Sharon Versteeg

Experience

• 

  Vivian Corporation

  Sept 2001 - Sept 2003

  Managing Pharmacist

  This position involved day to day running of the pharmacy, including supply of medicinal products, giving advice to patients and supervision of the sales team.

• 

  Actavis

  Mar 2003 - Feb 2004

  Medical Representative

  Responsible for the marketing of new products within Actavis and contact with specialists on this regard. Regular visits to specialists and presentations during conferences was an essential part of the job.

• 

  Universiteit Utrecht

  Apr 2006 - Jun 2010

  PhD Student

  Research in the separation of peptides and proteins using liquid chromatography and mass spectrometry. The research has been completed in one of the largest laboratories in Europe led by Professor Albert Heck.

• 

  Astellas Pharma Europe

  Jul 2010 - Apr 2016

  Clinical Trial Material (CTM) manager

  Responsible for the provision and management of CTM supplies in phase I-III studies. This role required a close collaboration with the clinical teams, drug development teams, quality group and clinical manufacturing organizations for the packaging, labeling and distribution of supplies.Responsibilities within this role included: -• Provision of CTM for clinical studies in accordance with study timelines, Astellas SOPs, Good Manufacturing Practice (GMP) guidelines, ICH GCP guidelines, GDP and applicable laws/regulations.• Setting up and managing the packaging, labeling, distribution and IRT budget for the studies.• Setting up the Interactive response technology (IRT) for the study.• Manage Vendors (CMO) mainly responsible for packaging, distribution and possibly QP release. • Training of clinical sites and investigators on the handling of the medication as well as IRT.• Managing the distribution chain and shipments as well as temperature excursions at site and depot.• Provide CTM documents for submission purposes and handle any questions from the authorities related to CTM.• Provide project plans and prepare forecasts for the supplies.• Act as a bulk coordinator for the ordering of medication for several phase III studies. عرض أقل

• 

  Astellas Pharma

  Apr 2016 - Dec 2021

  Senior Clinical Supplies Manager

  Promoted to senior manager to manage mainly phase III-IV complex studies, setting up strategic partnership with vendors, leading global teams and working with Japan and US to harmonize specific clinical supply chain processes and documents within the company.Responsibilities within this role include: -- Established a global harmonized (US, Japan) electronic label generation process with a labeling partner.- Managing complex global studies ensuring continuous clinical supplies, including the provision of multiple comparators.- Leading a taskforce to set a global packaging and labeling document for Astellas.- Providing input within a global team on master service agreements and quality agreements from a clinical supplies perspective to ensure it covers Astellas requirements - leading to the finalization of a global MSA.- Represented the Clinical supplies team within a global Interactive Response Technology (IRT) taskforce which led to the establishment of global IRT standards.- Setting up global KPIs and managing global meetings for vendor management. عرض أقل

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  Astellas Europe

  Dec 2021 - now

  • Director EU CSC team lead

    Apr 2022 - now

  • EU Team Lead Associate Director Clinical supplies Astellas Pharma Europe

    Dec 2021 - May 2022