Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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.

Position Summary

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

Key Responsibilities

• Works under the guidance of the US Labeling Operations Lead or with Senior Specialists
• 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. physician\xe2\x80\x99s 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 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.
• 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)

Qualifications & Experience

• Bachelor\xe2\x80\x99s or Master\xe2\x80\x99s degree, preferred in sciences
• \xc2\xb32 years experience in pharma industry (experience in Regulatory/Labeling is a plus).
• Must possess an excellent command of language (English)
• 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
• 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 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.
• Experience creating and updating Structured Product Labeling (SPL) documents. Use of A4L (i4i) software a plus.
• Excellent project management and cross-functional collaboration skills.

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 . 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