Lilly Advisor-Regulatory in Indianapolis, Indiana

42455BR

Responsibilities:

Purpose:

The Advisor, Global Regulatory Affairs - US Regulatory Advertising and Promotion Reviewer, is responsible for demonstrating regulatory leadership and influence in facilitating effective partnerships with US Brand Teams, Global Marketing, Global Business Communications, and Global Medical Affairs working along with other cross-functional partners to consistently and efficiently develop and deliver accurate, balanced, substantiated product and disease information which enables informed decision making by our customers (patient, provider and payer). The Advisor utilizes therapeutic area regulatory expertise and lessons learned across a therapeutic area to drive internal consistency and influence effective change management with US Brand Team and other leadership. Additionally, the Advisor acts as chief spokesperson and lead negotiator during the internal strategy discussions, preparation and implementation of interactions with the FDA Office of Prescription Drug Promotion (OPDP). The Advisor will also provide regulatory guidance during assessments of the clinical and commercialization plans for further development of assigned marketed product.

Responsibilities:

  1. Provide effective leadership and regulatory expertise to Lilly partners (80% of time)

  2. Accomplished by working with applicable US Brand Teams, Global Marketing, Global Business Communications, and Global Medical Affairs to ensure

  3. Compliance with all applicable regulations, internal policies and quality systems

  4. High quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions

  5. Development of communications that educate customers about the benefits and risks of Lilly products by introducing multiple alternative approaches that may meet the business objectives while maintaining compliance with applicable regulations and internal policies

  6. Support implementation of the Customer Information Quality (CIQ) system, including setting appropriate direction with Brand Team for development, review and approval of claims and product communications within the CIQ processes

  7. Provide timely completion of impact assesments for deviation management, input into change controls, and quality review of promotional material submissions to FDA for assigned marketed product

  8. Attend US Brand Team meetings regularly and participate actively in making recommendations regarding proposed promotional activity plans

  9. Develop relationships with personnel in other Lilly functional areas (i.e., marketing, medical, legal, labeling, compliance, quality etc.) to effectively influence the implementation of appropriate promotional messages

  10. 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

  11. Provide oversight of interactions with OPDP including:

  12. Developing collegial, mutually productive relationships with the OPDP to enable Lilly to negotiate mutually beneficial solutions to identified issues

  13. Proactively preparing team members and leading OPDP discussions in order to promote effective written and verbal communications with FDA

  14. 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 therapeutic area regulatory expertise and advertising and promotion topics from OPDP enforcement actions and Company learning across Business Units through interactions with FDA

  15. Advise business partners on impact of new OPDP Guidances and OPDP social scientist research publications to promotional activities and practices

  16. Provide regulatory guidance during assessments of the clinical and commercialization plans for further development of assigned marketed product

  17. Provide Regulatory guidance for market research and global launch campaign development

  18. Provide Regulatory guidance for promotional press materials and scientific disclosures to media customers

  19. Provide Regulatory guidance for digital Lilly medical communications, presentations by medical affairs, and exhibit booth for scientific Congresses

  20. Serve as key subject matter expert with Regulatory peers and business partners on topic(s) relevant to external medical product 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

  1. Exercise accountability for knowledge transfer across GRA (10% of time)

This is accomplished by:

  • Partnering with Therapeutic Directors and Regulatory Research Scientist from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions

  • Engaging with GRA labeling experts to develop strategy on product labeling components that appropriately balances consideration of business implication and regulatory compliance

  • 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., labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support pre- and post-approval teams

  • Being recognized as a technical expert in a specific area, product/class or a functional area

  • Attending internal and external training programs, such as staff meetings, town halls, DIA, FDLI and RAPS meetings.

  • Sharing lessons learned in forums such as GRA staff meetings

  • Contributes to the development of others by serving as a mentor for GRA personnel

  • Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.

Req ID:

42455BR

Additional Skills/Preferences:

  • Significant industry-related experience in drug development and/or commercialization

  • Comprehensive knowledge of FDA procedures and practices across Review Divisions and OPDP (CFR guidelines, Guidances, etc.)

  • Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.)

  • Knowledge of dregulatory/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:

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.

Title:

US Regulatory Advertising and Promotion Reviewer

Job Category:

Regulatory Affairs

Basic Qualifications:

  • Bachelor's Degree

  • A minimum of 3 years of experience in Regulatory Advertising and Promotion

  • 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

Company Overview:

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.

City:

Indianapolis

Country:

USA

State / Province:

Indiana

Region:

North America