International Labeling Operations Senior Specialist
3 weeks ago
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: .
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.
- The International Labeling Operations Senior Specialist 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.
- Works under the guidance of the Labeling Operations Lead and serves as a back-up for the Labeling Operations Lead.
- 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.
- Subject Matter Expert on country labeling, in order to support and advise Global Regulatory, International Submission and all 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.
- Bachelor's or master's degree, preferred in sciences.
- 34 years experience in a regulated environment in pharma industry (Labeling is a plus).
- Must possess an excellent command of language (English)
- Ability to read Spanish will be preferred.
- Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities
- 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
- Professional knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)
- Solid knowledge of labeling regulations and HA approval structure of assigned region or countries.
- Excellent 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 in the pharmaceutical and scientific documentation discipline
- Experience in the complexities of ROW (Rest of World) labeling requirements when a source or reference label is followed.
- Knowledge/ understanding of another language in a region supported
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 scienceTM , 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.
#HYDDD #LI-Hybrid
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 scienceTM , 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
BMS 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 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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