Senior Nonclinical Writer - Remote, Regulatory Submissions

MMS Holdings Inc; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

MMS Holdings Inc. is seeking a skilled regulatory writer to join our team, focusing on nonclinical documents for regulatory submissions. You will develop, write, and manage Module 2.4/2.6 eCTD content, IBs, study reports, and briefing documents.

This full-time, remote role requires strong knowledge of GLP/ICH guidelines, excellent writing and project management skills, and the ability to lead cross-functional teams to deliver compliant submissions for INDs, CTAs, NDAs, BLAs, and MAAs.

Qualifications

• BS in pharmacology, toxicology, biology or chemistry with regulatory writing experience.
• Knowledge of GLP and ICH guidelines.
• 5+ 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 nonclinical data terminology.

Responsibilities

• Develop and manage highly technical nonclinical documents for regulatory submissions.
• Lead projects independently with minimal oversight.
• Author documents based on GLP/non-GLP data.
• Coordinate with cross-functional teams (PM, safety, efficacy, biostats, regulatory operations, CMC).
• Ensure documents meet sponsor formats and regulatory guidelines.

Skills

Regulatory writing

Nonclinical writing

Project leadership

Regulatory guidelines knowledge

Education

BS in pharmacology or related field

Tools

MS Office

Job description

MMS Holdings Inc. is seeking a skilled regulatory writer to join our team, focusing on nonclinical documents for regulatory submissions. You will develop, write, and manage Module 2.4/2.6 eCTD content, IBs, study reports, and briefing documents.

This full-time, remote role requires strong knowledge of GLP/ICH guidelines, excellent writing and project management skills, and the ability to lead cross-functional teams to deliver compliant submissions for INDs, CTAs, NDAs, BLAs, and MAAs.