Eli Lilly and Company
Sr. Director - US Regulatory Advertising/Promotion Therapeutic Lead (Oncology)
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
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 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:
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
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 can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Purpose:
The Sr. Director, GRA-NA, US Advertising and Promotion, is responsible for demonstrating regulatory leadership and influence in facilitating effective partnerships with assigned US Business Unit working along with other cross-functional leaders and alliance 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). To effectively partner and support the needs of the US Business Unit, the Sr. Director will lead a team of regulatory personnel, providing administrative oversight and direct supervision. The Sr. Director must also develop mutually productive relationships with the FDA Office of Prescription Drug Promotion (OPDP), Lilly components and alliance partners in support of marketed product activities. Additionally, the Sr. Director leads regulatory personnel during the internal strategy discussions, preparation and implementation of interactions with OPDP.Primary Responsibilities:
Coaches staff to ensure compliance with all applicable regulations, internal policies and quality systems.Provides high quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions.Develops promotional materials 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.Supports implementation of the Customer Information Quality (CIQ) system, including setting appropriate direction to staff on navigating development and approval of promotional tactics with review of product and disease state communications within the CIQ processes.Participates in performance management process for reporting staff members, providing input into salary administration and promotion recommendations, talent assessment, and succession planning discussions.Provides frequent reinforcement, coaching or feedback to staff and actively supports staff to share any new learning.Contributes to the development of others by mentoring and supporting individual staff member's career development with actionable development plans.Proactively recruits talented staff.Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.Provides coaching and oversight for contracted regulatory personnel supporting therapeutic area.Provide effective leadership and regulatory expertise to US Business Unit:
Supports implementation of the Customer Information Quality (CIQ) system, including timely completion of impact assessments for deviation management, input into change controls, and quality review of promotional material submissions to FDA.Attends US Business Unit meetings and participates actively in making recommendations regarding proposed promotional activity plans.Develops 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.Establishes effective collaborative relationships with Regulatory leadership at alliance partner company(ies), as applicable.Constructively challenges teams to reach the best solutions to issues. Demonstrates strong problem-solving skills and ability to address and effectively communicate complex regulatory issues.Provides 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.Exercise accountability for knowledge transfer across GRA:
Partners with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions.Develops an understanding regarding the background of regulatory and marketing history of applicable products in all US Business Units.Attends internal and external training programs, such as staff meetings, town halls, DIA, FDLI and RAPS meetings.Encourages staff to share lessons learned in forums such as GRA staff meetings.Lead/Influence/Partner:
Exemplifies Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.Regularly communicates across GRA components (e.g., labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support development and commercial teams.Participates in forums that share regulatory information across GRA components and other Lilly teams and business partners.Constructively challenges teams to reach the best solutions to issues.Creates and leads in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions.Serves as a mentor for GRA-NA personnel and others in GRA.Minimum Qualification Requirements:
Bachelor's Degree.10 years experience in US Regulatory Advertising and Promotion or related area.Additional skills/Preferences:
Knowledge of drug development process, Lilly 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.Comprehensive knowledge of FDA procedures and practices across Review Divisions and OPDP (CFR guidelines, Guidance, etc.).Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.).
#J-18808-Ljbffr
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
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 can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Purpose:
The Sr. Director, GRA-NA, US Advertising and Promotion, is responsible for demonstrating regulatory leadership and influence in facilitating effective partnerships with assigned US Business Unit working along with other cross-functional leaders and alliance 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). To effectively partner and support the needs of the US Business Unit, the Sr. Director will lead a team of regulatory personnel, providing administrative oversight and direct supervision. The Sr. Director must also develop mutually productive relationships with the FDA Office of Prescription Drug Promotion (OPDP), Lilly components and alliance partners in support of marketed product activities. Additionally, the Sr. Director leads regulatory personnel during the internal strategy discussions, preparation and implementation of interactions with OPDP.Primary Responsibilities:
Coaches staff to ensure compliance with all applicable regulations, internal policies and quality systems.Provides high quality, timely and decisive regulatory advice to allow business partners to make well-informed decisions.Develops promotional materials 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.Supports implementation of the Customer Information Quality (CIQ) system, including setting appropriate direction to staff on navigating development and approval of promotional tactics with review of product and disease state communications within the CIQ processes.Participates in performance management process for reporting staff members, providing input into salary administration and promotion recommendations, talent assessment, and succession planning discussions.Provides frequent reinforcement, coaching or feedback to staff and actively supports staff to share any new learning.Contributes to the development of others by mentoring and supporting individual staff member's career development with actionable development plans.Proactively recruits talented staff.Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.Provides coaching and oversight for contracted regulatory personnel supporting therapeutic area.Provide effective leadership and regulatory expertise to US Business Unit:
Supports implementation of the Customer Information Quality (CIQ) system, including timely completion of impact assessments for deviation management, input into change controls, and quality review of promotional material submissions to FDA.Attends US Business Unit meetings and participates actively in making recommendations regarding proposed promotional activity plans.Develops 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.Establishes effective collaborative relationships with Regulatory leadership at alliance partner company(ies), as applicable.Constructively challenges teams to reach the best solutions to issues. Demonstrates strong problem-solving skills and ability to address and effectively communicate complex regulatory issues.Provides 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.Exercise accountability for knowledge transfer across GRA:
Partners with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions.Develops an understanding regarding the background of regulatory and marketing history of applicable products in all US Business Units.Attends internal and external training programs, such as staff meetings, town halls, DIA, FDLI and RAPS meetings.Encourages staff to share lessons learned in forums such as GRA staff meetings.Lead/Influence/Partner:
Exemplifies Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.Models the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.Regularly communicates across GRA components (e.g., labeling, central registration, regulatory intelligence) to facilitate sharing of information that allows the entire component to more effectively support development and commercial teams.Participates in forums that share regulatory information across GRA components and other Lilly teams and business partners.Constructively challenges teams to reach the best solutions to issues.Creates and leads in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions.Serves as a mentor for GRA-NA personnel and others in GRA.Minimum Qualification Requirements:
Bachelor's Degree.10 years experience in US Regulatory Advertising and Promotion or related area.Additional skills/Preferences:
Knowledge of drug development process, Lilly 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.Comprehensive knowledge of FDA procedures and practices across Review Divisions and OPDP (CFR guidelines, Guidance, etc.).Awareness of evolving regulatory reform initiatives and pending changes (Federal Register, media reports, etc.).
#J-18808-Ljbffr