Senior Nonclinical Writer

🕒 April 21

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

✏️ Content Writer

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MMS

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

💰 Private Equity Round on 2022-06

Pharmaceuticals • Biotechnology • SaaS

MMS is a leading data-focused Contract Research Organization (CRO) specializing in pharmaceutical and biotechnology innovation. With a strong emphasis on regulatory expertise and technological innovation, MMS provides a comprehensive range of services including regulatory submissions, data management, biostatistics support, medical writing, and pharmacovigilance. The company is known for its AI and technology-driven platforms like Datacise®, PVantage®, and Automatiqc®, which enhance efficiency and streamline clinical trial processes. MMS supports its clients from the investigational new drug application phase through to marketing authorization and post-approval, offering integrated solutions to accelerate drug development and mitigate risks. Recognized as a top workplace and for leadership in ESG sustainability, MMS is committed to empowering its employees and driving successful outcomes for its clients on a global scale.

📋 Description

• Participate in the development, writing, and management of highly technical nonclinical documents • 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) • 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 • 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 • 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 • Complete documents according to sponsor’s format, processes, and according to regulatory guidelines • 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 • Attend regular team meetings, lead client meeting and CRMs • Work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development

🎯 Requirements

• BS + in pharmacology, toxicology, biology or chemistry, or related field • 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

🏖️ Benefits

• Great Place to Work certified organization • Exceptional culture • Industry best employee retention rate