Remote Nonclinical Writer for Regulatory Submissions

MMS; Chicago (IL); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading clinical research organization is seeking a Nonclinical Writer to develop and manage highly technical nonclinical documents. This remote, full-time role involves close collaboration with various teams and requires strong writing skills, regulatory knowledge, and the ability to navigate complex scientific data. Candidates should hold a relevant degree and have 2+ years of experience in pharmaceutical regulatory writing.

Qualifications

• 2+ years of pharmaceutical regulatory nonclinical writing experience required.
• Knowledge of GLP, ICH guidelines, and regulatory requirements is essential.
• Hands-on experience with clinical trials preferred.

Responsibilities

• Develop and write nonclinical documents for regulatory submission.
• Lead projects with minimal oversight.
• Collaborate with cross-functional teams.

Skills

Strong writing and analytical skills

Excellent written/oral communication

Project management skills

Ability to operate in various client systems

Education

BS + in pharmacology, toxicology, biology or chemistry

Tools

MS Office

SharePoint

Veeva RIM

Job description

A leading clinical research organization is seeking a Nonclinical Writer to develop and manage highly technical nonclinical documents. This remote, full-time role involves close collaboration with various teams and requires strong writing skills, regulatory knowledge, and the ability to navigate complex scientific data. Candidates should hold a relevant degree and have 2+ years of experience in pharmaceutical regulatory writing.