Partners’ coordination

BACKGROUND

National regulatory authority (NRA) has the duty to ensure that available medical products, whether imported or manufactured locally, are of assured quality, safe and efficacious.  The NRA ensures that the licence holders adhere to approved standards of good practices and quality specifications to the approved products.

Development in vaccines and biological products has been extremely rapid in recent years, and the potential value of such products in improving health care on a global scale is immense. There is an urgent need to match technological advances with appropriate mechanisms for assuring the safety, quality and efficacy of these products.

The position is envisaged to assist WHO’s coordination and secretariat role for actively engaging priority countries in the Region in coordination with WHO Country Offices, and communication and coordination with donors and development partners to support regulatory systems strengthening.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY
The consultant will assist WHO secretariat in mobilizing resources and enhancing partnership with donors in the area of regulatory systems strengthening by monitoring donor-funded projects in priority countries in coordination with country office counterparts, assisting donors’ performance evaluation of selected countries, preparing donor report, and new project proposals.

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

• To provide assistance in the planning, implementation, monitoring and reporting of donor projects on regulatory systems strengthening in 2019-2020;
• to provide assistance in communication and coordination with the donor and technical partners within and outside of WHO for long term proposal for 2020 to 2025;
• to provide assistance in capacity building for clinical trial authorization and oversight for countries which do not have established the regulatory function.

METHODS TO CARRY OUT THE ACTIVITY

Under the supervision and guidance of the Medical Officer, RSS, EMT, DHS at the WHO Regional Office for the Western Pacific, the consultant will have to deliver the following:

• draft midterm donor reports from six budget centres including five Asian beneficiary countries in 2019-2020;  
• draft donor proposal from  budget centres including Asian and Pacific beneficiary countries; and
• z consultancy report including recommendations for strategic support to countries.

QUALIFICATIONS & EXPERIENCE

EDUCATION

Essential:  University degree or higher in Medicine, Pharmacology, Chemistry or Biologicals or health-related sciences

Desirable: post- graduate degree or experience in quality management system

EXPERIENCE

Essential: more than five years of proven professional and working experience in clinical research or regulation of medical products and developing and managing systems within a medicine regulatory authority in developing countries and/or international organization is highly desirable

Desirable: Experience in development and management of systems within a medicine regulatory authority in developing countries and/or international organization and in benchmarking of National Regulatory Authorities and provision of trainings on marketing authorization and registration of medical products

TECHNICAL SKILLS & KNOWLEDGE

• Effective communication skills

• Sufficient knowledge on regulation of medical products (e.g. review of product dossiers for quality, safety and efficacy, pharmacovigilance, clinical trials, regulatory inspections, laboratory access and lot release, and market surveillance) is desirable
• Ability to work effectively with national regulatory authority experts and stakeholders

LANGUAGES
Fluent in English (writing, reading and speaking)

COMPETENCIES

• Good understanding of  the overall regulatory systems of medical products
• Producing results
• Moving forward in a changing environment
• Fostering integration and teamwork
• Knowing and managing yourself

ADDITIONAL INFORMATION:

     DUTY STATION:   Manila, Philippines
     ORGANIZATION:  WHO Western Pacific Regional Office
     TYPE OF CONTRACT:  Consultancy
     APPLICATION DEADLINE:   28 May 2019
     STARTING DATE: 15 July 2019 (subject to confirmation)
     DURATION OF CONTRACT:  6 Months

APPLICATIONS

Qualified and interested specialists should submit their CV, Expression of Interest and offer sheet on a monthly and daily rate basis in USD to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 28 May 2019. 

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please use Tender Notice No. WPRO/2019-05/DHS_EMT/TN90487/vrs as subject to all submission.  Only successful candidates will be contacted.