Associate Director - Labeling Implementation (North America)

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.

Purpose

The purpose of the Associate Director/Director, Global Regulatory Affairs (GRA), Labeling Implementation (M2/M2-2) role is to provide direction, leadership, and technical/process expertise to the associates supporting United States and Canada labeling development, implementation, and maintenance for Lilly products. This position provides strategic input, focuses on results, thinks critically, and emphasizes and drives cross-functional team collaboration to the achievement of goals and objectives.  

The Associate Director/Director, GRA, Labeling Implementation (M2/M2-2) is responsible for appropriate resourcing, staff development and performance management and accountable for completion of labelling activities and identification and implementation of process improvements. 

Primary Responsibilities

Personnel Management and Leadership 

• Provide leadership and direction to staff regarding departmental policies, organizational goals, objectives, performance management and company policies. 

• Hold individuals accountable for achieving goals and implementing the appropriate GRA labeling competency model. 

• Actively coach and mentor staff. 

• Ensure staff members receive appropriate training to perform their jobs. 

• Empower individuals to make logical decisions, resolve issues, and execute tasks. 

• Assure appropriate individual and team recognition. 

• Support individual technical growth and development. 

• Liaise with management colleagues to ensure coordinated and consistent approach to personnel management. 

Strategic Planning and Implementation 

• Align labeling implementation strategy with corporate directives and affiliate (US and Canada) priorities. 

• Actively seek out information on the needs of internal and external customers. 

• Collaborate with business partners and management to evaluate and support priorities. 

• Drive continued improvement and simplified work practices. 

• Participate on management teams in implementation of mission, vision, strategic intent, budget, policies, procedures and practices. 

• Participate in business planning efforts. 

Staffing 

• Successfully allocate staff and manage resources. 

• Provide ongoing assessment of workloads to assure balanced and maximum efficiency of individual talent and capacity. 

• Provide necessary resource support for key projects. 

• Recruit, hire, and effectively “on-board” and integrate new staff to meet current and future needs by understanding and anticipating required future skills. 

• Build and maintain relationships with management in relevant areas. 

• Participate in supporting cross-functional activities/projects about labelling as well as the broader regulatory organization. 

Facilitate Labelling Process 

• Remove barriers to ensure labelling activities are completed accurately, timely, and in compliance with regulatory and quality system requirements. 

• Provide strategic guidance to staff on regulatory and labelling process questions. 

• Monitor labelling regulations and the external environment as appropriate. 

• Maintain familiarity with divisional projects and issues. 

• Provide technical, administrative, and operational support for labelling-related systems and tools (for example, System Ownership, Business Process Subject Matter Expert, Business Integrator). 

Minimum Qualification Requirements

• Bachelor’s degree

Other Information/Additional Preferences

• Prior Management experience 

• Degree in a scientific or health sciences discipline preferred

• Demonstrated ability to work in a global environment 

• Demonstrated ability to communicate effectively (verbally and written), and to motivate and inspire others. 

• Demonstrated flexibility and strong negotiation skills 

• Experience in interpreting and applying regulations 

• Knowledge of drug development process 

• Ability to manage multiple projects/people simultaneously 

• Project management experience 

• Ability to influence and lead 

• Effective interpersonal skills 

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.

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