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Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences is hiring: Senior medical writer in Pleasan

Katalyst Healthcares & Life Sciences, Pleasanton, CA, United States, 94566


Job Description

Primary Skills:

  • Medical Writing Experience with focus on Clinical Validation Plan, protocols, Clinical Study reports, Manuscripts and other regulatory/medico-marketing documents in In-vitro Devices (IVD)/Genetics and Oncology domain and project management experience
  • Clinical Research
  • Good Clinical Practice
  • Good spoken and written English
  • Experience in working with Templates, Style Guides, SharePoint and Document Management Tools
  • Understanding of Regulatory Requirements for IVDs
  • Understanding of Audit Requirements for IVDs

Requirements:

  • Relevant experience in medical writing/information domain: 8-10 years with focus on Clinical Validation Plan, protocols, Clinical Study reports, Manuscripts and other regulatory/medico-marketing documents and project management experience
  • Special Skills & Knowledge

Education:

  • Bachelor’s degree in Medicine /PhD in Life sciences
  • Master’s degree in Bio-Medical Sciences or related fields with 8-10 years research and/or medical writing/publication experience
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