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Clinical Medical Writer/Research Associate

Organization
Agilent
Job Location
6392 Via Real, Carpinteria
Carpinteria, CA 93013
United States
Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

We are looking for a Clinical Medical Writer/Research Associate to join our Clinical Affairs team. In this role the primary responsibility is to compile clinical performance data for all CE marked products for reporting purposes in compliance with IVDR (EU) 2017/746. These activities will be conducted in collaboration with Research & Development, Quality Assurance, Regulatory Affairs, and other partners. Additional responsibilities will include the planning, coordinating and management of the day-to-day running of clinical studies to support regulatory applications and scientific marketing activities.

Responsibilities include the following:

  • Assist in developing Clinical Performance Plans for products planned for CE marking
  • Research internal controlled documents and IFU for existing clinical performance data
  • Conduct literature searches
  • Collaborate with other internal partners to build and compile the required documents per EU regulation (IVDR)
  • Write Clinical Performance Reports for existing and newly developed products/product bundles
  • Contribute to the development of Clinical processes associated with IVDR compliance
  • Assist with submitting compiled data to FDA or other regulatory agencies as appropriate
  • Guide projects in conformance with requirements
  • Identify, evaluate and qualify clinical study sites
  • Conduct monitoring at clinical sites including SIVs, IMV, and COVs
  • Assist with site contracting and vendor/CRO management
  • Maintain study files
  • Assist in the distribution of trial-related information to relevant persons/bodies
  • Coordinate EC/IRB approvals

 This role is at our Santa Clara or Carpinteria sites in CA- currently remote due to COVID

Requirements

Qualifications

  • Bachelors or Master's or University Degree or equivalent in Biology, Biotechnology, or similar (knowledge of immunohistochemistry is ideal)
  • 2+ years of proven experience
  • Experience in technical/science/medical writing
  • Proficiency in MS applications (Word, excel, outlook) 

 

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