Eli Lilly and Company

US Regulatory Advertising and Promotion Medical Device Reviewer

Location
Indianapolis, IN, United States
Posted
Dec 03, 2018
Ref
43625
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities
The 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).

Some of your responsibilities will include:
Provide effective leadership and regulatory expertise to Lilly partners (80% of time)
  • Accomplished by working with applicable US Marketing Teams and Business Communications to ensure
    1. Compliance with all applicable regulations, internal policies and quality systems
    2. High quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions
    3. Development of communications that educate customers about Lilly medical devices including software product and/or mobile medical applications by introducing multiplealternative 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 assesments 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 pl ans
  • Develop relationships with personnel in other Lilly functional areas (i.e., marketing, device development, medical, health outcomes, legal, labeling, c ompliance, 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 Guidances 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 (10% of time)

This is accomplished by:
  • 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 (10% of time)
This is accomplished by:
  • 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., device, 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.
43625BR

Basic Qualifications
  • Bachelor's Degree
  • Minimum of 3 years of US regulatory advertising and promotion experience for medical devices, including software product and/or mobile medical applications
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


Additional Skills/Preferences
  • Significant industry-related experience in drug development and/or commercialization
  • Comprehensive knowledge of FTC rules and decisions and FDA procedures and practices (CFR guidelines, Guidances, etc.)
  • 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


Additional Information
  • Minimum travel expected (<25%)
  • 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