Senior Specialist, Medicinal Product Data Management - Bristol-Myers Squibb

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 .

Performs EVMPD maintenance coordination through data collection, data entry and data QC for EVMPD and DMP. Maintains understanding of the assigned EVMPD Processes and IDMP business processes. Manages daily workload and independently addresses questions for assigned regulatory processes. Contributes to enhancements in developed areas of expertise. Provides support for internal audits, HA inspections and corrective action plans. Supports management in developed areas of expertise. Recognizes and reports data compliance issues and how they impact assigned processes. Execute operational aspects of enabled processes according to BMS procedures. Create, update and/or execute new reports in RIM system for any new data entries or updates to existing product data. Collaborate with stakeholders and SMEs to find solutions and rectify any ongoing or potential issues, as needed. Develop working knowledge of global regulatory practices and requirements as they pertain to IDMP and EVMPD Recognizes and reports data compliance issues, and able to derive how they impact assigned processes and other processes. Qualification:

• BA/BS degree, science / technology field preferred.
• 3-5 years of pharmaceutical experience, relevant experience preferred.
• More than 3 years of experience in the management of the Regulatory information of Medicinal products/Vaccines which include performing the data entry and submission through Veeva vault and EV web.
• Solid regulatory knowledge and previous experience in the Regulatory Information Management area
• Clear knowledge and experience with EVMPD, IDMP, and/or SPOR. Possesses knowledge in standard desktop applications and RIM systems, including effective troubleshooting skills.
• Easily adapts to new software and procedures. Strong attention to detail.

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.