Labelling Specialist

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.