Lilly Associate Director - Regulatory Affairs - Advertising and Promotion 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. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Within Regulatory Affairs, the US Advertising and Promotion Team provides leadership to deliver accurate, balanced and substantiated product/disease communication for assigned assets. We are seeking a Regulatory Lead to partner with a multitude of teams including regulatory science, cross-functional partners, and the FDA Office of Prescription Drug Promotion (OPDP). This collaboration of teams will guide the regulatory requirements and expectations for compliant communications.
Within the role, the Regulatory Lead will have the opportunity to express their regulatory experience through many channels. These areas of opportunity include:
Review of Promotional Tactics and Communication
Serve as Regulatory representative for US brand teams, US Medical Affairs, and Corporate Business Communications for promotional tactics, internal field-based communications, medical affair communications, and campaign tactics for media events
Provide high quality, prompt and conclusive regulatory advice that enables business partners to make well-informed decisions
Communicate regulator expectations by utilizing OPDP feedback received by Lilly, interpretation of applicable laws, regulations and guidances, and knowledge of FDA enforcement actions.
Contribute to business risk mitigation strategies by following trends in external environment related to advertising, promotion and medical communication topics
Build, maintain, and utilize relationships with Lilly team members and partner companies, as appropriate, to effectively influence the implementation of appropriate communications.
Initiate promotional tactic discontinuation plans for Regulatory-initiated events
Facilitate Interaction with FDA OPDP
Counsel internal partners on OPDP advisory strategy; collaborate with marketing and advertising agency in development of promotional proposals, and provide quality review of submission documents
Partner with US brand team to interpret OPDP advice and support any interactions with OPDP
Provide a well-timed and quality review of 2253 promotional material submissions to FDA
Collaborate with Other Regulatory colleagues
Engage US Regulatory Scientist in 1) development and analysis of promotional claims and suggest marketing on promotional strategy and 2) review of press materials and IR communications.
Work closely with US Regulatory Scientist and Labeling Operations to lead labeling revisions to balance consideration of business implication and regulatory compliance
Communicate and share key information to enable seamless execution of US regulatory strategy and promotional activity
Engage in forums that share regulatory information across the organization, other Lilly teams, and business partners
Constructively challenge teams to reach the best solutions to issues
Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions
- Bachelor's Degree
Experience in regulatory advertising and promotion preferred
Knowledge of FDA procedures and practices (CFR guidelines, Guidances, etc.)
Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)
Knowledge of drug development process, regulatory/business strategies and plans
Strong ability to influence without authority and ability to deliver sophisticated projects against a timeline.
Strong communication skills (active listening, verbal, and written)
Proven track record of applying systematic thinking/mentality to business problems and opportunities
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Primary location: Indianapolis, IN Secondary Location: Remote
Lilly currently anticipates that the base salary for this position could range from between $103,500 to $152,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will 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 company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.
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 ( LillyRecruitingCompliance@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.
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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).