Data Analyst - REMS Compliance

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 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: careers.bms.com/working-with-us.

Position Summary

REMS Compliance is responsible for defining, developing, and executing the REMS noncompliance and audit programs, including tracking data and metrics when FDA requires a Risk Evaluation and Mitigation Strategy (REMS) that includes auditing the legal entities providing therapy to patients. REMS Compliance collaborates with Local Market Patient Safety (LMPS) and relevant functions to provide global tracking and oversight of Risk Minimization Programs (RMinP) 3rd Party nonadherence events.

• Subject Matter Expert (SME) for all aspects of REMS and RMinP 3rd party noncompliance and nonadherence data analytics.

• Contributes to the development, implementation, use and improvement of electronic tools used to perform noncompliance, nonadherence, and surveillance activities. Leverages automation and electronic capabilities to streamline processes and enhance operational excellence.  Appropriately increases/enhances electronic enablement.

• Drives continuous process improvement and efficiency by leveraging existing and emerging technology solutions through collaboration with WWPS and IT functions. Contributes to special projects.

• Adopts the BMS Quality Management System (QMS) within the team’s scope and identifies opportunities for 1) increasing operational excellence, 2) continuous improvement, and 3) progressing the maturity model of the BMS QMS.

Duties/Responsibilities

• REMS Compliance electronic system Super User and SME.

• Contributes to validation projects and system testing. Interface with the IT Delivery Team(s).

• Responsible for downloading, visualizing, organizing, and verifying data: 1) required for Health Authority inspections and submissions (such as REMS Assessment Reports and Information Requests), 2) supporting REMS audit and noncompliance programs, 3) supporting RMinP 3rd Party nonadherence programs, and 4) needed to facilitate management oversight.

• Monitors and triages incoming messages to the REMS Compliance and RMinP Compliance shared mailboxes. 

• Responsible for timely (usually same day) responses to requests affecting external REMS participants, such as creating/disabling/updating pharmacy staff profiles in REMS systems, handling password re-sets, managing/improving automated reports, and resolving or escalating systems issues.

• Adopts the BMS QMS by leading the development and implementation of written procedures for data-centric processes, such as preparing and validating data tables, developing yearly audit plan that require risk-ranking sites, etc.

Qualifications

• A minimum of 5 years’ experience using data analysis tools such as Excel, pivot tables, Tableau and/or SpotFire.

• Experience with electronically enabled processes in a regulated environment a plus.

• Experience working with and analyzing large data sets to identify inconsistencies and errors.

• Proven ability to support decision-making by distilling and communicating quantitative information.

• Advocates and propagates the highest standards of quality and compliance.

• Strong time-management, organizational, and problem-solving capabilities. Ability to work independently and to define and set targets for completion of tasks, both as an individual and within a team.

• Demonstrated ability to work in a complex, changing environment and accountable for actions and results.

• Delivers on assign tasks with high standards, high productivity and meeting established standards.

• Demonstrated ability to learn and manage complex electronic systems and to use standard, corporate electronic tools.

• Travel possible to conduct audits in support of business continuity.

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.

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 Protocol

BMS 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

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/

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