JOB SUMMARY

The Scientific Writer II partners with study directors, principal investigators, and other scientific staff to generate high-quality figures, tables, protocols, and technical reports from pre-clinical drug discovery, pharmacology, and toxicology study data that help our clients make informed decisions about their drug discovery programs. The individual in this role will work across sites with scientific staff and clients to ensure the accuracy, consistency, and professional appearance of all documents while adhering to templates, standards, and project timelines.
Other responsibilities may include performing statistical analysis using GraphPad Prism, developing and maintaining templates to improve workflows and increase efficiency, and assist in formatting a variety of papers, data packages, and other deliverables.

SKILLS AND ABILITIES

• Understanding of in vivo models of multi-system rodent physiology, immunology, neuroscience, histopathology, and in vitro analyses of pathobiology and disease biomarkers (molecular pharmacology and toxicology)
• Ability to work independently as well as collaboratively with others across different company sites to ensure document accuracy, consistency, and professional appearance
• Proficient in Microsoft Office, Adobe Acrobat, and GraphPad Prism
• Follow all SOPs and other applicable laboratory or company policies and procedures
• Interact with clients, other employees, and the community in a professional manner
• Ability to adhere to all company policies, safety regulations and procedures
• Maintain confidential information
• Demonstrate Inotiv Core Values and adhere to Code of Conduct

MINIMUM EDUCATION AND EXPERIENCE

• Master’s degree or higher in a related discipline (Physiology, Pharmacology, Immunology, etc)
• At least 2 years of experience in pre-clinical in vivo models of disease
• Any equivalent combination of education and experience
• Past pre-clinical, scientific, and/or technical writing experience preferred
• Equivalent combination of related education and required work experience will be considered with Management approval

• Partner with scientific staff to produce accurate and concise protocols, reports, and data
• Setup spreadsheets or other documentation as directed by scientific staff to allow for accurate and efficient data entry
• Create, edit, and format tables and figures from applicable software programs
• Analyze and interpret data across a range of therapeutic areas
• Review protocols, reports, and other documents for spelling, grammar, clarity, and conformance with applicable templates
• Work with other departments, groups, or teams as necessary to create and issue protocols, reports, amendments, and other required deliverables
• Convert deliverables to PDF and format them in compliance with applicable FDA guidelines and Inotiv style guides and templates
• Sense of urgency to ensure that internal and external deadlines are met
• Detail-oriented and capable of producing consistent, error-free, quality deliverables
• Maintain thorough knowledge of facility SOPs, policies, study protocols, etc.
• Excellent organizational, communication, time management, and interpersonal skills in a cross-functional team
• General understanding of relevant regulations (e.g., GLP and GCP)
• Perform other duties as assigned