Lilly Regulatory Advertising Medical Device Reviewer in Indianapolis, Indiana
Type of Employment:
Full-Time Employment - FTE
The Drug Delivery and Digital Health (DDDH) US Regulatory Advertising and Promotion medical device and combination drug/device reviewer is responsible for demonstrating regulatory leadership and influence to advise the US Commercial business on executing compliant advertising and promotional materials for medical devices, including software product and/or mobile medical applications. In this role you will 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). You may support DDDH medical device and connected combination product labeling responsibilities including leading or providing oversight in the development of high quality global (core) and US and Canada medical device labeling.
Provide effective leadership and regulatory expertise to Lilly partners (80%)
Accomplished by working with applicable US Marketing Teams and Business Communications to ensure
Compliance with all applicable regulations, internal policies and quality systems
High quality, timely and decisive regulatory advice to allow business partners to make well informed decisions
Development of communications that educate customers about Lilly medical devices including software product and/or mobile medical applications by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policies
Support implementation of the promotional material quality system, including setting appropriate direction with US Marketing Team for development, review and approval of product communications within the established processes
Provide timely completion of impact assessments for deviation management and input into change controls related to promotional material
Attend US Marketing Team meetings regularly and participate actively in making recommendations regarding proposed promotional activity plans
Develop relationships with personnel in other Lilly functional areas (i.e., marketing, device development, medical, health outcomes, legal, labeling, compliance, quality etc.) to effectively influence the implementation of appropriate promotional messages
Constructively challenge teams to reach the best solutions to issues. Demonstrate strong problem-solving skills and ability to address and effectively communicate complex regulatory issues
Provide input into risk mitigation strategies to inform and influence business leaders by monitoring and communicating factors and trends in the external environment related to advertising and promotion topics from FDA and FTC actions and Company learning through interactions with FDA
Advise business partners on impact of new FDA and FTC Guidance and FDA social scientist research publications to promotional activities and practices
Provide Regulatory guidance for promotional press materials and scientific disclosures to media customers
Serve as key subject matter expert with Regulatory peers and business partners on topic(s) relevant to external medical device and mobile medical application communications.
Actively monitoring external environment for updates on topic(s)
Periodically share updates by presentation or summary reports
Provide ad hoc consultation
Engage in external forums, including conferences
Exercise accountability for knowledge transfer across GRA
Partnering with Device Regulatory Director and Device Regulatory Scientists from Global Regulatory Affairs (GRA) to consider FDA perspectives on device development requirements and relevance to advertising decisions and claims
Developing an understanding regarding the background of regulatory and marketing history of applicable products
Regularly communicating with other components in the GRA organization (i.e., d e v i c e , labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support product teams
Being recognized as a technical expert in a specific area, product or a functional area
Attending internal and external training programs and educational forums, such as staff meetings, town halls, DIA, FDLI, AdvaMed and RAPS meetings.
Sharing lessons learned in forums such as GRA staff meetings
Contributing to the development of others by serving as a mentor for GRA personnel
Modeling the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
Lead Device Labeling Development
Support the regulatory scientist in developing and refining the device labelling strategy, including use of expertise to confirm/challenge/influence strategies based on industry precedent and new developments.
Engage in risk-benefit analysis/AFMEA preparation, device and/or system labeling requirements, Human Factors testing, packaging and convenience kit development in the U.S. and major markets.
Provide oversight to vendors creating labeling deliverables for medical devices.
Lead preparation, review, and finalization of device labelling documents for submissions and responses to agency questions for assigned projects.
Develop global device/combination product labelling strategies in collaboration with other regulatory, development and project personnel and network for alignment across product team to enable timely completion of product registration milestones (submission, approval and launch).
Evaluate impact of global labelling changes for medical devices, exceptions to core device labeling, and the impact of anticipated labelling on proposed device development plans.
Bachelor's Degree in a scientific discipline.
Minimum of 3 years of US regulatory advertising and promotion experience for medical devices, including software product and/or mobile medical applications
Significant industry-related experience in drug development and/or commercialization
Comprehensive knowledge of FTC rules and decisions and FDA procedures and practices (CFR guidelines,
Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)
Knowledge of regulatory/business strategies and plans.
Demonstrated ability to influence without authority
Demonstrated ability to deliver complex projects against a timeline
Strong communication skills (active listening, verbal, and written)
Demonstrated ability to apply systematic thinking/mindset to business problems and opportunities
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
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.
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 39,000 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. #WeAreLilly
Region: North America
Req Id: 54544BR