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World Health Organization (WHO)

Roster of Consultants

The International Pharmacopoeia

( 2206082 )

Contractual Arrangement : External consultant

Contract Duration (Years, Months, Days) : 3 to 11 months

Job Posting: Jun 29, 2022, 11:52:32 AM

To develop, establish, publish and promote monographs on priority medicines (e.g. listed in the WHO Model List of Essential Medicines, recommended by specific WHO disease programmes, medicines for children, products included in the expression of interest for WHO Prequalification), active pharmaceutical ingredients and excipients, as well as general chapters, general notes, operating procedures, best practices, policies and strategies (including the work plan) for The International Pharmacopoeia.

Background

The Access to Medicines and Health Products (MHP) Division works with the Member States and partners to improve access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. The division works with a wide range of UN organizations, international partners, expert networks and WHO Collaborating Centres. In line with the GPW 13 strategic priorities and to achieve greater country impact, the Health Products Policy and Standards (HPS) Department works with the Regulation and Prequalification (RPQ) Department in the MHP division in the wider framework of access to medicines and health products and Universal Health Coverage and cooperates with the disease-oriented programmes (among others, HIV/AIDS, TB, malaria, NCDs and mental health, reproductive health and maternal and child health, immunization) and health systems-oriented programmes such as Primary Health Care. The Norms and Standards for Pharmaceuticals Team is one of eight teams in the HPS Department, MHP Division. The objective of the Team is to assure the quality and safety of health products through the development and establishment of global norms and standards and reference materials: robust quality control procedures; guidelines, and recommendations on the production and quality/safety control of essential medicines and health product; and to provide technical assistance to WHO Member States for national medicines regulatory activities.

Deliverables

Output 1: Develop, establish, revise, publish and promote monographs on priority medicines (e.g. listed in the WHO Model List of Essential Medicines, recommended by specific WHO disease programmes, medicines for children, products included in the expression of interest for WHO Prequalification), active pharmaceutical ingredients and excipients, as well as general chapters, general notes, operating procedures, best practices, policies and strategies (including the work plan) for The International Pharmacopoeia to facilitate progress toward Universal Health Coverage (UHC), including access to safe, quality, effective and affordable essential medicines for all. These outputs should be relevant/applicable to all WHO Member States and scientifically justified in a suitable format for public consultation or consideration by the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP).

Deliverable 1: Monographs and technical documents (general chapter, general notes, operating procedures, best practices, policies, and strategies (including the work plan) for The International Pharmacopoeia relevant/applicable to all WHO Member States and scientifically justified in a suitable format for public consultation or consideration by the ECSPP.

Deliverable 2: Peer-review monographs and technical documents for The International Pharmacopoeia for clarity, accuracy, correctness, comprehensiveness, scientific quality and compliance with pharmacopoeial standards and best practices and requirements for The International Pharmacopoeia to ensure suitability for public consultation or consideration by the ECSPP.

Deliverable 3: Technical report with ratings (on relevance and importance) and proposed action/resolution for each comment received from public consultation or ECSPP on the draft technical document.

Deliverable 4: Presentation of the comments received from public consultation or ECSPP on the technical documents for The International Pharmacopoeia to a group of experts for peer-review, discussion and consensus.

Deliverable 5: Revised monographs and technical documents for The International Pharmacopoeia incorporating the relevant feedback from other experts and public consultation in a suitable traceable format.

Deliverable 6: Final monographs and technical documents incorporating all the changes agreed upon during the final discussion leading to adoption by ECSPP and editorial changes in a suitable format for publication in the relevant edition of The International Pharmacopoeia.

Deliverable 7: Presentation of the draft or adopted monographs and technical documents for The International Pharmacopoeia at consultative or advocacy meetings with key stakeholders.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential: Advanced university degree (Masters level or above) in Pharmaceutical Sciences or analytical chemistry or related fields.

Desirable: PhD in Pharmaceutical Sciences or analytical chemistry or related fields.

Experience

Essential:

  • For band level C: Over ten years of relevant experience in the pharmaceutical, life sciences, or other health-related fields. Hands-on experience in an analytical quality control laboratory, including analytical method development and validations and/or preparation or evaluation of the quality part of marketing authorization applications.
  • For band level D: Over 15 years of relevant experience in the pharmaceutical, life sciences, or other health-related fields. Hands-on experience in an analytical quality control laboratory, including analytical method development and validations and/or preparation or evaluation of the quality part of marketing authorization applications.

Desirable: Relevant experience in a standard-setting environment.

Skills/Knowledge:

  • Good knowledge of pharmaceutical regulatory requirements (e.g., CTD Module 3).
  • Strong technical knowledge in pharmaceutical quality control and pharmacopoeial affairs.
  • Strong technical knowledge in WHO and other internationally recognized quality assurance standards and health product regulations.
  • Excellent technical writing skills.
  • Good communication and interpersonal skills, with the ability to work in a multicultural team and maintain effective working relationships with recognized experts and stakeholders.
  • Strong methodological and analytical skills, with the ability to conduct research, identify and analyze literature relevant to the programme area.
  • Good planning and organizational skills, attention to detail and the ability to multi-task and work under pressure.
  • Strong IT skills: Word, Excel, presentation software, databases and web navigators.

Languages required:

Essential: Expert knowledge of English.

Desirable: Working knowledge of another WHO official language.

Location

Off-site – Home based.

Travel

Travel to meetings to alternative locations.

Remuneration and budget (travel costs are excluded):

Remuneration:

  • Band level C USD 500 – 625 per day.
  • Band level D USD 626 – 720 per day.

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

N/A

Expected duration of contract:

Contract duration varies from 3 months to 11 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: (link) Some professional certificates may not appear in the WHED and will require individual review.
  • For information on WHO’s operations please visit: (link)
  • 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: (link)-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html
  • The purpose of this vacancy is to develop a list of qualified candidates for inclusion in this advertised roster. All applicants will be notified in writing of the outcome of their application (whether successful or unsuccessful) upon conclusion of the selection process. Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection to a consultant contract. There is no commitment on either side.
Tags: child health, editor, essential medicines, health systems, immunization, life sciences, malaria, mental health, ncds, primary health care, quality control, reference materials, reproductive health, social security contributions, technical writing, universal health coverage