Specialist, Global Labeling

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Summary The specialist is responsible for proofreading labeling-related documents, to support the Labeling Operations teams, including but not limited to the CCDS (Company Core Data Sheet) and US, EU and International labeling and artwork documents.   Will represent the assigned countries or region as a Subject Mater Expert as needed in meetings regards change impact assessment, status or implementation for project teams, and if needed during strategy assessments affecting their core product or region. Supporting the Labeling Operations team with Labeling Document Creation. Supports US/EU/ILO teams as per the business need. Duties/Responsibilities Quality review of CCDS and country specific labeling documents (as prescription drug labeling, packaging and submission documents) for US, EU & International markets    Review of documents for accuracy, clarity, and consistency of content and format; correct spelling, grammar, and punctuation  Coordinate and collaborate with internal and external stakeholders to ensure delivery timelines are met  Highlight (for additional review) other non-grammatical inconsistencies observed such as with artwork or layout when proofreading materials  Perform administrative tasks in support of Labeling Operations team, e.g. maintaining files and documentation, updating spreadsheets, coordinating workflows.  Supports US/EU/ILO teams as per the business need. Proactively identifies risks and issues, and develops solutions to challenging areas related to assigned projects / countries in the interest of keeping projects streamlined and moving forward. May work directly with external and global project teams (e.g. Local Regulatory, Global labeling Strategy, International Strategy leads, Artwork Team, Supply Chain and manufacturing operations sites) as required to support the country, region and/or products assigned.    Maintains up-to-date knowledge and understanding of regulatory labeling requirements of assigned region or countries.  Support creation of labeling documents, such as Composition copy, SPL draft word document and annotated document, annual reports, in support of the Labeling teams.   May work under the guidance of the Regional Labeling Operations Lead and serves as a back-up for the Regional Labeling Operations Lead.  Verify language sources from SmPC and USPI for international markets; mark up inconsistencies and escalate to Labeling operation team for review and remediation  Maintain proofreading tracker; enter real-time data on status of proofreading activities  Ensure recent major reference document changes are applied, verify hyperlinks in annotated documents and ensure accuracy of cross references in labeling  Participate and work in team environment, working and communicating on multiple projects and tasks effectively and in a timely manner  Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.  Supporting the