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.
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.
Labeling Knowledge
Demonstrate in-depth understanding of format and style requirements for labeling documents including regulations and trends.
Develop, update, maintain, and archive labeling documents utilizing appropriate tools, systems, and version control.
Coordinate the review and approval process for labeling documents.
Coordinate the translation of labeling documents with vendors, as necessary.
Understand and execute instructions included in FDA and Health Canada communications. Coordinate required activities with GoLD Associate and GRA-NA Clinical Regulatory Scientist as needed.
Prepare labeling documents for posting to internal and external sites as required.
Plan, track, and record all steps of labeling submission and approval activities using the appropriate tools and systems.
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 Scientist.
Process and System Expertise
Serve as a resource or subject matter expert for labeling-related templates, tools, and computer applications.
Partner with the US and Canada Regional Labeling Coordinator (RLC) to complete project tasks in the artwork management system.
May serve as process subject matter expert for US Structured Product Labeling (SPL), Canada Structured Product Monograph (SPM), eDrug Listing, and provide oversight of external vendor for SPL/SPM conversions.
May assist with labeling-related governance meetings [i.e., Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC)] including pre-read compilation, maintenance of collaboration sites, calendar management, capturing attendance, and documentation management.
May partner with Regulatory Management on Establishment Fee and User Fee activities.
May perform duties of the Regulatory Internet Coordinator (RIC) to post labeling to appropriate websites and maintain records of posted versions.
May maintain GoLD-owned SharePoint Sites with a focus on keeping content current and recommending/implementing site changes.
May be responsible for monitoring and reporting GoLD metrics.
Advise and Influence
Train, mentor, advise, and support less experienced personnel.
Review or QC work of others.
Share labeling knowledge with GoLD team and key customers. Participate in internal working groups to make recommendations that may shape the regulatory labeling environment.
Develop and communicate expertise in labeling regulations and trends related to format, style, packaging, labeling changes, and periodic reports.
Utilize labeling expertise and project management skills to plan and execute a work strategy that enables teams to achieve on-time submissions.
Positively impact regulatory projects and initiatives through active participation in process improvement projects, drafting/reviewing procedures, and problem solving.
Work-Team Collaboration:
Collaborate effectively with GoLD Associate, US and Canada RLC, Regulatory Scientists, Printing Packaging & Development, and other functional stakeholders.
Partner with supervisor and team members to prioritize work and quickly address challenges and mitigate roadblocks.
Be accountable and hold team members accountable to execute quality results in given area of responsibility.
Minimum Qualification Requirements:
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.
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