MMS
Senior Nonclinical Writer (Remote - UK)
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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 an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Role Overview
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.
Roles and Responsibilities
- Document Development and Writing
- 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)
- Project Leadership
- 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
- Technical Expertise
- 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 the 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)
- Collaboration and Communication
- 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 effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
- Organizational Skills
- Organizational expert within the nonclinical subject area
- Communication and Management Skills
- Excellent written/oral communication and strong time and project management skills
- Ability to attend regular team meetings, lead client meetings, and CRMs
- Technical Proficiency
- 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)
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Requirements
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- Education
- BS+ in pharmacology, toxicology, biology, or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control
- Knowledge and Experience
- Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
- 2+ years of pharmaceutical regulatory nonclinical writing experience
- Skills
- 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
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