Katalyst Healthcares & Life Sciences
Senior medical writer Job at Katalyst Healthcares & Life Sciences in Pleasanton
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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