Advisor/Sr Advisor – Drug Delivery and Digital Health Regulatory in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Advisor/Sr Advisor – Drug Delivery and Digital Health Regulatory in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Advisor/Sr Advisor – Drug Delivery and Digital Health Regulatory

Location : Indianapolis, Indiana

Job id: R-32928

 

Job Details

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.Organization Overview: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. Responsibilities:Regulatory and Scientific Expertise  Technical knowledge of drug delivery and/or medical device, including software, systems development science(s).Recognized within GRA-NA for broad knowledge of labeling, global delivery system and/or medical device regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations.Manage the development of regulatory strategy and update strategy based upon regulatory changes. Provide high quality, timely and decisive regulatory advice to allow product teams to make well-informed decisions on development or product lifecycle planning, including labeling and US advertising and promotion review. Evaluates regulatory impact on proposed delivery systems and/or medical device development plans. Anticipates and resolves key technical or operational issues that can impact the function or product team Participates in regulatory risk analysis, internal and external audits for regulatory compliance. Demonstrates strong skills in technical and concise writing of Regulatory documents resulting in effective communication and maximizing feedback from regulators.    Lead Device Labelling Development  Lead preparation, review and finalization of core medical device, connected drug delivery and new drug delivery platform labeling documents and deliverables for US and Canada submissions, responses to agency questions and lifecycle management for assigned projects. Evaluate impact of global labelling changes for supported devices, exceptions to core device labeling, and the impact of anticipated labelling on proposed device development plans. Provide oversight to vendors creating labeling deliverables for supported devices. Participate in software device User Interface content reviews. Initiate and lead product/platform claims mapping with Global and/or US marketing and cross functional team.  Review Medical and Combination Device US Promotional Materials Demonstrate regulatory leadership and influence to advise US Commercial business on executing compliant advertising and promotional materials for medical devices, including software products and/or mobile medical applications. 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, provider and payer).   Influence Networks throughout Global Regulatory Affairs, as appropriate, building awareness and alignment on Regulatory Delivery Systems and/or medical device strategies.  Provides regulatory guidance to product teams and implements regulatory strategies that result in successful product registrations.Exhibits strong leadership behaviors. Incorporates new regulations, guidance and company positions into GRA-Device processes/guidelines, tools and/or training materials. Supports internal policy development and provides internal input on emerging regulations worldwide for device issues. Participates in industry organizations to increase Lilly’s visibility and influence of evolving regulatory positions.  Lead/Partner Leads preparation, review and finalization of device documents for global clinical trial authorizations (CTA) and registration submissions and response to questions. Takes a proactive support role in the critical review of device specific development strategies and submission content. Supports strategies impacting product submissions across geographies and networks for alignment with Team members.Proactively identifies and resolves global device regulatory issues, leveraging internal experts and/or management to develop complex regulatory strategies. Develop relationships with personnel in other Lilly functional areas (i.e. DDCS, Digital Health (DH), Product Research and Development (PRD), Global Patient Safety (GPS), manufacturing, quality, medical, US marketing etc.) that promote open discussion of issues. Demonstrated ability to influence drug and/or device development strategies.   Communicates effectively verbally and in 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. Basic Requirements:Bachelor’s Degree in a scientific or engineering discipline (e.g. chemistry, biology, biochemistry, pharmacy, engineering or related scientific discipline)  7+ years of Medical Device or Pharmaceutical industry experience in technical drug and/or device development3+ years of prior regulatory experience or equivalent combination of technical and regulatory guidance knowledge Additional Preferences:Advanced DegreePrior experience authoring submission content Prior experience developing device Instructions for Use and U.S. medical device advertising and promotion regulatory review.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  Eli 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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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 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).

 

 

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