Advisor, Regulation of Vaccines and Biotechnological Products

OBJECTIVE OF THE OFFICE/DEPARTMENT

This requisition is for employment at the Pan American Health Organization (PAHO)/Regional Office of the World Health Organization (WHO)

The Department of Innovation, Access to Medicines and Health Technologies (IMT) is responsible for promoting, coordinating, and implementing the Organization’s technical cooperation in innovation, access and rational use of quality medicines and other health technologies. IMT works across all categories of medicines and health technologies, including medicines, vaccines, diagnostics, medical equipment, blood products and organs for transplantation. It provides technical cooperation to countries, addressing barriers to access within health systems and throughout the medical product life cycle, strengthening regulatory capacity and supporting evidence-based decision making and rational use through health technology assessment processes. It leads efforts in innovation through the regional platform to advance the manufacturing of vaccines and other health technologies, increasing regional capacity and supporting the generation of enabling ecosystems. It coordinates actions of the Regional Platform to Increase Manufacturing Capacity of vaccines and other health technologies and supports the Regional Revolving Funds in the selection and continuous assessment of quality products for priority public health programs in the Americas.

DESCRIPTION OF DUTIES

Under the general supervision of the Director, Innovation, Access to Medicines and Health Technologies (IMT) and the direct supervision of the Unit Chief, Quality and Regulation of Medicines and Health Technologies (IMT/QR) the incumbent is responsible for, but not necessarily limited to, the following assigned duties:

a) Provide technical, strategic advice and collaborate in the development of objectives, strategies, policies, norms, guidelines, procedures and evaluation processes for the Organization's technical cooperation programs on regulation, quality control and quality assurance of vaccines and biotechnological products in the Region;

b) Provide expert regulatory guidance on vaccine and biotechnological product development, ensuring compliance with global standards (WHO/PAHO) across manufacturing, quality, safety, efficacy and quality assurance. This includes supporting procurement through organizational channels, such as PAHO’s Regional Revolving Funds, facilitating WHO pre-qualification processes and enhancing regional regulatory frameworks and production capacities to ensure harmonized and effective regulation;

c) Provide authoritative technical advice on policies, norms, guidelines, procedures and evaluation that help advance IMT in the areas of regulatory oversight of essential biotechnological products in the Region, with special focus to increase access to biosimilars;

d) Contribute as the Organization’s Secretariat of Pan American Network for the Drug Regulatory Harmonization (PANDRH) to provide technical support to National Regulatory Authorities (NRA) on vaccines and biotechnological products regulation to strengthen their regulatory capacities, and to promote best practices;

e) Promote the establishment of Regional networks/initiatives aimed at improving vigilance and control activities of vaccine and biotechnological products;

f) Provide technical support for the development of training content and materials for strengthening capacities of Member States in the area of regulatory aspects and quality assurance of vaccines and biotechnological products;

g) Collaborate and promote activities aimed at the development of vaccines required for the Region, through concerted action among biological laboratories and research institutions existing in the countries and outside the Region, adopting a global approach which encompasses regulatory and quality control activities, including but not limited to secure facilities for the internal and external control of vaccines and biologicals at international reference laboratories;

h) Collaborate with other projects to increase access to vaccines and biologics, within or outside the Entity to achieve effective coordination of program activities and appropriate utilization of resources;

i) Mobilize national and international resources to support the implementation of programs under areas of responsibility;

j) Contribute to the preparation of biennial programs and budgets (BWP), semiannual work plans and periodic evaluations for assigned projects; participate in the annual performance evaluation of the Entity;

k) When called upon to directly supervise staff, establish clear work objectives, conduct timely and effective performance appraisals, provide coaching and feedback, and support staff development opportunities;

l) Perform other related duties, as assigned.

REQUIRED QUALIFICATIONS

Education:

Essential: A university degree in one of the health and/or biological sciences, and a master’s degree in biological sciences or laboratory sciences oriented to biological products or any other field related to the functions of the post from a recognized institution.

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.PAHO, only considers official degrees 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/. PAHO will also use the databases of the Council for Higher Education Accreditation http://www.chea.org and College Navigator, found on the website of the National Centre for Educational Statistics, https://nces.ed.gov/collegenavigator to support the validation process.

Experience:

Essential: Nine years of combined national and international experience in planning, organization, management and/or evaluation of regulation and quality assurance systems for vaccines and biotechnological products.

Desirable: At least three years of technical experience working in cooperation programs and/or activities concerning regulatory oversight of vaccines and/or biotechnological products within the Region of the Americas, or with developing countries will be an asset. Demonstrated experience on regional and global tools for assessing regulatory capacities, and harmonization and convergence initiatives will also be an asset.

SKILLS:

PAHO Competencies:

Overall attitude at work: Maintains integrity and takes a clear ethical approach and stance; demonstrates commitment to the Organization’s mandate and promotes the values of the Organization in daily work and behavior; is accountable for work carried out in line with own role and responsibilities; is respectful towards, and trusted by, colleagues and counterparts.

Respecting and promoting individual and cultural differences: Relate well to diversity in others and capitalize on such diversity - Relates well to diversity in others and capitalizes on such diversity. Treats all people with dignity and respect. Relates well to people with different cultures, gender, orientations, backgrounds and/or positions; examines own behavior to avoid stereotypical responses; considers issues from the perspective of others and values their diversity.

