Senior Nonclinical Regulatory Writer - Remote Lead

MMS Holdings Inc; Michigan; Hybride; USD 90 000 - 130 000; Plein temps

Résumé du poste

MMS Holdings Inc., a data-focused clinical research organization, is seeking a senior regulatory nonclinical writer for a full-time remote role. You will develop, write, and manage highly technical nonclinical documents and lead projects with limited oversight.

Work includes preparing Module 2.4/2.6 eCTD submission documents, IBs, study reports, RTQs, and briefing documents, while ensuring regulatory alignment with ICH, FDA, and EMA guidelines and collaborating with cross-functional teams.

Qualifications

• BS in pharmacology, toxicology, biology or chemistry or related field.
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
• 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.

Responsabilités

• Develop and write nonclinical submission documents (Module 2.4 & 2.6 eCTD, IB, Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs).
• Lead projects independently with minimal oversight and manage writing of nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs.
• Author based on highly technical sources such as GLP and non-GLP nonclinical data.
• Develop a mapping plan for placement of nonclinical studies within Module 2.4/2.6 eCTD submission documents.
• Interpret and analyze PK/PD/toxicology data (e.g., Prism files, bioanalytical reports, pathology reports).
• Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC.

Connaissances

Regulatory writing

Project management

Leadership

Communication

Analytical skills

Formation

Bachelor's degree in pharmacology/toxicology/biology/chemistry

Outils

MS Office

SharePoint

Veeva RIM

PleaseReview

EndNote

Description du poste

MMS Holdings Inc., a data-focused clinical research organization, is seeking a senior regulatory nonclinical writer for a full-time remote role. You will develop, write, and manage highly technical nonclinical documents and lead projects with limited oversight.

Work includes preparing Module 2.4/2.6 eCTD submission documents, IBs, study reports, RTQs, and briefing documents, while ensuring regulatory alignment with ICH, FDA, and EMA guidelines and collaborating with cross-functional teams.