Operations and Support Specialist - Clinical

Responsibilities

• Support R&D teams with operational management and the use of R&D systems
• Act as a conduit between system end users and technical teams to enhance regulatory solutions
• Collect, maintain, and prioritize user requirements for applicable applications
• Manage system access plans and user account oversight activities
• Provide complex query support and troubleshooting for system errors or failures
• Ensure GxP requirements and inspection readiness are maintained
• Support audit, assessment, and inspection readiness, including internal and external inspections
• Manage the preparation, maintenance, and execution of user acceptance test scripts
• Assist in managing projects from initiation through completion, including planning and resourcing
• Contribute to the development and maintenance of written standards and training content

Requirements

• Bachelor's degree in life sciences, information technology, or a related field
• 5 years of experience in the pharmaceutical or consumer goods industry
• Minimum of 2 years of experience in a Regulatory or related field
• Experience in system configuration, preferably with Veeva Vault systems
• Experience working with validated document management systems
• Proven understanding of regulatory, pharmacovigilance, or clinical research processes
• Knowledge of FDA, EMA, PMDA, MFDS, NMPA, ICH GVP, and GxP regulations
• Experience with JIRA backlog and requirement management

Preferred Qualifications

• Technical background and proficiency in pharmacovigilance, regulatory, or clinical systems
• Experience working within Agile delivery methodologies
• Strong interpersonal, written, and verbal communication skills
• Ability to communicate professionally with both technical and non-technical audiences
• Self-motivated with the ability to resolve issues with minimal supervision

About the Company

Haleon is a purpose-driven, world-class consumer company dedicated to putting everyday health in the hands of millions. With a trusted portfolio of brands including Sensodyne, Panadol, Advil, and Centrum, Haleon combines deep human understanding with trusted science to deliver better everyday health with humanity.