Senior Nonclinical Writer — Remote Leader

MMS Holdings Inc; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

MMS Holdings Inc. is seeking a Regulatory Nonclinical Writer for a full-time remote role.

The candidate will develop and manage highly technical nonclinical documents to support regulatory submissions, including Module 2.4/2.6, IBs, and study reports, collaborating with cross-functional teams in a fast-paced environment. Ideal candidates have 5+ years of pharma regulatory nonclinical writing experience, strong writing/analytical skills, and knowledge of GLP and ICH guidelines, with proficiency

Qualifications

• BS+ in pharmacology, toxicology, biology, chemistry or related field.
• Regulatory writing experience in pharma.
• 5+ years regulatory nonclinical writing.
• Knowledge of GLP and ICH guidelines.
• Proficiency with MS Office.

Responsibilities

• Develop and manage nonclinical submission documents (Module 2.4/2.6).
• Lead writing for INDs/CTAs/NDAs/BLAs/MAAs.
• Interpret pharmacokinetics, pharmacology, toxicology data.
• Coordinate with cross-functional teams (PM, safety, regulatory).
• Ensure documents align with regulatory guidelines.

Skills

Regulatory writing

Project leadership

Cross-functional collaboration

Attention to detail

Education

BS in pharmacology/toxicology/biology/chemistry

Tools

MS Office

Job description

MMS Holdings Inc. is seeking a Regulatory Nonclinical Writer for a full-time remote role.

The candidate will develop and manage highly technical nonclinical documents to support regulatory submissions, including Module 2.4/2.6, IBs, and study reports, collaborating with cross-functional teams in a fast-paced environment. Ideal candidates have 5+ years of pharma regulatory nonclinical writing experience, strong writing/analytical skills, and knowledge of GLP and ICH guidelines, with proficiency