Senior Nonclinical Regulatory Writer - Remote UK

MMS; Manchester; On-site; GBP 60,000 - 90,000; Full time

Job summary

MMS is a data-focused clinical research organization with a Great Place to Work certification. This full-time remote role is for candidates based in the UK and involves developing, writing and managing highly technical nonclinical documents including Module 2.4/2.6 eCTD submissions and Investigator’s Brochure content.

You will lead projects, collaborate with cross-functional teams, and ensure regulatory compliance with GLP, ICH and related guidelines, driving scientific integrity and timely

Qualifications

• BS in pharmacology, toxicology, biology or chemistry, or related field.
• 5+ years of pharmaceutical regulatory nonclinical writing experience.
• Knowledge of GLP and ICH guidelines.
• Proficiency with MS Office applications.
• Hands-on experience with CROs and nonclinical data terminology.

Responsibilities

• Develop, write, and manage nonclinical documents (Module 2.4 and 2.6 eCTD submission documents, 1st Edition IB, Nonclinical Study Reports, RTQs).
• Lead projects independently, writing nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs with regulatory alignment.

Skills

Regulatory writing

Project leadership

Communication

Analytical skills

Regulatory guidelines

Education

BS in pharmacology/toxicology/biology/chemistry

Tools

SharePoint

Veeva RIM

PleaseReview

EndNote

Job description

MMS is a data-focused clinical research organization with a Great Place to Work certification. This full-time remote role is for candidates based in the UK and involves developing, writing and managing highly technical nonclinical documents including Module 2.4/2.6 eCTD submissions and Investigator’s Brochure content.

You will lead projects, collaborate with cross-functional teams, and ensure regulatory compliance with GLP, ICH and related guidelines, driving scientific integrity and timely