E-DRUG: WHO is looking for consultants to support the work of the Regulatory Systems Strengthening (RSS) Team.
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DEADLINE FEBRUARY 8, 2021
One of the objectives of the WHO Regulatory Systems Strengthening (RSS) programme within the Regulation and Safety (REG) Unit under the Regulation and Prequalification (RPQ) Department is to support Member States to build strong regulatory capacity to ensure that medical products and other health technologies are accessible, affordable and meet internationally recognized standards of quality, safety and efficacy.
Robust regulatory systems are unquestionably crucial to achieve universal access to essential medicines, vaccines and other health products with several WHA resolutions backing up the mandate by WHO to strengthen them.
Most notable of these is Resolution WHA 67.20 on regulatory systems strengthening for medical products, endorsed in May 2014 . The benchmarking of regulatory systems referred to in Resolution WHA 67.20 implies a structured and documented process by which Member States and WHO can identify and address gaps with the goal of reaching a level of regulatory oversight commensurate with a stable, well-functioning and integrated regulatory system.
Under the proposed terms of reference described herein, these consultancies would include up to 100 percent of a work week. The consultants will be required to work with experts within the RSS Team and other teams within the Unit and Department and with WHO Regional and Country Offices, partners and stakeholders in relation to technical projects.
Work to be performed:
Under the supervision of the Team Lead, Regulatory Systems Strengthening, Regulation and Safety Unit, the consultant(s) will perform some or all of the below mentioned duties as per the skill set of the chosen consultant(s). Specific deliverables will be established and agreed for the selected consultant(s).
1. Assist in benchmarking of regulatory systems in priority Member States using the WHO Global Benchmarking Tool;
2. Follow up and providing technical assistance in implementation of Institutional Development Plans (IDPs) elaborated following benchmarking of regulatory systems;
3. Support development and implementation of a framework for WHO Listed Authorities (WLA), including but not limited to development of performance evaluation framework, review of comments following public consultation and piloting the WLA framework;
4. Assist in operationalization of a WHO network for regulatory systems strengthening, named the "Coalition of Interested Parties";
5. Assist in regulatory capacity building activities including planning and facilitating required workshops, including on regulatory preparedness during public health emergencies.
Qualifications required:
University degree in pharmacy, medicine, pharmacology, chemistry, biochemistry, microbiology, or other health related sciences. Postgraduate degree in pharmacy, medicine, public health or any of the above sciences or management.
Experience required:
a) For category one consultants: At least seven years of national, regional or international professional experience working in the area of regulation of medical products within the national or regional regulatory authority and/or pharmaceutical industry. Good overall knowledge of regulatory systems strengthening and the WHO global benchmarking tool, methodology and related guidelines. Experience in the implementation of collaborative projects in the regulatory field. Experience of working in collaboration with the World Health Organization would be an advantage in order to understand WHO's roles and core functions.
b) For category two consultants: At least ten years of national, regional or international professional experience working in the area of regulation of medical products within the national or regional regulatory authority and/or pharmaceutical industry. Good overall knowledge of regulatory systems strengthening and in-depth knowledge of the WHO global benchmarking tool, methodology and related guidelines. Experience in the implementation and management of collaborative projects in the regulatory field. Experience of working in collaboration with the World Health Organization is essential in order to understand WHO's roles and core functions.
Skills /Technical skills and knowledge:
Extensive knowledge of regulatory systems strengthening for medical products in the regulatory authority and/or pharmaceutical industry. 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.
Language requirements:
Expert knowledge of English and/or French is essential. Ability to work in other UN languages would be an asset.
Place of assignment: Home-based
There may be some travel, depending on COVID-19 travel restrictions - to be reviewed. Costs associated with such travel would be paid by WHO.
Time frames: Planned timelines for this consultancy will be agreed with the selected consultants starting from March 2021 and depending on the work to be performed. In terms of work effort, it should be noted that one month is equivalent to 20 days, which corresponds to full time equivalent and 100% equals to 40 hours a week or 4 weeks a month.
Only selected candidates will be contacted by the WHO Secretariat individually.
Curriculum vitae should be submitted to WHO RSS Team by electronic mail to: nra_admin@who.int
with the following title:
"Call for consultants RPQ/REG/RSS".
The deadline for submission of applications is 8 February 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>