Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: .Functional Area DescriptionRegulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems.Position SummaryThe Sr. Specialist, Medicinal Product Data Management supports the EVMPD (Extended EudraVigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Products) Operations Group. This role will also support future MPDM health authority data requirements and deliverables.This role will collect EVMPD and IDMP data, perform data entry, QC, and data maintenance support to maintain compliance with current EVMPD regulations and to meet upcoming global regulatory requirements for submission of IDMP data based on local implementation guides.Position ResponsibilitiesDemonstrates knowledge and experience with EVMPD, IDMP, and SPOR.Performs EVMPD maintenance coordination through data collection, data entry and data QC for EVMPD, when required.Maintains understanding of the assigned EVMPD Processes and IDMP business processes.Manages daily workload and addresses questions for assigned regulatory processes with minimal guidance.Contributes to enhancements in developed areas of expertise.Recognize and report data compliance issues, and is able to derive how they impact assigned processes and other processes.Create, update and/or execute new reports in RIMS for any new data entries or updates to existing product data for IDMP with strong attention to detail.Gather appropriate documentation and participate in dossier (Mod 3) reviews required for IDMP data collection and RIMS data entry to support Global Product Supply (GPS).Review and analyize the mapping of BMS List of Values to SPOR and submit requests for new required terms when applicable.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 xEVMPD.Demonstrated ability to follow specific standards and processes and ability to identify when others do not.Degree RequirementsBA/BS degree, science / technology field preferredExperience Requirements3-5 years of pharmaceutical experience, relevant experience preferred.Key Competency Requirements

• Foundational knowledge of global regulatory practices, submission guidelines and requirements.

• Assists in the implementation of short- and long-term goals within own work group within RISM.
• Comes prepared with a solution to questions and issues as they arise.
• Engages relevant stakeholders to help address the problem.

• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
• Demonstrates basic presentation skills needed to deliver content to a variety of audiences.

• Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.
• Communicates project status and updates, as appropriate, to relevant stakeholders.

Travel Required (nature and frequency).Not applicableDescribe exposure to any hazards/disagreeable conditions in the work environment.Not applicableIf you come across a role that intrigues you but doesnt 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 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 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 ProtocolBMS 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 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.

Bristol-Myers Squibb