Purpose of the Consultancy

The main objective of this consultancy is to provide clinical guidance and lead the operational response to trauma care programmes in priority countries across the EMR. The consultant will be responsible for developing training activities, operational handbooks, and technical guidance and operational work to priority areas, and undertaking complex tasks to introduce new concepts to the region.

Planned timelines

The consultant is expected to work full time, for a period of 11 months starting on the 1st of February 2023 until 31 December 2023.   

Work to be performed: 

Under technical supervision of the Regional Trauma Specialist, the consultant will be responsible for the following key outputs

Output 1:  Lead the development of the Trauma Stabilisation Points across the EMR as a new approach to conflict settings

• Deliverable 1.1 Lead the development of the operational handbook for TSPs and provide advisory support to countries already implementing the concept   
• Deliverable 1.2 Identify and test the TSP concept in 2-3 countries, documenting results, identifying solutions, and feeding back into the TSP concept
• Deliverable 1.3 Design and deliver a regional training workshop on TSPs and establish a community of practice among leading health care professionals across the EMR

Output 2. Deliver mass casualty management training across the region, in-country and at the MCM Regional Training site

• Deliverable 2.1 Deliver the MCM WHO Academy accredited training targeting at least 150 healthcare professionals and aiming to establish a cohort of at least 50 national instructors.
• Deliverable 2.2. Support the establishment of a MCM platform to monitor impact

Output 3. Provide clinical technical leadership to TOpATs operational work with WCOs   

• Deliverable 3.1 Lead the flying trauma team for deployment to priority countries to establish a surge response to trauma needs in some of the most complex emergencies in our region
• Deliverable 3.2 Design trauma interventions and build consensus with MoH, different stakeholders and WCOs on how to implement in a timely manner 
• Deliverable 3.3. Provide expert advice to regional and global working groups and draft regional proposals

Specific requirements

Consultant should have:

Experience

• At least 10 years of humanitarian and/or military experience in delivering complex trauma programmes  
• Including experience in delivering training in low-resource and conflict settings
• Extensive experience in designing and implementing simulations in complex settings
• International experience in one of the above fields is mandatory.

Education

• Minimum an advanced university degree (Master’s degree) in trauma sciences
• MBBS and specialty in trauma is essential  

Deadline of this Job: 12 November 2022
Purpose of consultancy

The consultant will develop standard operating procedures (SOPs) for specific areas of work carried out by the Department of Regulation and Prequalification (RPQ), as well as an iLearn training module on the Quality Management System for the Department and training materials on QMS implementation for national regulatory authorities.

Deliverables

Deliverable 1: Materials developed for workshop on implementation of quality management systems for national regulatory authorities, in accordance with WHO Technical Report Series 1025 Annex 13.

Deliverable 2: Finalized overviews of quality management system documents required for each team within the RPQ Department.

Deliverable 3: Standard operating procedures (SOPs) for specific work carried out within the RPQ Department, as listed below:

• Draft cross-cutting SOP on managing incidents reported to the RPQ department.
• Finalized SOP on providing technical assistance to manufacturers and clinical research organizations.
• Finalized SOP on working with the European Medicines Agency in the Medicines for all (M4All) programme.
• Finalized SOP on managing the Collaborative Registration Procedure for medicines, vaccines and in-vitro diagnostics.
• Finalized SOP on peer audits at National Quality Control Laboratories.
• Finalized SOP on managing technical dossiers and product samples of medicines.

Deliverable 4: Provide technical input to QMS focal points within the Prequalification Unit in transposing existing SOPs into the new Quality Management System.

Deliverable 5: Develop an expanded iLearn module on the RPQ Department’s Quality Policy and Quality Manual and new iLearn module on RPQ Department’s Quality Management System for new and current staff. 

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

• Advanced university degree (Masters level or above) in Pharmacy, Pharmaceutical Sciences, Engineering or any other relevant field for Quality Management Systems.

Desirable: 

• Training in Quality Management Systems ISO9001 or any other relevant Quality Management System.

Experience

Essential:

• Over ten years of relevant experience working within Quality Management Systems – out of which five years’ experience in Quality Management Systems in a UN Organization, International Organization, Health Products Industry or National/Regional Regulatory Authority.

Desirable: 

• Experience working on Quality Management Systems in industry and relevant regulatory bodies (regulatory authority/WHO listed authority). 

Skills/Knowledge:

• Strong skills and knowledge in the field of quality management and systems.
• Excellent written and verbal communication skills, strong planning and organizational skills.  
• Strong knowledge and skills in the field of policy and strategy development.
• Demonstrated ability to work as part of a team and in diverse cultural settings