E-DRUG: Call for consultant - WHO Regulatory Systems Strengthening Team
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Purpose of the Consultancy (one position)
The consultant will work in the Country Regulatory Strengthening (CRS) group in the Regulatory Systems Strengthening (RSS) team focusing on capacity building of the targeted countries national regulatory authorities (NRAs) through continuation of the development of the WHO global benchmarking tool (GBT), assessment of prioritized regulatory systems to identify strengths and gaps, development of institutional development plans (IDP) to build upon the identified strengths and address the gaps.
The consultant would also be monitoring progress and assessing impact as well as regular follow ups on IDP implementation. The incumbent will interact with the Regulatory Networks and Harmonization (RNH) Group and the Coordinator's Office to align RSS programme priorities with actual implementation. The incumbent may interact with RSS implementation partners inside and outside the Organization
Work to be performed
The consultant will assist the CRS group in building the capacity of the medical products regulatory system in selected and prioritized Member States through assistance in revision of the WHO GBT and manual with consideration and integration of other WHO tools (e.g. medical devices tool and blood assessment tool) as well as other relevant tools (e.g. WHO good manufacturing practices inspection management system 'GMP IMS'). He/she would participate in planning for NRA benchmarking including observed audits and vigilance field visits along with formulation of institutional development plans (IDPs), in addition to different activities for implementation of the agreed and established IDPs, and contribution to the development of the relevant WHO guidelines.
Required qualifications:
Bachelor's degree in pharmacy
Language requirements: Expert level English
Required experience:
At least 5 years of professional experience of working in the area of regulation of essential medicines and other health technologies acquired by working in NRA or pharmaceutical /biological manufacturer or other relevant institution. At least 5 years of experience in regulatory processes (inspections is required). Scientific background in regulation of medical products.
Skills:
- Knowledge of the five-step capacity building model, the WHO NRA assessment and benchmarking tools along with the associated IDP elaboration.
- Good knowledge of quality management principles and good practices (e.g. GMP, GDP, GCP, etc.)
- Effective in organizing, facilitating and conducting country visits, workshops, trainings, and other regulatory capacity building activities.
- Advanced ability to prepare written reports, terms of reference, and other documents (in English).
- Excellent ability to communicate and work in diverse cultural settings.
- Computer proficiency beyond the basics, particularly office environment (Excel, Word, PowerPoint).
- Knowledge of electronic information management applications: SharePoint, and the NRA activity planning and monitoring system (APMS).
Contract duration:
1 August 2019 - 31 December 2019
Location:
The consultant would be expected to work from home, with to travel to Switzerland and other countries according to the CRS 2019 work plan.
How to apply:
Please send your curriculum vitae by electronic mail to WHO/RHT/RSS, khadembroojerdia@who.int only with the following title - Call for consultant RSS/CRS.
The deadline is 15 July 2019.
Only selected candidates will be contacted (individually) by the WHO Secretariat.
Dr Samvel AZATYAN
Group Lead
Regulatory Networks and Harmonization [RNH]
Regulatory Systems Strengthening [RSS]
Regulation of Medicines and Other Health Technologies [RHT]
Access to Medicines, Vaccines and Pharmaceuticals [MVP]
World Health Organization
Geneva, Switzerland
"AZATYAN, Samvel" <azatyans@who.int>