BioSpace
Sr. Director – US Regulatory Advertising/Promotion Therapeutic Lead (Oncology)
BioSpace, 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
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.
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: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Staffing and People Development
Coaches staff 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 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
Support 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. Provides input into salary administration and promotion recommendations, talent assessment, and succession planning discussions for reporting staff members.
Provides frequent reinforcement, coaching or feedback to staff. Actively supports staff to share any new learning. Participates in and promotes reward and recognition.
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.
Provide coaching and oversight for contracted regulatory personnel supporting therapeutic area
Provide effective leadership and regulatory expertise to US Business Unit
Support 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.
Attend US Business Unit meetings and participate actively in making recommendations regarding proposed promotional activity plans
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
Establish effective collaborative relationships with Regulatory leadership at alliance partner company(ies), as applicable
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 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
Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions
Developing an understanding regarding the background of regulatory and marketing history of applicable products in all US Business Units
Attending internal and external training programs, such as staff meetings, town halls, DIA, FDLI and RAPS meetings.
Encourage staff to share lessons learned in forums such as GRA staff meetings
Lead/Influence/Partner
Exemplify 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 communicate 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
Participate in forums that share regulatory information across GRA components and 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
Serve 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.)
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 ( Lilly_Recruiting_Compliance@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.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
#J-18808-Ljbffr
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.
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: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Staffing and People Development
Coaches staff 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 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
Support 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. Provides input into salary administration and promotion recommendations, talent assessment, and succession planning discussions for reporting staff members.
Provides frequent reinforcement, coaching or feedback to staff. Actively supports staff to share any new learning. Participates in and promotes reward and recognition.
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.
Provide coaching and oversight for contracted regulatory personnel supporting therapeutic area
Provide effective leadership and regulatory expertise to US Business Unit
Support 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.
Attend US Business Unit meetings and participate actively in making recommendations regarding proposed promotional activity plans
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
Establish effective collaborative relationships with Regulatory leadership at alliance partner company(ies), as applicable
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 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
Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising decisions
Developing an understanding regarding the background of regulatory and marketing history of applicable products in all US Business Units
Attending internal and external training programs, such as staff meetings, town halls, DIA, FDLI and RAPS meetings.
Encourage staff to share lessons learned in forums such as GRA staff meetings
Lead/Influence/Partner
Exemplify 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 communicate 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
Participate in forums that share regulatory information across GRA components and 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
Serve 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.)
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 ( Lilly_Recruiting_Compliance@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.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
#J-18808-Ljbffr