Senior Nonclinical Writer (Remote - UK)
RemoteUnited Kingdom
Job Summary
Develop and manage highly technical nonclinical documents, including Module 2.4 and 2.6 eCTD submissions, Investigator's Brochures, and Nonclinical Study Reports. Lead projects independently by interpreting complex pharmacokinetics, pharmacology, and toxicology data to ensure alignment with current regulatory guidelines and scientific integrity. Author content based on GLP and non-GLP study reports while developing mapping plans for eCTD structures. Collaborate with cross-functional teams on project management, safety, efficacy, and regulatory operations to negotiate and persuade stakeholders. Operate within client systems like SharePoint and Veeva RIM to deliver documents according to sponsor formats and regulatory standards.
Required 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
- Ability to attend regular team meetings, lead client meeting and CRMs
- Ability to 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 (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)
- 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 develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents
- Ability to interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports)
- 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 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 complete documents according to sponsor's format, processes, and according to regulatory guidelines
- Demonstrated ability to lead others to complete complex projects
- Ability to collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC
Desired Qualifications
- 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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