Remote Nonclinical Writer for Regulatory Submissions

MMS; Philadelphia (Philadelphia County); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading clinical research organization is seeking a Nonclinical Writer to develop and manage technical documents in a supportive and innovative environment. The role requires strong writing skills and at least 2 years of regulatory writing experience. Applicants should have a BS+ in pharmacology or a related field. This full-time role offers remote work flexibility and the chance to collaborate with a diverse team on complex regulatory submissions.

Qualifications

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

Responsibilities

• Lead projects independently with minimal oversight.
• Author highly technical nonclinical documents.
• Collaborate with cross-functional teams.

Skills

Strong writing and analytical skills

Excellent written/oral communication

Organizational expertise

Ability to collaborate with teams

Education

BS+ in pharmacology, toxicology, biology or chemistry

Tools

MS Office applications

SharePoint

Veeva RIM

Job description

A leading clinical research organization is seeking a Nonclinical Writer to develop and manage technical documents in a supportive and innovative environment. The role requires strong writing skills and at least 2 years of regulatory writing experience. Applicants should have a BS+ in pharmacology or a related field. This full-time role offers remote work flexibility and the chance to collaborate with a diverse team on complex regulatory submissions.