Associate / Sr Associate/ Manager - Regulatory Labeling

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

The role

The purpose of the Labeling Associate role in the Global Labeling Department at Cork is to lead the development and maintenance of Core labeling documents and provide oversight of global implementation for drug and combination device products. The Associate leads the development of United States (US) and Canada packaging and combination device patient labeling. The Associate serves as the primary interface with the Printing Packaging Development (PPD) organization for implementation of US and Canada labeling. The Associate drives consistency in labeling processes and operations.

Primary Responsibilities:

1. 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.

2. 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.

3. 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.

4. 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).

Knowledge of the drug development process.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

€39,750 - €87,560

Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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