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Scientific Writer Regulatory Affairs Associate

The Fountain Groups, Irvine, CA, United States


100% ONSITE IRVINE CA

Pay: $35-$38/hr


REQUIRED:

  • Bachelor's degree in life sciences, clinical lab science or equivalent. Masters preferred.
  • 3+ years of regulatory writing experience.
  • Exhibits flexibility and a commitment to scientific excellence.
  • Posses strong interpersonal and communication skills, with the ability to productively communicate with disparate personnel and departments
  • Ability to generate graphs and figures for journal publications and poster presentations; manage secure documentation systems such as One Vault, SharePoint, and ARCH/COSMOS; successful preparation of high-quality submission and presentation-ready documents; ensure project information in publication records and resourcing tools are accurate and up-to-date.

Job Descirption:

  • Oversee controlled documents and processes: internal study reports and nonclinical modules of regulatory submissions.
  • Oversee non-controlled documents: preparation of publication projects, journal manuscripts, abstracts, and posters.
  • Manage documentation systems
  • Complete miscellaneous scientific writing projects as needed.