Senior Nonclinical Writer — Remote Regulatory Submissions

Comunidade Metodista; Nashville (TN); Remote; USD 85,000 - 125,000; Full time

Job summary

MMS is seeking a Nonclinical Writer to develop and manage highly technical nonclinical documents for regulatory submissions. You will lead writing efforts for modules 2.4 and 2.6, IBs, and study reports, ensuring alignment with GLP, ICH, and sponsor requirements.

Ideal candidates have a BS in pharmacology, toxicology, biology, or chemistry and at least 2+ years in regulatory nonclinical writing, with strong writing and analytical skills and MS Office proficiency.

Qualifications

• Strong writing and analytical skills.
• Experience in regulatory writing within pharmaceutical nonclinical area.
• Basic understanding of CROs and drug development processes.

Responsibilities

• Develop, write, and manage highly technical nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, IBs, Nonclinical Study Reports).
• Lead projects independently with minimal oversight, ensuring regulatory compliance and scientific integrity.
• Interpret and analyze pharmacokinetics, pharmacology, and toxicology data for document development.
• Coordinate with cross-functional teams to align nonclinical packages with sponsor formats and guidelines.

Skills

Strong writing

Analytical skills

Project management

MS Office proficiency

Education

BS in pharmacology/toxicology/biology/chemistry or related field

Tools

MS Office

Job description

MMS is seeking a Nonclinical Writer to develop and manage highly technical nonclinical documents for regulatory submissions. You will lead writing efforts for modules 2.4 and 2.6, IBs, and study reports, ensuring alignment with GLP, ICH, and sponsor requirements.

Ideal candidates have a BS in pharmacology, toxicology, biology, or chemistry and at least 2+ years in regulatory nonclinical writing, with strong writing and analytical skills and MS Office proficiency.