Principal Scientist - Toxicology

Job Description Summary

This role will provide scientific and operational support to Study Quality and Compliance group within PreClinical Safety (PCS) function.

 

Job Description

Major Accountabilities:

• Ensuring PCS compliance with training records, CV, and JDs.
• Ensure all documentation is consistent with GLP requirements.
• Support periodic review and maintenance of PCS SOPs.
• Maintain good working knowledge of any company SOPs that influence or impact the PCS SOPs.
• Get necessary input/feedback from relevant stakeholders to keep documentations up-to-date·
• Create and perform quality checks on SEND packages for FDA submissions
• Support electronic laboratory notebook compliance ensuring the necessary reviews and compliance with company guidelines
• Support the Study Quality and Compliance team’s effort for tracking and managing study-related information in a global online fashion by leveraging the use of software tools to enhance productivity and information sharing.

Minimum Requirements:

• Graduate/ Postgraduate in Life Sciences with 10-15 years relevant experience working in pharmaceutical GLP setting.
• Good working knowledge of regulatory compliance requirements
• Knowledge of animal welfare requirements related to study conduct

• Previous experience creating and reviewing SEND packages
• Good communication skills, and excellent logistical/planning skills
• Previous experience with software for online information and program management is a plus

 

Skills Desired

Animal Models, Bioinformatics, Collaboration, Communication Skills (Inactive), Data Analysis, Ethics, Laboratory (Inactive), Problem Solving, Regulatory Compliance, Researching, Risk Assessments, Toxicology

Global pharmaceutical company focused on innovative medicines in oncology, immunology, and neuroscience. Headquartered in Basel, Switzerland.

novartis.com