ROLE SUMMARY
Reporting directly to the Acting Regulatory Enablement Manager, the role of the Case Manager will be to provide support to the Acting Regulatory Enablement Manager and:
o To ensure the efficient case creation, scheduling, management and processing of applications assigned to the group e.g., Variations (National, MR, Worksharing), Scientific Advice, New applications and Renewals.
o Act as “Business Owner” or “Subject Matter Expert” on key departmental projects and technological support systems as required
o Provide leadership, support, and management of assigned staff within the section
o Contribute to the continual development of the section
The Case Manager will work closely with the:
o Other leaders and managers within the Regulatory Enablement section
o Director of Human Products Authorisation & Registration and management team
KEY RESPONSIBILITIES
- Strategic Objectives
o Supporting the Acting Regulatory Enablement Manager in the management and on-going development of the section.
o Work closely with the other managers in the section and management team to ensure these teams have access to efficient and effective administrative support.
o Work with the Acting Regulatory Enablement Manager and other managers within the section to develop strategic plans for the section.
o Contribute and provide support to projects within the section as required.
o Manage and develop assigned staff in the section.
o Work with colleagues in the section to prioritise objectives and to ensure that the strategic goals of the section are achieved.
- Operational Management
o Work with assigned team to organise, plan and manage work allocated to teams.
o Ensure project management is provided for any cases as required
o Monitor progress and status of cases including adherence to timelines.
o Manage the quality and volume of output for the team including monitoring and improving quality standards.
o Compilation of statistical data analysis as required and reporting regularly on progress against specified targets and objectives.
o Attend and contributing to meetings of the Human Products Authorisation & Registration department.
o Ensure the correct utilisation of IT systems e.g., EOLAS, Docubridge, CTS, CESP, and other systems to support the efficient licensing of applications
- Quality and Knowledge Management
o Ensure that the procedures and policies of the HPRA Quality Management System are deployed and adhered to within the section.
o Work with the management team of the section and other colleagues to develop and create standard operating procedures and practices in particular for new processes.
o Participate and managing the involvement of the team in any internal audits including the identification and implementation of any required corrective actions.
o Ensure that available information and knowledge across the HPRA is effectively used by the team.
- Performance Management
o Work with the Acting HPAR Regulatory Enablement Manager to set appropriate performance targets for the teams.
o Effective communication of goals, objectives, and performance targets to the team.
o Co-ordinate and participate in the performance development programme (PDP) within the team.
o Work with the section and other colleagues to promote effective performance within the Business Process Co-ordination Section.
o Take measures to identify and resolve issues impacting performance.
o Recognise good performance and promoting a culture of performance improvement within the section.
o Prepare individual training plans for inclusion in annual organisation training plan.
o Act as the ‘business owner’ or “Subject Matter Expert” for the various projects, workflow, and technological support systems within the department
- Communications/Customer Service
o Provide timely feedback to team members.
o Represent the views of the team to the wider organisation.
o Attend and contributing to internal and external meetings, as appropriate.
o Work with team to ensure delivery of efficient and effective customer service.
o Ensure responses to queries in line with the service charter.
- HR/People Management
o Manage and supervising the teams.
o Work with HR, the Acting Regulatory Enablement manager and other colleagues as required, managing the recruitment and selection of the section.
o Liaise with HR to provide front line HR management of staff (e.g., managing flexitime, annual leave, probationary reviews etc.)
o Provide support to all staff members of the section.
o Ensure the provision of high-quality induction and ongoing training for staff, including on the job training.
o Oversee the development of staff, including the development with HR, of individual training plans, and maintenance of training records and documentation.
- General
o Represent them at external meetings as required
o Deputise for the Acting Regulatory Enablement Manager, as appropriate
QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have:
o 2 years relevant office/administration experience
o Substantial knowledge of workflow and information systems, including ability to manage and report on various performance indicators and metrics
o Previous experience managing a team
o Proven ability to manage high and diverse workloads
o Flexibility to adapt to changing priorities and take responsibility to ensure that a successful outcome is achieved
o Excellent planning and organisational skills
o Proven communication and leadership skills and ability to motivate and lead a team
o Excellent analytical and proven problem-solving ability
o Experience as author for documents in the QMS system
o Proven ability to use initiative and work unsupervised
In addition to this, the ideal candidate will have:
o Good understanding of National and European procedures and timelines, together with related policies and legislative requirements
o Understanding of the licensing processes for human medicinal products
o Project management experience
o Understanding of Lean Six Sigma and Continuous Improvement
o Ability to negotiate and make decisions
o Ability to engage with employees and understand their needs
o Ability to motivate a team to maintain output and productivity
REMUNERATION
Salary: €51,718 - €61,866 per annum (incremental scale)
Candidates should note that entry will be at the minimum of the scale and the rate of remuneration may be adjusted from time to time in line with Government pay policy.
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