Manager I, EU Labeling Management

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. 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.

Position Summary

The EU Labelling Operations Manager will be responsible for providing EU Labelling process oversight and project management, from labelling submission planning to post-approval activities.

• Prepare and deliver accurate, consistent, timely labelling documents for submissions to EMA (European Medicine Agency) and artwork creation per EMA Regulations and BMS Policy requirements.
• Provide support to the ERPSs for labelling and other ad-hoc activities, in order to ensure timely regulatory submissions/approvals, timely availability of updated artworks and EMA Certificates.

Duties/Responsibilities

• Work independently and be able to train/ mentor junior staff. 
• Maintain up-to-date knowledge of EU regulatory labelling requirements, communicating impact on BMS business and products.
• Provide support to the labelling activities of the Centrally Approved Products.
• Coordinate external requests for data related to labelling and artwork with professionalism and adherence to policy and regulations.
• Prepare and distributes EU labelling submission documents and labelling related documents that meet EMA and BMS internal standards. 
• Provide oversight and project management related to the planning and execution of EU Labelling operational activities.
• Liaise with Readability Testing company to monitor progress of new and ongoing tests.
• Ensure high quality and accuracy of all labelling 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 labelling process to minimize the risk and associated costs to BMS and patients of a significant error occurring in final labelling preparations that results in a product delay or recall due to labelling.
• Elevate 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

Specific Knowledge, Skills, Abilities:

• 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.

Education:

• A degree preferred in science with 3 years’ experience in Pharmaceutical industry*
• Direct regulatory or labelling experience in a regulated environment

Experience:

• 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 Labelling regulations and standards is a plus.
• Experience in quality control of documents in different languages and format.
• Experience of working on demanding translation projects managed in team and autonomously.
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; willing to learn additional applications as needed.
• Professional knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)

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.

Warsaw - PL: zł173,780 - zł210,584

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601867 : Manager I, EU Labeling Management