Job Description

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 rich in diversity. 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. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. Position Summary The International Labeling Operations Specialist will be responsible for providing International Labeling process oversight and project management, from labeling submission planning to post-approval activities. Key Responsibilities Works under the guidance of the Regional Labeling Operations Lead or with Senior Specialists. Prepares and delivers accurate, consistent, timely, and compliant country-specific HA submission-ready labeling documents in support of safe and effective use of BMS products for in-scope countries. Executes and delivers accurate, consistent, timely, and compliant country-specific post-approval activities in support of safe and appropriate use of BMS products for in-scope countries. Creates composition copies, reviews and approves printed artwork for new and revised artwork, and assists with timely implementation of the updated artwork per BMS policy and per local regulations. Reviews, maintains and tracks required labeling and artwork documents (e.g. physician\'s label, patient insert, carton, label, blister, tenders) using BMS software, systems, tools. Works 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. Supports Labeling related ad-hoc activities. Maintains up-to-date knowledge and understanding of regulatory labeling requirements of assigned region or countries. 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. Supports and develops to the Senior Specialist scope of work (gains Subject Matter Expert on country labeling) Elevates risks and issues, and participates in solutions development to challenging areas related to assigned projects / countries in the interest of keeping projects streamlined and moving forward. Qualifications & Experience Bachelor\'s or master\'s degree, preferred in sciences. 2 years experience in a regulated environment in pharma industry (Labeling is a plus). Must possess an excellent command of language (English) Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar willing to learn additional applications as needed Experience formatting and editing labelling documents in MS Word and Adobe Acrobat. Ability to troubleshoot complex document issues. Proven ability to verify developed label content against source documents relying upon proofreading skills and electronic tools (include TVT and Global Vision preferred). Past experience working with artwork management systems and process flows preferred. Experience working with Veeva Vault, CARA, or similar is a plus. Experience working on multi-disciplinary teams and projects Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control) Other Qualifications Basic knowledge of labeling regulations and HA approval structure of assigned region or countries. Good communication and organizational skills and a meticulous eye for details Good understanding of pharmaceutical or medical terminology The ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline Knowledge/ understanding of another language in a region supported #HYDDD If you come across a role that intrigues you but doesn\'t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as \'Transforming patients\' lives through science \', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [HIDDEN TEXT]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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