[Hiring] Senior Nonclinical Writer @MMS

Role Description

This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position for candidates based out of the UK.

• Strong experience with development and writing of nonclinical documents (e.g., Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
• Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
• Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data
• Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents
• Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (e.g., Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports)
• Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC
• Demonstrated ability to lead others to complete complex projects
• Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines
• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
• Organizational expert within the nonclinical subject area
• Excellent written/oral communication and strong time and project management skills
• Ability to attend regular team meetings, lead client meetings and CRMs
• Ability to work in various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
• Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (e.g., ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)

Qualifications

• 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