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Claire Wright

Claire wright

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location of Claire WrightGreater Melbourne Area
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  • Timeline

  • About me

    Associate Director, Alliance Management at CSL

  • Education

    • Swinburne university of technology

      2009 - 2010
      Diploma frontline management

      Modules: Manage People Performance, Ensure Team Effectiveness, Facilitate Continuous Improvement, Manage Operational Plan, Manage Budgets and Financial Plans, Manage Quality Customer Service, Manage Projects, Develop a Workplace Learning Environment.

    • The university of sheffield

      2000 - 2004
      Phd genomic medicine

      Laboratory based research project to establish the role of Neisseria meningitidis proteins in the pathogenesis of bacterial meningitis.Laboratory techniques: Bacterial cell culture, PCR, DNA sequencing, gene cloning, recombinant protein expression and purification, SDS-PAGE, western blotting, ion exchange and affinity chromatography, yeast two-hybrid system to detect protein-protein interactions.

    • The university of sheffield

      1997 - 2000
      Bsc (hons) genetics

      Activities and Societies: President of the Molecular Biology and Biotechnology Society. Organised Biological Sciences Ball for 500 undergraduate students.

  • Experience

    • Asterion ltd

      Jan 2003 - Apr 2005
      Postdoctoral researcher

      Researched and developed novel antagonistic molecules to potentially treat human growth disorders.

    • Future science group

      Apr 2005 - Aug 2006

      Established a database to manage all stages of the commissioning, review and publishing process.Commissioned a multidisciplinary study which received international coverage in over 30 publications including the New York Times, Sydney Morning Herald, Science and Nature.Prepared in-house genetics style guide.Responsible for line management of commissioning editors. Fully responsible for content acquisition and quality.Researched and prepared monthly news updates.Helped to establish PGBase, a comprehensive pharmacogenomics database.

      • Senior Editor, Pharmacogenomics and Personalised Medicine

        Feb 2006 - Aug 2006

      • Commissioning Editor, Pharmacogenomics and Personalised Medicine

        Apr 2005 - Feb 2006

    • Csl

      Apr 2007 - now

      Prepared global regulatory submissions to support licensure of recombinant coagulation products.Collaborated with colleagues in the US, Europe and Japan.Designed databases to enable the compilation and analysis of agency feedback on global marketing submissions to enhance the development of future products.Provided regulatory support and advice to early clinical development programmes to facilitate the development of novel breakthrough therapies.Conducted regulatory intelligence to identify new regulations, guidelines and agency feedback on competitor products. Show less Co-ordination and preparation of R&D regulatory project plans, pathways and processes. Prepared Regulatory Position PapersProvided support for compilation and review of regulatory submissions.Provided support for cross functional team planning.Assisted in the transfer of Regulatory Affairs activities to colleagues in the USA.Monitored and reported milestones and project progress.Developed project planning and monitoring tools.Organised team building offsite for Regulatory Affairs department. Show less

      • Associate Director of Alliance Management

        Jun 2024 - now

      • Senior Manager Alliance Management

        May 2020 - Jun 2024

      • Senior Manager, Portfolio Planning & Partnerships

        Feb 2017 - May 2020

      • CMC Manager, Global Regulatory Affairs (Development Products)

        May 2015 - Feb 2017

      • Regulatory Affairs Associate - CMC Specialist, Recombinant Protein Product Development

        Apr 2013 - May 2015

      • Projects Associate, Regulatory Affairs Liaison and Co-ordination

        Dec 2008 - Apr 2013

      • Regulatory Affairs Officer, Biotechnology

        Apr 2007 - Dec 2008

  • Licenses & Certifications