Scientific Writer
2 - 5 years
Irvine, CA
Contract
Onsite
1 month ago
About the role
Job Summary:
The company is seeking a detail-oriented Regulatory Affairs Associate to support scientific writing, regulatory documentation, and publication activities within a fast-paced research and development environment. This role will focus on preparing submission-ready documents, managing publication materials, and maintaining documentation systems to support regulatory and scientific communication initiatives.
Key Responsibilities:
• Prepare graphs, figures, and scientific content for journal publications, abstracts, posters, and presentations
• Support the preparation and review of regulatory submission documents and nonclinical modules
• Manage controlled and non-controlled documentation within electronic documentation systems
• Maintain accurate project information within publication records and resource tracking tools
• Coordinate scientific writing activities and ensure documentation quality and compliance standards
• Collaborate cross-functionally with research, clinical, and regulatory teams to support publication projects
• Assist with miscellaneous scientific writing and documentation initiatives as needed
Required Qualifications:
• Bachelor’s degree in Life Sciences, Clinical Laboratory Science, or related scientific discipline
• Minimum 3 years of regulatory writing or scientific writing experience
• Experience preparing journal manuscripts, abstracts, posters, and regulatory documentation
• Proficiency with documentation management systems such as SharePoint, Vault, or similar platforms
• Strong written and verbal communication skills
• Excellent organizational skills with strong attention to detail
• Ability to work collaboratively in a cross-functional environment
Preferred Qualifications:
• Master’s degree in a scientific discipline
• Experience supporting publication planning and regulatory submissions within the pharmaceutical or biotechnology industry
• Familiarity with scientific publication processes and documentation compliance standards
• Strong interpersonal skills and ability to manage multiple priorities effectively
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/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
The company is seeking a detail-oriented Regulatory Affairs Associate to support scientific writing, regulatory documentation, and publication activities within a fast-paced research and development environment. This role will focus on preparing submission-ready documents, managing publication materials, and maintaining documentation systems to support regulatory and scientific communication initiatives.
Key Responsibilities:
• Prepare graphs, figures, and scientific content for journal publications, abstracts, posters, and presentations
• Support the preparation and review of regulatory submission documents and nonclinical modules
• Manage controlled and non-controlled documentation within electronic documentation systems
• Maintain accurate project information within publication records and resource tracking tools
• Coordinate scientific writing activities and ensure documentation quality and compliance standards
• Collaborate cross-functionally with research, clinical, and regulatory teams to support publication projects
• Assist with miscellaneous scientific writing and documentation initiatives as needed
Required Qualifications:
• Bachelor’s degree in Life Sciences, Clinical Laboratory Science, or related scientific discipline
• Minimum 3 years of regulatory writing or scientific writing experience
• Experience preparing journal manuscripts, abstracts, posters, and regulatory documentation
• Proficiency with documentation management systems such as SharePoint, Vault, or similar platforms
• Strong written and verbal communication skills
• Excellent organizational skills with strong attention to detail
• Ability to work collaboratively in a cross-functional environment
Preferred Qualifications:
• Master’s degree in a scientific discipline
• Experience supporting publication planning and regulatory submissions within the pharmaceutical or biotechnology industry
• Familiarity with scientific publication processes and documentation compliance standards
• Strong interpersonal skills and ability to manage multiple priorities effectively
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/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