Join Bristol Myers Squibb: A Life-changing Opportunity

Challenging. Meaningful. Life-changing. These are not just words but a true reflection of the impactful work you’ll be part of at Bristol Myers Squibb. Experience unique, interesting tasks daily, from optimizing production lines to groundbreaking cell therapy advancements. Here, your work will not only transform the lives of patients but also advance your career.

Grow and thrive with high-achieving, diverse teams through opportunities that are uncommon in scale and scope. At Bristol Myers Squibb, we recognize the importance of balance and flexibility in your work environment, offering a variety of competitive benefits, services, and programs to support your goals both professionally and personally.

Job Opening: Senior Specialist, Medicinal Product Data Management

Functional Area Description

Regulatory Information and Submission Management is responsible for delivering health authority submissions and product data to support the BMS portfolio. This organization sets the strategic business direction and oversees processes for GRS systems.

Position Summary

The Senior Specialist, Medicinal Product Data Management will support the EVMPD (Extended EudraVigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Products) Operations Group. This role involves collecting EVMPD and IDMP data, performing data entry, quality control, and data maintenance to ensure compliance with current regulations and upcoming global regulatory requirements.

Key Responsibilities

• Demonstrate knowledge and experience with EVMPD, IDMP, and SPOR.
• Coordinate EVMPD maintenance, including data collection, data entry, and quality control.
• Maintain an understanding of assigned EVMPD and IDMP business processes.
• Manage daily workload with minimal guidance and address regulatory process questions.
• Contribute to process enhancements in areas of expertise.
• Identify and report data compliance issues and their impacts on processes.
• Create, update, and execute new reports in RIMS for IDMP data entries and updates.
• Gather documentation and participate in dossier reviews for IDMP data collection and RIMS data entry.
• Review and analyze the mapping of BMS List of Values to SPOR and submit requests for new terms.
• Collaborate with stakeholders and SMEs to resolve issues.
• Develop a working knowledge of global regulatory practices related to IDMP and xEVMPD.
• Follow specific standards and processes, identifying gaps when others do not.

Degree and Experience Requirements

• BA/BS degree in science or technology fields preferred.
• 3-5 years of pharmaceutical industry experience preferred.

Key Competency Requirements

• Foundational knowledge of global regulatory practices and submission guidelines.
• Assist in implementing short- and long-term goals within RISM.
• Proficient in English, capable of effective written communication with non-English speakers.
• Basic presentation skills for diverse audiences.
• Ability to execute non-complex projects, prioritize tasks, and maintain attention to detail.
• Communicate project status and updates to relevant stakeholders.

Additional Information

Travel Requirements: Not applicable

Work Environment: No exposure to hazards/disagreeable conditions

Even if the role intrigues you but doesn't perfectly align with your resume, we encourage you to apply. You could be one step away from a career that will transform your life.

Uniquely Interesting Work, Life-changing Careers

With a vision as inspiring as “Transforming patients’ lives through science™,” every BMS employee plays a crucial role in impactful work. We empower each team member to apply their individual talents and perspectives in an inclusive environment, promoting diversity in clinical trials. Our shared values—passion, innovation, urgency, accountability, inclusion, and integrity—bring out the highest potential in each of our colleagues.

On-site and Remote Work Protocol

BMS employs a diverse occupancy structure based on the nature and responsibilities of your role