Regulatory Affairs Associate I

Regulatory Affairs Associate I#26-11111

$33.03-$35.16 per hour

Irvine, CA

All On-site

Job Description

Job Description:

Contributions will include: 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.

Responsibilities:

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.

Qualifications:

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.

Possess strong interpersonal and communication skills, with the ability to productively communicate with disparate personnel and departments.