Teamwork: Collaborate and cooperate with others - Works collaboratively with team members and counterparts to achieve and build rapport; helps others when asked; accepts joint responsibility for the team’s successes and shortcomings.

Communication: Write effectively/Share knowledge - Writes down ideas in a clear, structured, logical and credible way; drafts and supports the development of guidelines, policies and procedures. Shares relevant information openly and ensures that the shared information is understood; considers knowledge sharing as a constructive working method and demonstrates awareness of the Organization.

Producing Results: Work efficiently and independently/Deliver quality results - Monitors own and others’ work in a systematic and effective way, ensuring required resources and outputs. Aligns projects with Organization’s mission and objectives. Consistently solves own and team’s problems effectively as needed. Proactively engages in projects and initiatives, accepting demanding goals, in line with Organizational Strategies and Program of Work. Demonstrates accountability for work of team and sets an example, while explicitly articulating lessons learnt for own and team’s benefit.

Ensuring effective use of resources: Strategize and set clear objectives/Monitor progress and use resources well - Sets specific, measurable, attainable, realistic and timely objectives for own team and/or the Organization; systematically analyses and anticipates priority projects for own team and allocates necessary resources to achieve them; identifies the cross-Organizational resources needed for large- scale projects in line with key Organizational objectives. Anticipates foreseeable changes and adapts own and team’s projects in the face of unforeseen circumstances and/ or challenges; creates measures and criteria to monitor progress of overall projects against key Organizational objectives; creates cost-effective solutions for the Organization.

Building and promoting partnerships across the Organization and beyond: Develop networks and partnerships and encourage collaboration - Builds and negotiates strategic partnerships and alliances with a wide range of key stakeholders to ensure Organizational results and success. Creates innovative opportunities for promoting synergies inside and outside the Organization to improve Organizational success.

Technical Expertise:

-Expert knowledge and skills in the areas of organization, management (including planning, financing, organization, staffing, directing and controlling) of all phases of research, development, production, regulation and quality control of vaccines and biologicals.

-Strong knowledge and skills in project planning, management and evaluation, including resource mobilization and grant management.

-Knowledge and skills in the formulation of technical cooperation interventions and in the development of criteria and instruments for evaluating program interventions.

-Strong public health and strategic thinking background showing resourcefulness, initiative, leadership qualities, skills to deals with difficult situations and sensitive areas; demonstrated ability to identify, assess, analyze, synthesize and provide recommendations on key political and technical issues.

-Strong interpersonal skills, diplomacy and tact to effectively communicate with senior level officials, multiple stakeholders and professionals from diverse cultural and professional backgrounds.

-Strong professional oral and writing skills, including the development of reports, oral presentations, and technical/persuasive documents for consideration at the highest levels of the Organization.

Languages:

Very good knowledge of English or Spanish with working knowledge of the other language. Knowledge of French and/or Portuguese would be an asset.

IT Skills:

Demonstrated ability to effectively use current technology and software, spreadsheets and presentations, as well as Enterprise Resource Planning (ERP) and management information systems. Other IT skills and knowledge of software programs such as Microsoft Excel, Outlook, OneDrive, PowerPoint, Teams, SharePoint, and Word are considered essential.

REMUNERATION

Annual Salary: (Net of taxes)

USD $77,326.00 post adjustment

Post Adjustment:70.2% of the above figure(s).This percentage is to be considered as indicative since variations may occur each month either upwards or downwards due to currency exchange rate fluctuations or inflation.

ADDITIONAL INFORMATION

This vacancy notice may be used to fill other similar positions at the same grade level.

Any appointment/extension of appointment is subject to PAHO Staff Regulations, Staff Rules and e-Manual.

For information on PAHO please visit: http://www.paho.org

PAHO/WHO is an ethical organization that maintains high standards of integrity and accountability. People joining PAHO are required to maintain these standards both in their professional work and personal activities.

PAHO/WHO also promotes a work environment that is free from harassment, sexual harassment, discrimination, and other types of abusive behavior. PAHO conducts background checks and will not hire anyone who has a substantiated history of abusive conduct.

PAHO/WHO personnel interact frequently with people in the communities we serve. To protect these people, PAHO has zero tolerance for sexual exploitation and abuse. People who commit serious wrongdoing will be terminated and may also face criminal prosecution.

PAHO/WHO is committed to workforce diversity. PAHO/WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.

PAHO/WHO offers an attractive compensation package including an annual net salary and post adjustment, which reflects the cost of living in a particular duty station and exchange rates (subject to mandatory deductions for pension contributions and health insurance).Other benefits include: 30 days annual leave, dependency benefits, pension plan and health insurance scheme. Benefits for internationally recruited staff may include home leave, travel and removal expenses on appointment and separation, education grant for dependent children, assignment grant and rental subsidy.

Candidates appointed to an international post with PAHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.

All applicants are required to complete an on-line profile to be considered for this post.

Candidates will be contacted only if they are under serious consideration. A written test and/or interview will be held for this post.The post description is the official documentation for organization purposes.