Technical Officer (Facilitated Product Introduction)
OBJECTIVES OF THE PROGRAMME
The Regulation and Prequalification Department (RPQ) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. RPQ works within the Access to Medicines and Health Products Division (MHP) division departments in the wider framework of Universal Health Coverage and cooperates with disease-oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Sustainable Development Goals.
The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres. The RPQ Department has two large areas of work: Regulation and Safety, and Prequalification. The Regulation and Safety (REG) Unit which consists of six teams is covering the areas of regulatory systems strengthening, regulatory convergence and networks, facilitated product introduction, pharmacovigilance, incidents and substandard and falsified medicines and laboratory networks and services. The work of the Facilitated Product Introduction Team is based on the Global Programme of Work, as well as strategic directions provided in the Road Map for Access to Medicines, Vaccines and other Health Products 2019-2023 and WHO's five-year plan to help build effective and efficient regulatory systems -Delivering Quality-Assured Medical Products for All 2019-2023. Under Strategic Priority 1 “Strengthen country and regional regulatory systems, a goal has been defined to “implement regulation in an increasing number of countries through reliance and NRA networks” (SP 1.1), which is further broken down into seven objectives, one of which aims at ensuring an efficient and effective Collaborative Registration Procedure, inclusive of all product streams, for prequalified products and products approved by Stringent Regulatory Authorities/WHO Listed Authorities (SP 1.1.7).
DESCRIPTION OF DUTIES
Under the overall supervision of the Team Lead of Facilitated Product Introduction Team and in close collaboration with other technical Teams within RPQ Department, the responsibility of the incumbent is to contribute to improving of access to essential medical products in WHO Member States by facilitation of products introduction relying on the authoritative regulatory information available from trusted sources, e.g., WHO PQT and Stringent Regulatory Authorities/WHO Listed Authorities.
1.Ensure the day-to-day operation of the Collaborative Registration Procedure (CRP) and other types of facilitated product introduction activities (including joint activities) for medical products prequalified by WHO or approved by Stringent Regulatory Authorities/WHO Listed Authorities. Contribute to the performance of the above processes and to the shortening of regulatory approval times by developing and organizing training and other relevant capacity building activities for NRAs of WHO Member States.
2.Promote regulatory cooperation, convergence, harmonization and work-sharing through the provision of technical expertise and assistance in the development and implementation of harmonized technical requirements and guidelines.
3.Facilitate information sharing among regulatory authorities and networking. Monitoring and reporting progress of activities and provide advice on improvements to collaborative procedure processes and other types of facilitated product introduction activities (including joint activities).
4.Contribute to the reviewing, updating and establishing of technical requirements, guidelines, procedures and related quality systems for assuring the quality, safety and efficacy of priority health products, based on existing relevant WHO norms, standards and guidelines, and other existing regulatory guidance documents, as appropriate.
5.Manage projects within the area of responsibility and participate in work planning and reporting.
6.Develop, draft and finalize the standard operation procedures (SOPs) and guidelines concerning collaborative registrations, other joint activities, technical assistance and other capacity building activities.
7.Liaise with staff members in the RPQ Department, regarding the development, implementation and review of SOPs and guidelines related to the collaborative procedure and MHP normative activities.
8.Use available tools for monitoring, evaluating and reporting.
9.Support development, updating and maintenance of a documented quality system for the Team, Unit and the Department, as well as relevant tool, including databases.
10.To participate, in cooperation with other professional staff in RPQ, in other activities related to medicines quality, safety and efficacy, mainly by participating in relevant meetings and providing necessary professional advice.
- A first level university degree in pharmacy, medicine, biology, biochemistry, chemistry, microbiology or related science.
- Post-graduate degree (Master's level or above) in pharmacy, medicine, biological sciences, or other health science-related field.
- A minimum of seven years of working experience in a national regulatory authority as a medical product assessor and related professional experience with in-depth knowledge and hands-on experience of regulatory processes and technical requirements on marketing authorizations and other regulatory activities.
- Experience in the implementation and management of collaborative projects in the area of regulation of medical products and other health technologies at national and regional/ international levels.
- Experience in working with WHO Prequalification programme in assessments or inspections and with WHO guidelines and other internationally recognized technical standards and norms.
- Work experience in an international context.
- Experience in working with health products' manufacturers and regulatory authorities in low- and middle-income countries.
- Working experience in writing project proposals and successful fundraising.
- Good knowledge of regulatory work in the area of quality, safety and efficacy of medical products in national (or regional) regulatory authority and/or in the pharmaceutical industry.
- Good overall knowledge of regulatory data requirements and quality control requirements.
- Sound knowledge of WHO prequalification programme and requirements and applicable procedures.
- Sound knowledge of quality management systems applicable to regulatory authorities.
- Advanced computer literacy and knowledge of regulatory IT systems and databases.
- Good professional drafting and communication skills.
2.Respecting and promoting individual and cultural differences
5.Moving forward in a changing environment
Use of Language Skills
- Expert knowledge of English.
- Intermediate knowledge of any other official UN language
WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 75,602 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 5147 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.
- This vacancy notice may be used to fill other similar positions at the same grade level
- Only candidates under serious consideration will be contacted.
- A written test may be used as a form of screening.
- In the event that your candidature is retained for an 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.
- Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
- Staff members in other duty stations are encouraged to apply.
- For information on WHO's operations please visit: http://www.who.int.
- WHO is committed to workforce diversity.
- 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.
- WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
- WHO has a mobility policy which can be found at the following link: http://www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
- Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.