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【R&D】Regulatory Compliance Group, Regulartory Division (Staff)

Местоположение Kita-ku, Ōsaka-fu, Япония Идентификатор вакансии R-100954 Дата публикации 02/25/2021

Description:

  • ANGEL Business Specialist is responsible for
    • Leading and supporting ANGEL related activities, and providing administrative & process support to ensure compliant usage of the system by the Japan ANGEL users
    • Leading eCTD submission activities to achieve efficient submissions while ensuring quality and compliance

Responsibilities:

ANGEL Business Specialist has the following responsibilities to ensure compliance with the ANGEL and Regulatory requirements as well as to ensure eCTD submissions are managed in line with the agreed standards and timelines (ensure that the following points are managed if these responsibilities are delegated to the EHRs).

ANGEL

  • Manage user access to ANGEL Document Management (DM) and Tracking
    • Manage the Japan user accounts and User List
    • Manage local business groups
  • Manage documents in ANGEL DM
    • Manage the local ANGEL Document Naming Conventions
    • Conduct document publishing/approval according to the agreed standards and timelines
  • Manage regulatory submission information in ANGEL Tracking (Register)
    • Enter and manage regulatory submission information in Register
  • Provide ANGEL training to the users
    • Develop and maintain ANGEL training materials
    • Deliver ANGEL classroom training/awareness sessions to the users
  • Provide business/process support to Japan ANGEL users
    • Respond to requests and questions as appropriate
    • Escalate issues to the Japan ANGEL Business Lead and/or the relevant Global ANGEL teams and work together until the issues are resolved
  • Lead/Support ANGEL projects
    • Lead/Support ANGEL projects working closely with the stakeholders
    • Lead/Support ANGEL related activities (e.g. performance tests, introduction of new processes) collaborating with the relevant AZKK and/or Global functions
    • Develop and maintain the local ANGEL procedural documents

eCTD

  • Lead eCTD related activities
    • Ensure that CTD authors understand the eCTD processes
    • Ensure that eCTD activities meet the agreed timelines
    • Ensure continuous improvement of the eCTD processes

  • Manage eCTD vendor activities
    • Ensure necessary contracts and service level agreements are in place
    • Work with the eCTD vendor to achieve continuous improvement of the eCTD processes

General

  • Ensure that own work is performed in accordance with appropriate SHE and Compliance standards
  • Proactively participate in continuous improvement activities as appropriate

Requirements:

Education

  • Undergraduate degree required

Required Experience

  • Experience in project support role
  • Basic knowledge of information management and document management
  • Good written and verbal communication skills (Japanese and English)
  • Strong organizational, operational & customer service skills
  • Strong working knowledge of information technology & desktop applications

Preferred Experience

  • Understanding of AZ Drug Development process and Product Life Cycle Management
  • Knowledge of ANGEL systems and other AZ tools, processes and standards
  • Experience in Regulatory Affairs, Clinical or R&D Drug Development
  • Experience in working in a team-based organization
  • English speaking level 6 or above

Skills and Capabilities

  • Good written and verbal communication skills (English speaking level 6 or above)
  • Leadership Capabilities with a focus on the following capabilities
    • Commitment to Customers & Integrity
    • Strategic Leadership
    • Works Collaboratively
  • Focus on Delivery and results orientation
  • Communication skill
    • Communicate properly and effectively what needs to be communicated, and understand correctly what others say
  • Interview skill
    • Properly obtain accurate and necessary information in a prompt manner
  • Logical thinking
    • Review and structuralize tacit knowledge to lead to a clear conclusion
  • Writing skill
    • Logically present clearly structured thoughts, ideas, comments using words, graphics, etc. as required
  • Presentation skill
    • Express necessary knowledge or intention to audience effectively
  • Meeting management
    • Achieve meeting objectives effectively by successful preparation or chairing
  • Facilitation skill
    • Create an innovative solution in a conflicting discussion by appropriate intervention.
  • Project management
    • Knowledge, know-how and skill set to complete a project to meet client needs, at agreed timing and cost

Feeder roles:

  • The person who has experience in system management
  • The person who meets the requirements above

Measures of Success:

  • No major compliance issues on the use of ANGEL
  • No major complaints on ANGEL administration and processes from users
  • No major negative impact on eCTD submissions

Reporting Relationship:

  • Report to: Regulatory Compliance Group Manager
  • Direct reports: None


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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