About the Role
The Associate Director is a key member of our Global Labeling Department, responsible for leading the development and maintenance of Core labeling documents. This role requires strong leadership and collaboration skills, with the ability to drive consistency in labeling processes and operations.
Job Description
We are seeking a highly skilled and experienced professional to lead the development and maintenance of US and Canada packaging and combination device patient labeling. As an Associate Director, you will be responsible for developing and maintaining Core labeling documents, including Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content. You will also serve as the primary interface with the Printing Packaging Development (PPD) organization for implementation of US and Canada labeling.
Key Responsibilities
* Lead the development and maintenance of Core labeling documents, including CDS, CDL, and CMC Core Labeling Content.
* Serve as the primary interface with PPD organization for implementation of US and Canada labeling.
* Develop and maintain US and Canada packaging for Lilly drug and combination device products.
* Lead the development and maintenance of US and Canada combination product patient labeling, including Instructions for Use (IFU) and Quick Reference Guide (QRG).
Requirements
To be successful in this role, you will need a Bachelor's degree in a scientific or health sciences discipline, with at least 5-8 years of industry-related experience in regulatory affairs and/or drug development. You should have excellent communication and leadership skills, with the ability to collaborate effectively with business partners and stakeholders.
Benefits
We offer a range of benefits, including flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Our holistic benefits package includes In-house People Development services, Educational Assistance, and 'Live Your BEST Life' wellbeing initiatives, which enhance the career experience for our colleagues.
Join Our Team
We are a global healthcare leader, headquartered in Indianapolis, Indiana. We unite caring with discovery to make life better for people around the world. If you are a motivated and results-driven professional, who is passionate about making a difference, we encourage you to apply for this exciting opportunity.