Medical and Regulatory Affairs
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Position Summary / Objective
This will be an evolving role supporting the business in evaluation of capabilities and business processes necessary across the enterprise in order to meet upcoming global regulatory requirements for submission of IDMP (Identification of Medicinal Products) data based on local implementation guides. This includes preparing for the first implementation project, from tool selection to data readiness and everything in between. The role needs to take into account both the internal and external environment and requirements, and serves as the BMS process and requirements expert for the future capability (IDMP).
The role will serve as a co-lead on one of the areas of data remediation and/or the business implementation workstream. The role will also assist in data quality/compliance activities. After EMA IDMP go live, this role will transition into management of the IDMP data quality activities.
Maintains comprehensive knowledge of the assigned regulatory processes with multiple areas of expertise
Supports and participates in the development of process optimization, manages daily workload and serves as a process expert assigned processes
Contributes to process implementations and/or system enhancements in developed areas of expertise
Provides support for internal audits, HA inspections and participates in the resolution of corrective preventive action plans in defined area of expertise
At the request of management, prepares data in supports of governance meetings, and contributes to resulting initiatives in developed areas of expertise
Executes daily data stewardship activities and is able to identify compliance issues for assigned processes
Executes operational aspects of assigned regulatory processes to ensure compliance
BS/BA in a relevant scientific or technical field preferred. Additional experience may be considered in lieu of a degree.
Minimum of 2 years work in Regulatory Affairs or minimum of 3 years of pharmaceutical industry experience
Experience with EVMPD and/or IDMP preferred
Key Competency Requirements
Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives
Demonstrates some understanding of the procedures and decision-making process of relevant Health Authorities.
Strong understanding and practical knowledge of regulatory operations
Knowledge and some experience with computer systems in an R&D environment
Understanding of electronic records management rules
Contributes to projects and understands how to communicate and interact with internal and external customers
Good understanding of desktop application software suites
Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills.
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 the resources to pursue their goals, both at work and in their personal lives.