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Astellas Pharma Associate Director Standard & Excellence in United States

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing an Associate Medical Affairs Standards & Excellence Director opportunity. This position can be based in Northbrook, Illinois; Chertsey, England or Leiden, Netherlands.

Purpose & Scope:

Leads execution, implementation, adherence to and innovation of internal processes related to Medical Affairs (MA) standards globally, including MA External funding for Research and Education (e.g. Investigator Sponsored Research (ISR), Grants for Education and Sponsorships and MA Activities (e.g. Scientific Exchange, Symposia, Collaborative Research, MSL excellence). Provides thought leadership and subject matter expertise, bringing environmental insights to Astellas MA standards to impact MA performance in these functional areas across Astellas regions and functions.

Essential Job Responsibilities:

  • Provides subject matter expertise and consultation to Medical Affairs regions regarding processes for MA Standards including MA external funding for Research/Education (e.g. ISRs, Sponsorships, Grants for Education), Symposia, Collaborative Research, Scientific Exchange and MSL Excellence
  • Coordinates and works closely with Medical Affairs leaders (e.g. regional MA SMEs, Medical Information, publications) and involved with Medical Affairs MA external funding activities (Sponsorships, and Grants for Research and Education), Symposia, Collaborative Research, Scientific Exchange, Advisory Boards, non-promotional MA materials review and MSL Excellence including regional, and representatives from non-MA departments (e.g. Ethics & Compliance and Legal).
  • Attends relevant Industry meetings to stay abreast with current best practices and new developments in all relevant MA activities.
  • Actively monitors external developments in MA Standards and incorporates industry best practices into Astellas' processes for these areas.
  • Represents Astellas at global forums, conferences, and professional associations on MA Standards and Excellence; helps shape future industry best practices.
  • Owns the global process for MA standards (including Grants and other external funding activities), supporting the Sr. Director, MA Standards & Excellence on implementation:

  • Addresses key region and global stakeholder issues related to implemented global processes.

  • Identifies opportunities to improve core processes in MA Standards based on qualitative feedback and metrics analysis.
  • Serves as business lead for process improvement initiatives related to domain area.
  • Develops and, monitors on key performance metrics related to MA Standards in partnership with Data Repositories and Metrics & Analytics.
  • Monitors compliance to processes and supports data governance standards set by Metrics & Analytics. Ensures local and regional adherence to global processes by working closely with Process Improvement and QA functions.
  • Works with key region MA stakeholders to address gaps in data governance that are identified by Metrics & Reporting team and MA Data Repositories team.

Quantitative Dimensions:

  • Global process owner for 3-4 global processes in Medical Affairs.
  • Management of at least 5-6 MA activities under annual process review with Process Optimization.
  • Proactive application of risk mitigation strategies that minimize corporate risk in partnership with Process Optimization.
  • Matrix Management of MA colleagues within regions (Americas, Asia Oceania, EMEA, and Japan) in creating global processes for MA activities.

Organizational Context:

  • Reports to Sr. Director, MA Standards & Excellence
  • Works closely with MA colleagues, CMT members, Region MA SME leaders in regions (Director Level) and MA leaders (Senior Director Level).
  • Collaborates with Medical Affairs colleagues across geographies.
  • Partners within MA Operational Excellence (Data Repositories, Metrics & Analytics, Process Optimization, Study & ISR Operations, and Project Management).

Qualifications:

Required

  • Advanced Degree in a scientific discipline, with preference for life science PhD and MDs.
  • Minimum of 10 years' experience in healthcare industry.
  • Minimum of 5 years' experience with MA External funding (including ISR, Grants for Education, Sponsorships) and/or MA Activities (Symposia, Collaborative Research, Scientific Exchange and/or MSL Excellence ) in a MA organization.
  • Demonstrated collaboration in a matrix organization.
  • Demonstrated ability to manage multiple projects and competing priorities.
  • Fluent in written and verbal business English.
  • Effective management skills, including the ability to effectively engage within cross-functional teams.
  • High level understanding of project management, quality assurance and data repository best practices.
  • Strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict-resolution skills, organization and planning skills.

Preferred

  • Advanced degree in the clinical sciences, with preference for Doctoral level degrees.
  • Work experience across multiple cultures and countries / regions is a plus.

*LI-CH1

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Medical Affairs

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