Case Manager

Job description

Case Manager (Acting)

Specified Purpose Contract (Maternity Leave Cover)
Salary: €51,718 – €61,866 per annum (incremental scale)
Location: Dublin (Hybrid – Minimum 2 days on-site)

About the Role

Orange Recruitment is seeking a highly motivated Case Manager (Acting) to work in Regulatory Enablement section of the department on a specified-purpose contract to cover maternity leave. Reporting to the Acting Regulatory Enablement Manager, the successful candidate will contribute to the strategic and operational delivery of case management services within the department.

This role offers a unique opportunity to lead and support a dynamic team responsible for the efficient processing of regulatory applications including variations, scientific advice, new applications, and renewals.

Key Responsibilities

Strategic & Operational Leadership

• Support the strategic development and management of the Regulatory Enablement section.
• Oversee case scheduling and processing to ensure timely delivery and quality standards.
• Provide leadership to assigned staff and contribute to team planning and resourcing.

Project & Performance Management

• Act as a Business Owner or Subject Matter Expert for departmental systems and projects.
• Monitor team output, ensure efficient use of IT systems (e.g., EOLAS, Docubridge, CTS).
• Compile and report performance metrics, contributing to continuous improvement.

Quality, Communication & Customer Service

• Ensure compliance with HPRA Quality Management System (QMS) procedures.
• Represent team views internally and externally, and promote strong stakeholder engagement.
• Foster a high-performance culture and maintain effective communication with staff and stakeholders.

HR & Staff Development

• Manage team resourcing, performance development, and training plans.
• Support recruitment and frontline HR activities in liaison with HR.
• Ensure high-quality onboarding and training for new and existing staff.

Essential Qualifications and Experience

• Minimum 2 years of relevant office/administration experience.
• Proven ability to manage teams and high-volume workloads.
• Strong knowledge of workflow and information systems.
• Demonstrated leadership, planning, problem-solving, and communication skills.
• Experience as a document author in a QMS system.
• Proven ability to work independently and take initiative.

Desirable Experience

• Understanding of National and European regulatory procedures and timelines.
• Knowledge of human medicinal product licensing processes.
• Project management and Continuous Improvement (e.g., Lean Six Sigma) experience.
• Ability to motivate staff and foster a positive team culture.