Senior Nonclinical Writer - Lead Regulatory Docs (Remote)

MMS; United States; Remote; USD 105,000 - 135,000; Full time

Job summary

MMS is a data-focused clinical research organization with a global footprint. This full-time remote role, based out of the UK, focuses on development, writing, and management of highly technical nonclinical documents for regulatory submissions.

You will lead writing efforts, map nonclinical data within eCTD structures, and collaborate across project management, safety, and regulatory operations to ensure scientific integrity and regulatory compliance.

Qualifications

• BS in pharmacology, toxicology, biology or chemistry, or related field.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Strong writing and analytical skills.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process.

Responsibilities

• Develop, write, and manage highly technical nonclinical documents (Module 2.4/2.6 eCTD, IB, Nonclinical Study Reports, RTQs).
• Lead projects independently with minimal oversight, ensuring alignment with regulatory guidelines and scientific integrity.
• Author based on highly technical sources (GLP and non-GLP data) and map nonclinical studies within Module 2.4/2.6 structures.
• Interpret PK/PD/toxicology data from various reports and collaborate with cross-functional teams.
• Lead client meetings and contribute to CRMs while adhering to sponsor formats and processes.

Skills

Regulatory writing

Project leadership

GLP knowledge

Education

BS in pharmacology/toxicology/biology/chemistry

Tools

SharePoint

Veeva RIM

EndNote

Job description

MMS is a data-focused clinical research organization with a global footprint. This full-time remote role, based out of the UK, focuses on development, writing, and management of highly technical nonclinical documents for regulatory submissions.

You will lead writing efforts, map nonclinical data within eCTD structures, and collaborate across project management, safety, and regulatory operations to ensure scientific integrity and regulatory compliance.