Scientific Writer – Regulatory Affairs
Collabera, Irvine, CA, United States
Job Summary
The Regulatory Affairs Associate I will support scientific writing and regulatory documentation activities within a fast-paced research environment. This role focuses on developing high-quality regulatory and publication materials, managing documentation systems, and ensuring accuracy across submission records. The ideal candidate will have strong writing skills and experience working with regulatory documents and scientific data.
Key Responsibilities
Develop graphs and figures for journal publications and scientific presentations
Prepare high-quality regulatory documents, manuscripts, abstracts, and posters
Manage and maintain documentation systems including One Vault, SharePoint, and ARCH or COSMOS
Ensure accuracy and completeness of publication records and resourcing tools
Oversee controlled documents such as internal study reports and nonclinical regulatory modules
Support preparation of non-controlled documents for publication and research activities
Collaborate cross-functionally to support scientific writing and documentation needs
Complete additional scientific writing projects as assigned
Required Qualifications
Bachelor’s degree in life sciences, clinical laboratory science, or a related field
Minimum of 3 years of regulatory writing experience
Strong scientific writing and documentation skills
Experience managing document management systems and tools
Excellent communication and interpersonal skills
Ability to work collaboratively across multiple teams
Preferred Qualifications
Master’s degree in a relevant scientific discipline
Experience supporting regulatory submissions and publication processes
Familiarity with scientific data visualization and presentation development
Benefits The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking or public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.
Pay Range $30/hr to $35/hr
#J-18808-Ljbffr
Key Responsibilities
Develop graphs and figures for journal publications and scientific presentations
Prepare high-quality regulatory documents, manuscripts, abstracts, and posters
Manage and maintain documentation systems including One Vault, SharePoint, and ARCH or COSMOS
Ensure accuracy and completeness of publication records and resourcing tools
Oversee controlled documents such as internal study reports and nonclinical regulatory modules
Support preparation of non-controlled documents for publication and research activities
Collaborate cross-functionally to support scientific writing and documentation needs
Complete additional scientific writing projects as assigned
Required Qualifications
Bachelor’s degree in life sciences, clinical laboratory science, or a related field
Minimum of 3 years of regulatory writing experience
Strong scientific writing and documentation skills
Experience managing document management systems and tools
Excellent communication and interpersonal skills
Ability to work collaboratively across multiple teams
Preferred Qualifications
Master’s degree in a relevant scientific discipline
Experience supporting regulatory submissions and publication processes
Familiarity with scientific data visualization and presentation development
Benefits The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking or public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.
Pay Range $30/hr to $35/hr
#J-18808-Ljbffr