E-DRUG: Consultancy - Support to Director, Regulation & Prequalification (RPQ) & RPQ Unit Heads
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Dear Colleagues,
The Department of Regulation and Prequalification (RPQ) is looking for a consultant to provide support to Director, Regulation and Prequalification (RPQ) Department and to RPQ Unit Heads.
Background
The consultant would provide support to the Director, Regulation and Prequalification (RPQ) and RPQ Unit Heads in several projects described in objectives.
This support would include up to 100 percent of a work week. The consultant will be required to work with experts within the RPQ Department and other Departments and Units within the Division along with WHO Regional and Country Offices, partners and stakeholders in relation to technical projects. The consultant will provide technical support to the Director RPQ in cross-cutting activities throughout the Department.
Consultants profile:
The consultant must have the following skills, experience and qualifications:
- Extensive knowledge of regulatory work in the area of quality in the pharmaceutical industry and/or regulatory authority.
- Excellent ability to communicate and work in diverse cultural settings. Advanced computer literacy and knowledge of regulatory IT systems and databases.
- Good professional drafting and communication skills.
- Experience related to the training of regulators from low and middle-income countries.
- Expert knowledge of English is essential. Ability to work in other UN languages would be an asset.
- At least ten years of national and international professional experience working in the area of regulation of medical products within the pharmaceutical industry and/or regulatory authority. Good overall knowledge of regulatory requirements.
- Experience of working in collaboration with the World Health Organization would be an advantage in order to understand WHO's roles and core functions.
- Experience in the implementation and management of collaborative projects in the regulatory field.
- Undergraduate degree in science, economics, pharmacy or other health profession, social sciences, political science or international development, plus advanced university degree in science, management or social sciences.
Objectives and methodology of the work to be performed:
- To perform some or all of the below mentioned duties as per the skill set of the chosen consultants.
- Support coordination of selected activities of the RPQ Department.
- Assist with transformation and change management projects related to RPQ activities.
- Assist with the development of frameworks and guidance such as the framework for operationalization of the WHO Listed Authorities, Good Reliance and Good Regulatory practices.
- Assist RPQ in the revision and improvement of joint assessment procedures and harmonized regulatory requirements to support regional initiatives.
- Assist with the review and further development of guidelines and tools for regulatory preparedness and response during public health emergencies.
- Provide technical support and assistance with coordination of exchange of information within the Department and other concerned divisions and external partners on Emergency related work (including response to COVID-19).
- Assist in development of operational guidance of WHO Centres of Regulatory Excellence and Training.
- Assist in development of appropriate KPIs to monitor improvement made by countries as a result of WHO's work.
- Assist in development of a risk mitigation plan in coordination within other Departments within MHP as well as other relevant divisions, departments and regional offices.
- Support the communication team to develop advocacy materials which highlight RPQ achievements and impact made at country level.
- Support the IT work to integrate global and regional platforms to share the results of RPQ work.
- Respond to other ad hoc requests as appropriate within RPQ.
Time frame:
Contract dates: TBC
Location of work:
The consultant will be home-based with travel to WHO headquarters.
Only selected candidates will be contacted (individually) by the WHO Secretariat.
Application:
Curriculum vitae/Stellis profile should be submitted to WHO/RPQ by electronic mail to donagherc@who.int with the following title:
"Request for Proposal HQ/MHP/RPQ"
The deadline for applications is 1 June 2020 @ 17h00 Geneva time.
Dr Samvel AZATYAN
Team Lead
Regulatory Convergence and Networks [RCN]
Team Lead a.i., Facilitated Product Introduction [FPI]
Regulation and Safety [REG]
Regulation and Prequalification [RPQ]
World Health Organization
Geneva, Switzerland
"AZATYAN, Samvel" <azatyans@who.int>