Job Description

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

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