Senior Nonclinical Writer

TL;DR

Senior Nonclinical Writer: Development, writing, and management of highly technical nonclinical documents including Module 2.4 and 2.6 eCTD submissions, Investigator’s Brochure, and Nonclinical Study Reports with an accent on regulatory compliance, scientific integrity, and alignment with guidelines. Focus on interpreting complex pharmacokinetics, pharmacology, and toxicology data from GLP/non-GLP studies, leading projects independently, and developing mapping plans for eCTD structures.

Location: Remote position for candidates based out of the UK

Company

Award-winning, data-focused clinical research organization (CRO) supporting pharmaceutical, biotech, and medical device industries with a global footprint across four continents.

What you will do

• Develop and write nonclinical documents such as Module 2.4/2.6 eCTD submissions, Investigator’s Brochure, Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
• Lead projects independently, structure content and messaging, ensure alignment with regulatory guidelines and scientific integrity.
• Author from technical sources including GLP/non-GLP study reports, in vivo/in vitro data, Prism files, bioanalytical, clinical pathology, and PK/TK reports.
• Develop mapping plans for nonclinical studies in eCTD structures and interpret PK, pharmacology, toxicology data.
• Collaborate with cross-functional teams (project management, safety, biostats, regulatory, CMC) and lead client meetings/CRMs.
• Work in client systems (SharePoint, Veeva RIM, PleaseReview, EndNote) following sponsor formats and regulatory guidelines.

Requirements

• BS+ in pharmacology, toxicology, biology, chemistry or related field 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, GCP, GMP, GDP)
• Strong writing, analytical, communication, time/project management skills
• Proficiency with MS Office; hands-on experience with client systems and tools
• Basic understanding of CROs, scientific/nonclinical data, terminology, and drug development process

Culture & Benefits

• Great Place to Work certified with exceptional culture and industry-leading employee retention.
• Supportive, innovative, collaborative, and inclusive work environment.
• Global team fostering professional growth and high customer satisfaction.