Senior Nonclinical Regulatory Writer — Impactful Trials

MMS; England; Remote; GBP 40,000 - 60,000; Full time

Job summary

A clinical research organization in the UK is seeking a Regulatory Writer with experience in developing nonclinical documents. The successful candidate will lead projects, ensuring compliance with regulatory standards, while collaborating with cross-functional teams. A BS in a relevant field and over 2 years of experience in regulatory writing are required. This role offers opportunities for professional growth in a supportive environment.

Qualifications

• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• Proficiency with MS Office applications.

Responsibilities

• Lead the writing of nonclinical documents ensuring alignment with regulatory guidelines.
• Interpret and analyze pharmacokinetics and toxicology data.
• Collaborate with cross-functional teams on project deliverables.

Skills

Regulatory writing

Analytical skills

Communication skills

Project management

Education

BS in pharmacology, toxicology, biology or chemistry

Tools

MS Office

Job description

A clinical research organization in the UK is seeking a Regulatory Writer with experience in developing nonclinical documents. The successful candidate will lead projects, ensuring compliance with regulatory standards, while collaborating with cross-functional teams. A BS in a relevant field and over 2 years of experience in regulatory writing are required. This role offers opportunities for professional growth in a supportive environment.