Remote Lead Nonclinical Writer for Regulatory Submissions

MMS; Raleigh (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

MMS is seeking a Regulatory Writing professional to join our remote team. The role focuses on development, writing, and management of highly technical nonclinical documents, including Module 2.4 and 2.6 eCTD submissions, IBs, and GLP data.

You will lead projects, ensure regulatory alignment, and communicate findings with sponsors and cross-functional teams. Ideal candidates will have a BS in a relevant field, 2+ years of regulatory nonclinical writing experience, and strong knowledge of GLP, ICH

Qualifications

• BS required in pharmacology, toxicology, biology or chemistry.
• 2+ years pharmaceutical regulatory nonclinical writing.
• Knowledge of GLP and ICH guidelines.
• Proficiency with MS Office.
• Experience with CROs and the drug development process.

Responsibilities

• Develop and manage nonclinical documents (Module 2.4/2.6).
• Lead writing projects with minimal oversight.
• Interpret PK/TK and toxicology data.
• Map nonclinical studies within eCTD structure.
• Collaborate with cross-functional teams.
• Attend client meetings and manage timelines.

Skills

Nonclinical writing

Regulatory writing

Project leadership

Cross-functional collaboration

Regulatory guidelines

Education

BS in pharmacology/toxicology/biology/chemistry

Tools

SharePoint

Veeva RIM

EndNote

PleaseReview

Job description

MMS is seeking a Regulatory Writing professional to join our remote team. The role focuses on development, writing, and management of highly technical nonclinical documents, including Module 2.4 and 2.6 eCTD submissions, IBs, and GLP data.

You will lead projects, ensure regulatory alignment, and communicate findings with sponsors and cross-functional teams. Ideal candidates will have a BS in a relevant field, 2+ years of regulatory nonclinical writing experience, and strong knowledge of GLP, ICH