business Communications working along with other cross-functional partners to consistently and efficiently develop and deliver accurate, balanced, and substantiated information about medical devices, including software product and/or mobile medical applications, and combination drug/device products,to enable informed decision making by our US customers (patient,providerand payer).
Networks throughout Global Regulatory Affairs, asappropriate, building awareness and alignment on RegulatoryDelivery Systems and/or medical devicestrategies.
Providesregulatory guidance to product teams and implements regulatorystrategies that result in successful product registrations.
Exhibits strong leadership behaviors.
Incorporates new regulations, guidance and company positions into GRA-Deviceprocesses/guidelines, tools and/or training materials.
Supportsinternal policy development andprovidesinternal input on emerging regulations worldwide for device issues.
Participates in industry organizations to increase Lilly’s visibility and influence of evolving regulatory positions.
Leads preparation,reviewand finalization ofdevice documents for globalclinical trialauthorizations(CTA)and registration submissions and response to questions.
Takesa proactivesupportrole in the critical reviewof device specific development strategies and submission content.
Supportsstrategies impacting product submissions across geographies and networks for alignment with Team members.
Proactivelyidentifies andresolves global device regulatory issues, leveraging internal experts and/or management todevelopcomplex regulatory strategies.
Develop relationships withpersonnel in other Lilly functional areas (i.e.DDCS,Digital Health (DH),Product Research and Development (PRD),Global Patient Safety (GPS),manufacturing, quality, medical, USmarketing etc.) that promote open discussion of issues.
Demonstrated ability to influence drug and/or device development strategies.
Communicates effectively verbally andin writing to influence within work group/function and with development team.
Participate in forums that share regulatory information across GRA.
Participates in the development of corporate positions on, and responses to, proposed agency regulations and guidelines.
Bachelor’s Degree in a scientificor engineeringdiscipline (e.g.chemistry, biology, biochemistry, pharmacy,engineering or related scientific discipline)
7+ years of Medical Deviceor Pharmaceutical industryexperiencein technical drug and/ordevicedevelopment
3+ years of prior regulatory experience or equivalent combination of technical and regulatory guidance knowledge
Prior experience authoring submissioncontent
Prior experience developing device Instructions for Use and U.S. medical device advertising and promotion regulatory review.
Demonstratedstrong written, spoken and presentationcommunicationskills
Demonstrated attention to detail
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
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Lilly is an EEO/Affirmative Action Employer and 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).