E-DRUG: WHO call for consultancy: Global Competency Framework for Regulators
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WHO call for consultancy: To assist with the piloting of the competency framework and further development of the Global Competency Framework for Regulators
Background
The Access to Medicines and Health Products Division works with the Member States and partners to improve access to essential medicines and other health technologies of assured quality, safety, and efficacy. The division works with a wide range of UN organizations, international partners, experts, networks, and WHO Collaborating Centres.
The Regulation and Prequalification Department (RPQ), covering medicines, vaccines, other biologicals, blood products, medical devices, and diagnostics, consists of two Units covering the prequalification of medicines, vaccines, vector control products, and diagnostics for UN and international procurement, the strengthening of regulatory systems and networks, and the safety and vigilance of health technologies. RPQ is also responsible for detecting and preventing substandard and falsified (SF) medical products.
Lack of regulatory expertise in sufficient numbers impacts access to quality, safe and efficacious, especially in low- and middle-income countries (LMICs). While WHO established a well-recognized process for benchmarking and strengthening regulatory systems, there is a growing recognition to include a common global competency framework in regulatory capacity building to achieve the desired public health outcomes. As a result, WHO is working with partners to develop a global competency framework and curricula to support the training and professional development of regulatory staff.
The global competency framework and curricula ensure harmonized and quality performance standards for regulatory activities as part of regulatory systems strengthening. It outlines recommendations for the competency requirements for regulators across the essential functions and maturity levels, as defined by the Global Benchmarking Tool (GBT), a tool to guide countries through gap analysis and systematic institutional development. The maturity model in the GBT represents a tool for a national regulatory authority's (NRA) development and a continuum of the NRA's capabilities in performing regulatory functions. Thus, the competency framework allows competency modelling by individual NRAs across the maturity levels, particularly levels 1 to 3, aligning individual capabilities with the organizational strategy and business processes.
Consultant Profile
Qualifications required
Advanced degree in pharmacy, medicine, life sciences, educational psychology, other health-related or social science fields.
Skills/Technical skills and knowledge
- Strong technical and regulatory knowledge in the regulation of medical products.
- Strong technical knowledge of competency frameworks and performance management.
- Strong technical knowledge in WHO and other internationally recognized quality assurance standards and health product regulation.
- Excellent technical writing skills.
- Good communication and interpersonal skills, and the ability to work in a multicultural team and maintain effective working relationships with recognized experts and stakeholders.
- Strong methodological and analytical skills, and the ability to conduct research, identify and analyse literature relevant to the programme area.
- Good planning and organizational skills with attention to detail and the ability to multi-task and work under pressure.
- Strong IT skills: Word, Excel, presentation software, databases, data analytic, and reporting software (e.g., PowerBI, Tableau).
Experience required
A minimum of seven years of professional experience in the pharmaceutical, life sciences, health-related field, learning and development, human performance technology, or related fields.
Desirable experience
The following would be considered an asset:
- Experience in competence assessments, workplace learning, and development, organizational performance.
- Experience in, or in collaboration with, an international organization.
- Experience working in LMICs.
Languages
- Expert knowledge of English.
- Working knowledge of another WHO official language would be an asset.
Nature and objectives of the work to be performed:
Under the supervision of Team Lead, Facilitated Product Introduction, consultants will undertake the following work:
Activity 1: Developing implementation tools
- Activity 1.1: Develop and update competence assessment tools for specific regulatory activities/functions.
- Activity 1.2: Develop a draft competency implementation manual for NRAs and regional economic communities (RECs) involved in the joint assessment and GMP inspection activities.
Activity 2: Piloting of the competency framework
- Activity 2.1: Facilitate piloting the competency framework with individual NRAs, and RECs involved in joint activities (dossier assessments and GMP inspections).
- Activity 2.2: Facilitate individual NRAs/RECs to adapt the global competency framework suitable for their context.
- Activity 2.3: Facilitate individual NRAs / RECs to perform competence assessments, skill-gap analysis, and drafting training plans.
- Activity 2.4: Data analysis and reporting of the pilot competence assessments.
Activity 3: Updating the competence framework based on public and stakeholder consultation
- Activity 3.1: Updating the competency framework based on feedback from public consultation and ongoing piloting of the framework.
Deliverables:
- Updated competence assessment tools.
- Draft competency implementation manual for NRAs and regional economic communities (RECs) involved in the joint assessment and GMP inspection activities
- Progress report(s) on piloting the competency framework with individual NRAs and REC(s)
- Updated competency framework based on feedback from the pilots and stakeholder consultation.
Time frames:
Contract dates: 6 months contract from July 2021 to December 2021.
Location of work:
Remote (home-based)
Only selected candidates will be contacted (individually) by the WHO Secretariat.
Curriculum vitae should be submitted to WHO/RPQ/REG by electronic mail
to gwazal@who.int
and copied to gunlud@who.int
with the following title: "Call for consultant-GCFR RPQ/REG/FPI"
The deadline for applications is 6 July 2021.
Dr Samvel AZATYAN
Team Lead
Regulatory Convergence and Networks [RCN]
Regulation and Safety [REG]
Regulation and Prequalification [RPQ]
World Health Organization
Geneva, Switzerland
"AZATYAN, Samvel" <azatyans@who.int>