Senior Nonclinical Writer (Pharmaceutical Regulatory Writing)

Location: Remote, candidates must be based in the United Kingdom

Company

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

What you will do

• Develop, write, and manage technical nonclinical documents, including eCTD Module 2.4 and 2.6 documents, Investigator’s Brochures, nonclinical study reports, meeting requests, briefing documents, and responses to questions.
• Lead projects independently and define the structure, content, and messaging of nonclinical documents.
• Author documents using GLP and non-GLP study reports, in vivo and in vitro data, pharmacokinetics, pharmacology, and toxicology information.
• Create mapping plans for the placement of nonclinical studies within eCTD Modules 2.4 and 2.6.
• Ensure submission packages align with regulatory guidelines and maintain scientific integrity.
• Collaborate with project management, safety, efficacy, biostatistics, regulatory operations, and CMC teams, as well as lead client meetings.

Requirements

• Bachelor’s degree or higher in pharmacology, toxicology, biology, chemistry, or a related field.
• At least 2 years of pharmaceutical regulatory nonclinical writing experience.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, including FDA and EMA guidance.
• Strong writing, analytical, communication, organizational, and project management skills.
• Experience working with nonclinical and pharmaceutical development data, including pharmacokinetic and toxicology reports.
• Proficiency with Microsoft Office applications.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.
• Experience with SharePoint, Veeva RIM, PleaseReview, EndNote, client templates, and related systems.
• Understanding of CRO operations and the drug development process.

Culture & Benefits

• Full-time remote work for candidates based in the UK.
• Collaborative and inclusive work environment.
• Opportunity to work with pharmaceutical, biotech, and medical device organizations on complex regulatory submissions.
• Participation in a global clinical research organization operating across four continents.