Job Summary
We are looking for a skilled and experienced Associate Director to lead the development and maintenance of Core labeling documents and provide oversight of global implementation for drug and combination device products. The successful candidate will have strong leadership skills, excellent communication abilities, and a deep understanding of regulatory requirements.
Primary Responsibilities:
* Core Labeling Development and Maintenance:
• Lead the development and maintenance of Core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content].
• Lead the preparation activities and facilitate approval of Core labeling by the Global Product Labeling Committee for CDS and CDL and Global Labeling Council for CMC CLC.
• Communicate initial and revised Core labeling to global affiliates and provide support and consultation, as necessary.
* US and Canada Labeling Development and Maintenance:
• Lead the development and maintenance of US and Canada packaging for Lilly drug and combination device products.
• Lead the development and maintenance of US and Canada combination product patient labeling [i.e., Instructions for Use (IFU) and Quick Reference Guide (QRG)]. Serve as primary liaison with the Device Delivery & Connected Solutions (DDCS) organization.
• Lead the development and maintenance of Clinical Trial IFUs.
• Demonstrate in-depth understanding of content, format, and style requirements for labeling documents including local regulations, guidance, and trends.
• Conduct data integrity reviews of healthcare provider labeling in partnership with GRA-NA Clinical Regulatory.
• Serve as primary liaison with PPD organization for implementation of US and Canada labeling.
• Serve as primary liaison with DDCS and PPD organizations for development of labeling artwork.
• Communicate initial and revised US and Canada labeling to global affiliates and provide support and consultation, as necessary.
• Lead labeling contributions for periodic reporting (e.g., FDA Annual Report, Periodic Safety Update Report, Periodic Benefit/Risk Evaluation Report, Development Safety Update Report) in collaboration with GRA-NA Clinical Regulatory.
• Coordinate the translation of labeling documents with vendors.
* Labeling Expertise and Process Excellence:
• Provide Regulatory input and guidance on Core labeling and US and Canada labeling specific to packaging and IFUs.
• Manage Core labeling exception requests from affiliates and facilitate approval from leadership.
• Perform periodic labeling assessments to assess compliance of affiliate product information with Core labeling.
• Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes.
• Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.
• Maintain the end-to-end labeling system for Core, US, and Canada labeling.
• Develop, update, maintain, and archive labeling documents utilizing appropriate tools, systems, and version control.
• Plan, track, and record labeling submission and approval activities using the appropriate tools and systems.
* Lead/Influence/Partner:
• Exemplify the Team Lilly behaviors of Include, Innovate, Accelerate, and Deliver.
• Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.
• Collaborate effectively with business partners and stakeholders.
Minimum Qualification Requirements:
* Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
* Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 5-8 years.
Additional Preferences / Other Information:
* Regulatory experience. Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory reform initiatives related to combination products.
* Ability to apply therapeutic expertise.
* Project Management experience.
* Demonstrated ability to lead, influence and partner.
* Demonstrated communication skills: writing, presenting, listening.
* Demonstrated effective teamwork skills; ability to adapt to diverse interpersonal styles and working across geographies.
* Demonstrated attention to detail and organizational skills.
* Ability to learn and use new software/technology.
* Ability to manage strategic and operational tasks.
What We Offer:
* Competitive compensation and benefits package.
* Opportunities for professional growth and development.
* Diverse and inclusive work environment.
EEO Statement:
Lilly is an equal employment opportunity employer. We do 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.