Lead Remote Nonclinical Regulatory Writer

MMS; Boston (MA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Remote work

Great culture

Job summary

MMS is a data-focused clinical research organization renowned for its culture and global reach. This full-time remote role focuses on development, writing, and management of highly technical nonclinical documents, including Module 2.4/2.6 eCTD submission components and IBs.

You will lead writing projects, interpret GLP/nonclinical data, map placements in eCTD, and ensure alignment with regulatory guidelines while collaborating with cross-functional teams across project management, safety, and

Qualifications

• BS in pharmacology, toxicology, biology, chemistry or related field with industry experience.
• Knowledge of GLP, ICH guidelines and regulatory requirements.
• 2+ years of pharmaceutical regulatory nonclinical writing experience.
• Strong writing and analytical skills.
• Proficiency with MS Office applications.

Responsibilities

• Develop and manage highly technical nonclinical documents (Module 2.4/2.6, IB, study reports).
• Lead projects independently; oversee writing, structure and messaging to regulatory standards.
• Author from highly technical sources (GLP/non-GLP data) and align with regulatory guidelines.
• Create mapping plans for nonclinical study placement within eCTD structure.
• Collaborate with cross-functional teams including project management and regulatory operations.

Skills

Nonclinical writing

Regulatory writing

Project leadership

Cross-functional collaboration

Regulatory guidelines

Education

BS in pharmacology, toxicology, biology or chemistry

Tools

MS Office

SharePoint

Veeva RIM

EndNote

PleaseReview

Job description

MMS is a data-focused clinical research organization renowned for its culture and global reach. This full-time remote role focuses on development, writing, and management of highly technical nonclinical documents, including Module 2.4/2.6 eCTD submission components and IBs.

You will lead writing projects, interpret GLP/nonclinical data, map placements in eCTD, and ensure alignment with regulatory guidelines while collaborating with cross-functional teams across project management, safety, and