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