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Consultant – Regulatory Systems Strengthening – Technical guidance to National Regulatory Authorities (NRAs).

Anywhere

  • Organization: WHO - World Health Organization
  • Location: Anywhere
  • Grade: Consultancy - International Consultant - Internationally recruited Contractors Agreement
  • Occupational Groups:
    • Public Policy and Administration
  • Closing Date: Closed

Purpose of consultancy

The consultant will conduct desk research of the information managements systems (IMS) currently available and utilized by regulatory authorities worldwide. The consultant will perform some or all of the below mentioned duties as per the skill set of the chosen consultant.

Background

Digital technologies are now integral to daily life, and the world’s population has never been more interconnected. Innovation, particularly in the digital sphere, is happening on an unprecedented scale. Even so, its application to improve the health of population remains largely untapped, and there is an immense scope for use of digital health solutions. Digital health can help make health systems more efficient and sustainable, enabling them to deliver good quality, affordable and equitable care and also ensure access to affordable, quality assured, safe and effective medical products. Information Management Systems (IMS) along with digitalization is indeed one key enabler of the regulatory activities and will improve several Good Regulatory Practices (GRP) principles.

This desk research aims at assisting and guiding WHO, WHO partners and the Member States (particularly in developing countries) in developing policies and guidelines as well as utilization and application of best practices for regulatory IMS.
The objectives are to:

1. Identify the regulatory functions and activities supported by IMS.
2. Map the existing regulatory IMS used by targeted NRAs.
3. Identify gaps in availability or utilization of regulatory IMS.
4. Elect a set of recommendations to advise on any policy development and address the gaps and build upon acknowledged strengths and best practices.
5. Share the findings of the research in the form of a scientific article to be published in one peer reviewed journal.

This work may be complemented in the near future with other work on identification of minimum standard of regulatory IMS, guidance on development of and rolling out of IMS for different regulatory functions and others.

The research methodology should be agreed upon before commencement of the work. Nonetheless, this should be a desk based research by reviewing publicly available literature and publications along with publicly available information from targeted NRAs (e.g., website, gazette, etc.), as well as information collected during WHO self-benchmarking or official benchmarking of NRAs. The research does not involve any sort of targeted survey or questionnaire of the NRAs.

Deliverables

Deliverable 1 Detailed research report including raw data, all findings and recommendations.
Expected by: Should be finalized within 4 months from the commencement of the work.

Deliverable 2 Draft scientific article ready to be published in a peer reviewed scientific journal.
Expected by: Should be within 4 months from the commencement of the work.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

Advanced University degree in pharmacy, medicine, pharmacology, chemistry, biochemistry, microbiology, management or other health related sciences.

Experience:

Essential:

At least seven years of national, regional or international experience working in the area of regulation of medical products within a regulatory authority and/or related entities.

Desirable:

Experience working in collaboration with the World Health Organization in order to understand WHO’s roles and core functions.

Skills/Knowledge:

  • Extensive knowledge of regulatory systems strengthening for medical products in the regulatory authority and/or pharmaceutical industry.
  • Good overall knowledge of the WHO global benchmarking tool, methodology and related guidelines.
  • Good overall knowledge about automation and digitalization of regulatory activities, as well as information management systems used by regulatory authorities.
  • Excellent ability to communicate and work in diverse cultural settings.
  • Advanced computer literacy and knowledge of regulatory Information Technology, Information management Systems and digitalization of regulatory related activities.
  • Good professional writing and communication skills.
  • Advanced skills and proficiency in literature review and desk-based research.

Languages required:

Essential:

Expert knowledge of English and/or French.

Desirable:

Knowledge of other UN languages.

Location

Off-site – Home based.

Travel

The Consultant may need to travel to WHO headquarters.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level B - USD 7,000 - 9,980 per month.

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

4 months.

Additional Information

  • This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
  • Only candidates under serious consideration will be contacted.
  • A written test may be used as a form of screening.
  • If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
  • For information on WHO's operations please visit: http://www.who.int.
  • WHO is committed to workforce diversity.
  • WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
  • Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
  • WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
  • WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
  • Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
  • WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
  • Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html
This vacancy is now closed.
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