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Job Details


Associate Manager, Material Approval Process (MAP)

Pharmaceuticals

All

Yearly

No

Northbrook, Illinois, United States

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View] .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

This position manages portions of the MAP (Material Approval Process) for commercial marketing materials, initiatives, projects, and processes. The individual promotes a high sense of collaboration with both internal and external partners, across multiple functional areas of responsibility. Key responsibilities include ensuring all promotional development and approval related processes are completed accurately, in a timely manner, and in compliance with Regulatory and Legal standards in MAP. This position must be able to lead change and lead project development and implementation for continual process improvements, perform as project manager for larger cross functional initiatives.

Essential Job Responsibilities:

  • Be able to assist the MAP Manager/MAP Director to lead and manage the promotional Material Approval Process (MAP), from early-stage project development through review, production, and final distribution. Including document flow, workload volumes, process performance management and issue resolution related to MAP.
  • Execute Astellas high performance and ethical expectations consistently while promoting a high sense of collaboration.
  • Ensure all promotional development and approval related processes are completed accurately, in a timely manner, in compliance with regulatory/legal standards.
  • Lead and ensure a clear and concise MAP and Veeva Training/Onboarding process is established, and implemented for ongoing training
  • Partner proactively with management in MAP, Commercial, Medical, Regulatory, Compliance, IT to explore/identify issues or opportunities relevant to: process efficiencies, review team dynamics, etc.
  • Act as liaison for Marketing Operations to ensure MAP and team are in alignment with commercial strategies and positioned as strategic partner; in collaboration with but not limited to: marketing teams, Sales Training, Health Systems, Reimbursement, IT, outside vendors and internal review teams.
  • This position has a responsibility to provide insight to developments or changes in industry and how to best stay current or be market leaders in process and technologies.
  • Monitor/maintain controlled documents to keep current and valid. When appropriate, modify as needed when change in market conditions, internal business process, or FDA guidance necessitate enhancement of departmental control documents.
  • Act as facilitator in project negotiations, summarize team agreements and facilitate progress of projects.
  • This position may provide oversight of contract personnel in a variety of support roles.

Quantitative Dimensions:

  • Manage Veeva Vault vendor to achieve effective system support of MAP operations.

Organizational Context:

  • Reports to MAP Manager
  • This position requires close collaboration with domestic colleagues in R&D, Business Analytics, Regulatory, and Legal, Manufacturing as well as the Marketing and Sales commercial teams. Global development compounds will also require collaboration with Astellas Pharma, Inc (Japan) and APEL (Europe).