At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position Responsibilities
• Functions as a process expert for CMC change control in the RIM system. Utilize strong working knowledge of related processes such as labeling revisions and registrations updates.
• Executes operational aspects of assigned regulatory processes to ensure compliance.
• Contribute to a new CMC data quality program, interact with end users, and track problems to closure.
• Execute daily data stewardship activities and is able to identify CMC compliance issues. Inform end-users of defects and issues to be corrected.
• Prepare monthly metrics, assess trends and communicate issues that need escalation.
• At the request of management, prepare data in supports of governance meetings.
• Supports and participates in the development of process optimization
• Manages daily workload in addition to work on process improvements and/or system enhancements
• Provides support for internal audits, HA inspections and participates in the resolution of corrective preventive action plans in defined area of expertise
• Plans and leads small projects including activity/ milestone creation and tracking to completion, communication of progress to key stakeholders and senior leadership, identification of risks and issues.
Working Practices
• Experience with CMC Change Control and labeling processes in a pharmaceutical environment.
• Demonstrates excellentcritical thinking skillsin daily workin alignment with group/company objectives
• Demonstrates an understanding of the procedures and decision-making process of relevant Health Authorities.
• Strong understanding and practical knowledge of regulatory operations
• Regulatory Data Management experience and an understanding of electronic records management rules, including ALCOA+.
• Understanding of system validation / testing, and electronic records regulations. Experienced with computer systems in an R&D environment
• Project management experience managing people in a matrix and estimating resource needs.
• Microsoft office - advanced knowledge of Excel (templates, formulas and macros), PowerPoint and Word
• SQL experience
• Report and dashboard creation experience (Veeva Vault preferred)
• Strong communication and change management skills
• Excellent command of the English language, including the ability to communicate in both written and oral forms.
• Strong presentation skills, including presentation to senior leaders. Able to summarize key messages appropriately for different audiences
• Experience instructing/ training end-users andwith the development of work instructions
Educational Requirements
BS/BA in a relevant scientific or technical field preferred.And4-8 years of pharmaceutical industry experience.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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. management Employment Type: OTHER