Senior Nonclinical Writer (Remote - UK)

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges.

Requirements

• Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
• BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control
• Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
• 2+ 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 scientific & nonclinical data/terminology, & the drug development process