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Job Description
The Director, MLR Excellence & Digital Enablement leads BD's transformation of Medical, Legal, and Regulatory (MLR) review through the integration of digital platforms, AI-enabled solutions, and standardized global processes. Responsible for advancing MLR efficiency, compliance, and scalability by driving technology adoption, workflow optimization, governance, and data-driven decision-making across the enterprise.
The Director will own the process standard itself. That means the SOPs, the cycle-time and quality metrics, the dashboards that make rework visible to business unit and regional leadership, and the root-cause analysis that tells us where the time actually goes before anyone redesigns anything. Regional adoption is a crucial part of the job: the measure of success is that regions use the central capability instead of building local equivalents.
The Director partners across Marketing, Legal, Regulatory, Medical, and Commercial teams and operates as a global center of excellence leader, enabling consistent ways of working across Businesses and Regions.
Success Profile
- Own BD's global end-to-end MLR process standard, spanning content review and approval, localization and translation, and in-region and in-country approval, together with the operating documentation behind it.
- Autonomous approval running in production for low-risk content categories, with the rules, thresholds, audit trail, and signature handling agreed with Regulatory Affairs and operating across regions.
- A 90% reduction in the overall approval timeline from content creation to in-market approval, measured against a published baseline.
Key Responsibilities
- Define and execute the MLR technology and process roadmap, aligning business requirements with regulatory and compliance objectives.
- Lead implementation and continuous optimization of AI-enabled content review, automation, and workflow management solutions.
- Establish and govern standardized MLR processes, operating procedures, metrics, and performance dashboards across business units and geographies.
- Drive process harmonization, simplification, and continuous improvement to reduce cycle times while maintaining compliance and quality standards.
- Partner with Regulatory, Legal, Medical, IT, and Marketing stakeholders to enhance end-to-end content approval workflows and user experience.
- Leverage data analytics and process intelligence tools to identify bottlenecks, monitor performance, and accelerate review effectiveness.
- Champion emerging technologies, including generative AI, machine learning, workflow automation, and digital collaboration platforms to modernize the MLR ecosystem.
- Build organizational capabilities in digital fluency, AI adoption, process excellence, and change management.
Skills and Competencies
- MLR governance, compliance, and operational excellence
- AI and advanced automation technologies
- Workflow and business process design
- Data analytics and process intelligence
- Digital product and platform management
- Change leadership and technology adoption
- Agile delivery and continuous improvement
- Cross-functional stakeholder management
Education, Qualifications, and Experience Education
- Bachelor's degree required
- MBA or advanced degree preferred
Qualifications
- 10+ years of experience in marketing or marketing operations within MedTech, pharmaceutical, biotechnology, or other regulated healthcare environments.
- Direct experience in Medical, Legal, and Regulatory (MLR) review, regulatory affairs, or compliant marketing operations, with hands-on expertise in Veeva PromoMats or a comparable promotional review system preferred.
- Proven track record of improving promotional review efficiency, quality, and compliance outcomes.
- Demonstrated expertise in process mapping, workflow design, root cause analysis, and continuous improvement within compliance-driven processes.
- Proven experience implementing technology and AI solutions within regulated marketing environments, including the organizational change management required to drive adoption and sustained impact.
- Demonstrated success designing, building, or deploying AI-enabled workflows, intelligent automations, assistants, or agents that deliver measurable business value, coupled with sound judgment regarding appropriate and effective AI use cases.
- Strong analytical mindset with the ability to leverage data to optimize processes, influence decision-making, and confidently present recommendati