Senior Nonclinical Writer (US)

Location: Remote, based in the United States; Canton, Michigan

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical research and regulatory submission services.

What you will do

• Develop, write, and manage technical nonclinical documents, including Module 2.4 and 2.6 eCTD documents, Investigator’s Brochures, Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
• Lead nonclinical writing projects for IND, CTA, NDA, BLA, and MAA submissions with minimal oversight.
• Build mapping plans for placing nonclinical studies within eCTD Module 2.4 and 2.6 structures.
• Interpret pharmacokinetic, pharmacology, and toxicology data from study reports and supporting technical sources.
• Coordinate with project management, safety, efficacy, biostatistics, regulatory operations, and CMC teams.
• Lead client meetings and complex projects while ensuring documents meet sponsor formats and regulatory guidelines.

Requirements

• 5+ years of pharmaceutical regulatory nonclinical writing experience.
• Bachelor’s degree or higher in pharmacology, toxicology, biology, chemistry, or a related field, with relevant industry experience.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• Strong scientific writing, analytical, communication, time-management, and project-management skills.
• Proficiency with Microsoft Office and ability to work with SharePoint, Veeva RIM, PleaseReview, EndNote, and client templates.
• Understanding of CROs, scientific and nonclinical data, and the drug development process.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.

Culture & Benefits

• Full-time remote work.
• Collaborative and inclusive work environment.
• Opportunity to support pharmaceutical, biotech, and medical device development across a global CRO.
• Great Place to Work certified organization with a focus on employee retention and supportive teamwork.