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Job Description

The RA Labeling Compliance and Business Solutions Lead will partner with labeling teams, stakeholder groups, and leadership in assessing new challenges and helping to identify and implement solutions.

This role reports to BD’s Central Regulatory Affairs team and provides the RA Labeling Compliance and Business Solutions Lead the platform to support BD as the Global Process Owner for eIFU. In addition to being accountable for management of BD’s eIFU website solution, this role is responsible for supporting the onboarding of new BD business units to the eIFU site, supporting ongoing solution compliance and site use, and identifying new, related, opportunities. Additional BD-wide labeling responsibilities include supporting the development, deployment, and management of BD-wide labeling software solutions, and engagement with all labeling teams to identify areas of opportunity and to bring the Voice of Regulatory to system and process improvements within the product labeling space.

The ability to socialize change to upstream and downstream stakeholders is essential; additional responsibilities include utilizing problem-solving skills to support the processes governing labeling solutions, identifying, and monitoring labeling metrics, and building and supporting BD’s internal labeling communications network. This position reports directly to the Director, Central Regulatory Affairs.

Job Responsibilities:

• Global Process Owner of BD’s eIFU solution; helps identify data quality/integrity risks and resolve/escalate as appropriate, administers, and ensures functional policies and procedures are followed, and oversees Power User forums and Change Control Board Meetings.
• Support of existing and developing BDX labeling technology platforms, including monitoring the onboarding of BD businesses to those solutions and participating in identifying/implementing/validating system enhancements.
• Continuous development of expertise in labeling regulations and processes across BD to provide both advisement and support of labeling deliverables, initiatives, and challenges.
• Owns BD-wide labeling policies and procedures, as applicable.  
• Regular review of Labeling systems and processes to ensure optimization and alignment of regulatory, quality, and business requirements.
• Identification/evaluation of new labeling technology solutions, based on business need. Participate/lead new projects to ensure implementation success, support BD Business Units onboarding to BDX Labeling platforms.
• Review and assessment of any new/updated regulations impacting BD product labeling. Engagement of key stakeholders in driving/facilitating incorporation of any resulting procedure and policy updates.
• Regular communication with labeling stakeholders and high-level monitoring of labeling activity throughout BD, with the goal of identifying trends, shared issues, and best practices. Collaboration with various internal functions to troubleshoot issues as they arise as well as leading solutions to resolve.
• Assess stakeholder feedback and accurately summarize with an eye toward business impact, identify and communicate resulting risks, challenges, and opportunities to leadership.
• Appropriate escalation when existing processes may not align with new requirements, and ability to inspire labeling stakeholders in building solutions.
• Builds and applies business acumen to identify relevant labeling metrics; supports regular reporting.
• Reports on key project plans, activities performed, and any obstacles.

Leadership Expectations:

• Ability to create a sense of energy, excitement, and personal commitment to the organization by empowering others, rewarding, and celebrating superior performance, and creating an inclusive workplace across multiple locations.
• Be an advocate for Regulatory Labeling; communicate confidently with peers, subordinates, and superiors. Skilled in distilling critical information and delivering simple, clear messaging.
• Coordinate with peers across BD to establish, communicate, and engage them in the vision & strategy of labeling initiatives, and build consensus for process harmonization.
• Establish, build, and successfully manage relationships with partners in stakeholder organizations.