Remote Nonclinical Writer for Regulatory Submissions

MMS; Baltimore (MD); Remote; USD 78,720 - 108,240; Full time

Job summary

A leading clinical research organization is seeking a technical writer to develop and manage nonclinical documents. This full-time remote position requires a BS in pharmacology or related fields, with a minimum of 2 years in regulatory writing. Candidates should possess strong analytical skills and familiarity with regulatory guidelines. Join an innovative team shaping the future of clinical research.

Qualifications

• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsibilities

• Lead the writing of nonclinical documents and ensure alignment with regulatory guidelines.
• Collaborate with cross-functional teams on complex projects.
• Interpret and analyze pharmacokinetics, pharmacology, and toxicology data.

Skills

Strong writing and analytical skills

Organizational expert within the nonclinical subject area

Excellent written/oral communication

Ability to work in various client systems

Negotiation and collaboration skills

Education

BS + in pharmacology, toxicology, biology or chemistry

Tools

MS Office applications

Job description

A leading clinical research organization is seeking a technical writer to develop and manage nonclinical documents. This full-time remote position requires a BS in pharmacology or related fields, with a minimum of 2 years in regulatory writing. Candidates should possess strong analytical skills and familiarity with regulatory guidelines. Join an innovative team shaping the future of clinical research.