Senior Nonclinical Writer - Remote UK

MMS Holdings Inc; Belfast City District; Remote; GBP 65,000 - 90,000; Full time

Job summary

MMS Holdings Inc is seeking a seasoned regulatory nonclinical writer to join our remote UK team. You will develop and manage highly technical nonclinical documents for INDs/CTAs/NDAs/MAAs, aligning with GLP, ICH, FDA and EMA guidelines.

You will lead projects, collaborate with cross-functional teams, and mentor others while ensuring scientific integrity and sponsor-specific formats. This full-time role offers flexibility and the opportunity to contribute to cutting-edge regulatory submissions

Qualifications

• BS+ in pharmacology, toxicology, biology or chemistry with regulatory writing experience.
• Knowledge of GLP, ICH guidelines and applicable regulatory requirements.
• 5+ years of pharmaceutical regulatory nonclinical writing experience.
• Proficiency with MS Office applications; CROs experience preferred.

Responsibilities

• Develop and write nonclinical submission documents (Module 2.4/2.6 eCTD).
• Lead projects independently, ensuring scientific integrity and sponsor alignment.
• Collaborate with cross-functional teams (PM, safety, regulatory, biostats, CMC).
• Attend team and client meetings; adapt documents to sponsor formats.

Skills

Strong writing

Analytical skills

Time management

Communication skills

Education

BS in pharmacology, toxicology, biology or chemistry

Tools

MS Office

SharePoint

Veeva RIM

EndNote

Job description

MMS Holdings Inc is seeking a seasoned regulatory nonclinical writer to join our remote UK team. You will develop and manage highly technical nonclinical documents for INDs/CTAs/NDAs/MAAs, aligning with GLP, ICH, FDA and EMA guidelines.

You will lead projects, collaborate with cross-functional teams, and mentor others while ensuring scientific integrity and sponsor-specific formats. This full-time role offers flexibility and the opportunity to contribute to cutting-edge regulatory submissions