Senior Nonclinical Writer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Engage in the creation, composition, and oversight of complex technical nonclinical documents.

• Extensive experience in the development and drafting 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).

• Independently manage projects with minimal supervision.

• Spearhead the writing (including structure, content, and messaging) of nonclinical documents.

• Ensure the nonclinical submission package complies with current regulatory standards and maintains scientific integrity.

• Capable of authoring based on highly specialized sources.

• Formulate a mapping plan for the organization of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD submission documents.

• Analyze and interpret relevant pharmacokinetics, pharmacology, and toxicology data.

• Collaborate with interdisciplinary teams such as project management, safety, efficacy, biostatistics, regulatory operations, and CMC.

• Proven ability to guide others in completing intricate projects.

• Finalize documents in accordance with the sponsor’s formatting, processes, and regulatory guidelines.

• Operate effectively in an environment that necessitates negotiation, persuasion, collaboration, and analytical judgment.

• Recognized as an organizational expert within the nonclinical subject area.

• Exceptional written and oral communication skills along with strong time and project management capabilities.

• Participate in regular team meetings, lead client meetings, and conduct CRMs.

• Navigate various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates, and toolbars.

• Comprehensive understanding of regulatory guidelines as they pertain to nonclinical submission documents and drug development.

⛳️ Requirements

• Bachelor’s degree or higher in pharmacology, toxicology, biology, chemistry, or a related field.

• Familiarity with GLP, ICH guidelines, and relevant regulatory requirements.

• A minimum of 2 years of experience in pharmaceutical regulatory nonclinical writing.

• Strong writing and analytical capabilities.

• Proficient in MS Office applications.

• Preferred hands-on experience with clinical trials and pharmaceutical development.

• Basic understanding of CROs, scientific and nonclinical terminology, and the drug development process.

🏝️ Benefits

• Recognized as a Great Place to Work certified organization.

• Exceptional workplace culture.

• Industry-leading employee retention rate.