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 EU Labeling Operations Specialist will be responsible for providing EU Labeling process oversight and project management, from labeling submission planning to post-approval activities. Prepare and deliver accurate, consistent, timely labeling documents for submissions to EMA (European Medicine Agency) and artwork creation per EMA Regulations and BMS Policy requirements. Provide support to the ERPSs for labeling and other ad-hoc activities, in order to ensure timely regulatory submissions/approvals, timely availability of updated artworks and EMA Certificates. Key Responsibilities with professionalism and adherence to policy and regulations. Prepare and distributes EU labeling submission documents and labeling related documents that meet EMA and BMS internal standards. Provide oversight and project management related to the planning and execution of EU Labeling operational activities. Ensure high quality and accuracy of all labeling for dissemination to wide and critical audiences. Provide support to the ERPSs for labelling and other ad-hoc activities Coordinate the process for providing translations of Product Information (PI) in multiple languages (centralized procedure) within strict European Medicine Agency (EMA) procedural timelines. Coordinate translation, review, submission to Member States (MS), discussion of MS\'s proposed changes and final submission of language PIs to EMA. Perform quality control of language PIs ensuring compliance with EN PI and language-specific Quality Review of Documents (QRD) templates/guidelines and terminology consistency within language PI/across other approved PIs. Gather information required to develop/update printed packaging components (artworks). Initiate, coordinate and track the artwork updates and approvals. Coordinate and complete Artwork Requests and Implementation Plans. Interact with Local Regulatory, Artwork teams, Supply Chain and manufacturing operations sites. Comply with the EU end-to-end labeling process to minimize the risk and associated costs to BMS and patients of a significant error occurring in final labeling preparations that results in a product delay or recall due to labeling. Qualifications & Experience A degree preferred in science 2 years experience in Pharmaceutical industry preferred Direct regulatory or labeling experience in a regulated environment is a plus Must possess an excellent command of language (English). Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities is a plus Solid understanding of EMA Regulatory and Labeling regulations and standards is a plus Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar willing to learn additional applications as needed. Good communication and organizational skills and a meticulous eye for details. The ability to work as part of a team that supports global functions with a high level of professionalism. Knowledge/ understanding of another language in the 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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