Astellas Pharma Inc logo

Process Enablement Expert

Astellas Pharma Inc
  • Northbrook, IL
    30+ days ago

    Job Description

    About Astellas

    Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

    Are you driven to make a real difference in the lives of patients?

    We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

    Purpose and Scope:

    The Process Enablement Expert serves as the critical link between MLR technology platforms, global processes, and the teams who create and approve content. This role is responsible for developing, embedding, and monitoring global MLR standards and governance to ensure repeatable, compliant execution and measurable value delivery across Astellas.

    The scope of this role spans regions and geographies, with significant impact on the global content operating model. The role is accountable for MLR process integrity, governance oversight, documentation, and enablement, ensuring that process standardisation drives efficiency, risk reduction, predictability, and operational value. The role also acts as a key contributor and subject-matter partner to Content Enablement led solutions (including MLR AI), ensuring solutions are compliant, scalable, embedded into BAU operations, and deliver tangible business value.

    This role sits within the Content & Channel Enablement Chapter, contributing deep process and governance expertise to enable scalable, compliant content operations across the organisation. As part of this chapter, the Process Enablement Expert plays an active role in the Content Foundations Value Team, partnering closely with Content & Channel Enablement, technology, and operations to ensure foundational processes deliver measurable business value. Through this value‑team model, the role focuses not only on process integrity and compliance, but on VALUE delivery- driving efficiency, reducing risk, improving predictability, and enabling sustainable reuse and scale across our content operations

    Responsibilities and Accountabilities:

    Global MLR Process Ownership & Value Enablement

    Own the design, implementation, and evolution of global MLR processes, ensuring they are simplified, standardized, and scalable across regions and Affiliates.

    Establish and maintain end-to-end MLR process standards, including Build, Re-approval, PI etc.

    Ensure global processes directly support value delivery, including reduced cycle times, improved compliance outcomes, and lower rework.

    Act as the global process authority, resolving ambiguity, fragmentation, and regional deviation in ways of working.

    Governance Frameworks, Monitoring & Risk Reduction

    Own global MLR governance frameworks and monitoring mechanisms.

    Lead prioritization and management of high-risk materials and escalation decisions.

    Lead monthly monitoring read-outs and translate observations into corrective actions.

    Oversee verification and closure of low and mid-risk observations.

    Drive corrective actions addressing systemic risk drivers.

    Operational Monitoring, Data & Value Insights

    Own interpretation and oversight of MLR operational and monitoring data.

    Translate insights into governance decisions and process improvements.

    Lead identification and management of non-AFU materials.

    Coordinate remediation or cancellation actions with Document Owners and PALs (PromoMats/Vault Medical).

    Produce evidence-based summaries and visual outputs to demonstrate value delivery.

    Documentation, SOP & Policy Lifecycle Management

    Own lifecycle governance of global MLR SOPs, Policies, and STLs.

    Partner with LMS team to update MLR SOPs and POLs in LMS and associated training materials

    Govern process-related change requests across Vault Quality in alignment with system owner

    Maintain master documentation, version control, and inspection readiness.

    Manage offline stakeholder reviews and incorporate feedback efficiently.

    Lead global translation management for documentation and enablement materials.

    Enablement, Change & Solution Partnership

    Act as a key contributor and process authority to Content Enablement led initiatives, including MLR AI.

    Provide subject-matter expertise on process design, compliance controls, BAU integration, etc

    Ensure new solutions are embedded into standard MLR operations (ie Tier Based Review).

    Partner with change management resources to drive sustained adoption of global standards.

    BAU Governance, Stakeholder Enablement & Support

    Lead ongoing MLR BAU governance including PromoMats CAB participation, Agile stand-ups, and MAP sessions.

    Act as senior escalation point for process-related queries from key user groups.

    Act as Global PromoMats Affiliate Lead for above country

    Oversee inactive user monitoring, ownership reassignment, and Affiliate follow-up.

    Issue proactive communications reinforcing governance, process updates, and value-driven behaviours.

    Numbers & Facts

    LocationNorthbrook, IL
    IndustryBiotechnology/Pharmaceuticals
    Company Size2,500 to 4,999 employees
    Websitehttps://www.astellas.com/us/
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    Skills

    • Agile Programming Methodologiesunmatched
    • Artificial Intelligence (AI)unmatched
    • Biologyunmatched
    • Change Managementunmatched
    • Change Requests/Ordersunmatched
    • Communication Skillsunmatched
    • Content Developmentunmatched
    • Corrective Actionunmatched
    • Delivery Drivingunmatched
    • Diseaseunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • Embedded Systemsunmatched
    • Establish Prioritiesunmatched
    • Healthcareunmatched
    • Immunologyunmatched
    • Oncologyunmatched
    • Ophthalmologyunmatched
    • Process Improvementunmatched
    • Research & Development (R&D)unmatched
    • Riskunmatched
    • Risk Managementunmatched
    • Source Code/Configuration Management (SCM)unmatched
    • Standard Operating Procedures (SOP)unmatched
    • Standup Meetingsunmatched
    • Technical Operationsunmatched
    • Urologyunmatched
    • User Groupsunmatched
    • Women's Healthunmatched

    About Company

    Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.

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