
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.