Remote Nonclinical Writer - Regulatory Submissions Lead

MMS; Toledo (OH); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading clinical research organization is seeking a Nonclinical Writer to develop and write regulatory documents. The role involves collaborating with cross-functional teams and ensuring compliance with regulatory guidelines. Ideal candidates must have a BS+ in a related field and 2+ years of nonclinical writing experience. Strong writing skills and familiarity with GLP and ICH guidelines are essential for this remote position.

Qualifications

• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Basic understanding of CROs and scientific & nonclinical data/terminology.

Responsibilities

• Lead projects independently with minimal oversight.
• Collaborate with cross-functional teams.
• Complete documents according to sponsor’s format and guidelines.

Skills

Strong writing and analytical skills

Knowledge of GLP, ICH guidelines

Proficiency with MS Office applications

Education

BS+ in pharmacology, toxicology, biology or chemistry

Tools

SharePoint

Veeva RIM

EndNote

Job description

A leading clinical research organization is seeking a Nonclinical Writer to develop and write regulatory documents. The role involves collaborating with cross-functional teams and ensuring compliance with regulatory guidelines. Ideal candidates must have a BS+ in a related field and 2+ years of nonclinical writing experience. Strong writing skills and familiarity with GLP and ICH guidelines are essential for this remote position.