Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: .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.Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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:Position Summary

• The US/EU Labeling Senior Specialist will be responsible for ensuring accuracy, consistency, and alignment of Bristol-Myers Squibb labeling with the FDA/EMA Regulations and BMS Policy. Some key aspects of this role include document preparation for various FDA/EU submissions, post-approval activities and reporting metrics.

Key Responsibilities

• Works under the guidance of the US/EU Labeling Operations Lead.
• Supports EU Labeling on Centrally Approved Products, National procedures, EU regulatory labeling requirements, knowledge of Quality Review of Documents (QRD).
• 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.
• Subject Matter Expert on US Labeling, in order to support and advise Global Regulatory, Global Labeling Leads and any other affected teams on Labeling impact / labeling change control / potential labeling issues or complexity.
• Supports compliance for labeling activities, local and region specific audits including but not limited to labeling responses during audit or HA query, inspections, labeling Corrective and Preventive Actions (CAPA), and continuous improvement.
• 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.
• Able to train new staff and mentor development through direct knowledge and experience.
• Prepares and delivers accurate, consistent, timely, and compliant FDA submission-ready labeling documents in support of safe and effective use of BMS products, per FDA and BMS standards (including markups and clean Labeling documents, annual reports, SPL and eCTD documentation).
• Supports global labeling leads in creation of submission-ready labeling documents.
• Collaborates with contributing functional areas and external sources to verify accuracy of submission labeling components in the required formats. Executes and delivers accurate, consistent, timely, and compliant US-specific post-approval activities in support of safe and appropriate use of BMS products for the US.
• Creates, reviews and approves printed package components for new and revised artwork and assists with timely implementation of the updated artwork per BMS policy and per local regulations.
• Works closely with graphics department to create and revise package insert, carton and container copy utilized for FDA submissions.
• Reviews, maintains and tracks required labeling and artwork documents (e.g. physicians label, patient insert, carton, label, blister) using BMS software, systems, tools.
• Works directly with external and global project teams (e.g. US Regulatory functions, Global labeling Strategy, Artwork Team, Supply Chain and manufacturing operations sites) as required to support the country, region and/or products assigned.
• The US Labeling Senior Specialist will manage critical stakeholder labeling communications and activities, ensuring timely and accurate implementation of product labeling for US launches and ongoing compliance requirements, recognizing that the US is a priority market for BMS.
• Supports Labeling related ad-hoc activities.
• Maintains up-to-date knowledge and understanding of FDA regulatory labeling requirements.

Qualifications & Experience

• Bachelors or Masters degree, preferred in sciences
• \xc2\xb34 years experience in US/EU Labeling experience is preferred.
• Must possess an excellent command of language (English). Experience formatting and editing labelling documents in MS Word and Adobe Acrobat. Ability to troubleshoot complex document issues.
• Good communication and organizational skills and a meticulous eye for details
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed
• Experience working on multi-disciplinary teams and projects
• 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
• Proven ability to verify developed label content against source documents relying upon proofreading skills and electronic tools to include TVT and Global Vision.
• Past experience working with artwork management systems and process flows preferred.
• Experience working with Veeva Vault, CARA, eCTD viewers, or similar tools.
• Experience creating and updating Structured Product Labeling (SPL) documents. Use of A4L (i4i) software a plus.
• Excellent project management and cross-functional collaboration skills.

*Direct BMS experience may be considered instead of Labeling experience/ college degree/ managerial experience.If you come across a role that intrigues you but doesnt 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.#HYDDD #LI-HybridIf you come across a role that intrigues you but doesnt 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 ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.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 . Visit 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.

Bristol-Myers Squibb