Nonclinical Writer

TL;DR

Nonclinical Writer: Develop, write, and manage highly technical nonclinical documents including Module 2.4/2.6 eCTD submissions, Investigator’s Brochure, and study reports with an accent on regulatory compliance, scientific integrity, and data mapping. Focus on analyzing pharmacokinetics, pharmacology, and toxicology data, leading projects independently, and collaborating with cross-functional teams.

Location: Remote (full-time)

Company

Award-winning CRO supporting pharmaceutical, biotech, and medical device industries with data-focused solutions for clinical trials and regulatory submissions, with global presence across four continents.

What you will do

• Develop and write nonclinical documents like Module 2.4/2.6 eCTD, IB, study reports, meeting requests, and briefing documents.
• Lead projects independently, structure content, ensure alignment with regulatory guidelines and scientific standards.
• Author from technical sources including GLP/non-GLP study reports and in vivo/in vitro data.
• Create mapping plans for nonclinical studies in eCTD structures.
• Interpret PK, pharmacology, and toxicology data from various reports.
• Collaborate with project management, safety, biostats, regulatory, and CMC teams; lead meetings and manage client relationships.

Requirements

• BS+ in pharmacology, toxicology, biology, chemistry or related, with industry experience in regulatory writing, affairs, lab sciences, or QA/QC.
• 2+ years pharmaceutical regulatory nonclinical writing experience.
• Knowledge of GLP, ICH guidelines, and regulatory requirements (FDA, EMA).
• Strong writing, analytical, communication, time/project management skills.
• Proficiency in MS Office; experience with SharePoint, Veeva RIM, PleaseReview, EndNote.
• Hands-on experience with clinical trials and drug development preferred; understanding of CROs and nonclinical data.

Culture & Benefits

• Supportive, innovative team environment certified as Great Place to Work.
• Industry-leading employee retention and customer satisfaction.
• Collaborative and inclusive culture fostering career growth.