Develop sound technical cooperation programs that develop and strengthen primary health care based health systems, health policies, health services and programs, technologies and medicines, health investment and financing, health research and development of human resources for health. Support country and territory capacities, facilitate inter-country networks and cooperation, and implement and evaluate inter-sectorial approaches.
Post: Specialist, Regulatory Affairs, Medicines & Health Technologies
Vacancy Notice No: PAHO/11/TA77
Contract type: Temporary appointment
Duration of contract: Temporary appointment, one year. Firs year probationary period.
Description of duties:
Under the general supervision of the Manager, Health Systems based on Primary Health Care (HSS), and the direct supervision of the Senior Advisor, Medicines and Health Technologies (HSS/MT) the incumbent is responsible for, but not necessarily limited to, the following assigned duties:
a) Provide technical support and advice on regulation of medicines and health technologies, development of national and regional regulatory sector profiles including key descriptors and indicators, focusing on the general regulatory landscape for medicines and health technologies, legal framework, and specific areas of work relating to core regulatory functions.
b) Revise regulatory terminology in use throughout the Region; develop a glossary of terms based on the Organization's norms and guidelines.
c) Develop and revise data collection tools to evaluate regulatory structures, process and outcomes.
d) Support the collection of information on regulatory processes and systems within the Member States
e) Revise data collected for completeness and accuracy to ensure quality; coordinate with national regulatory authorities and Country Offices on issues relating to the quality of data being provided.
f) Provide technical support to other professionals in the quality and regulation of medicines and health technologies, and specifically in the development of a regional virtual platform on regulatory processes and systems.
g) Develop and support the implementation of communication mechanisms with national regulatory authorities including list serves, communities of practices and other virtual forums to strengthen exchange of information and knowledge transfer between national regulatory authorities.
h) Support the preparation of proposals and reports relating to strengthening national regulatory capacity.
i) Provide technical support to working groups of the Pan American Network for Drug Regulatory Harmonization, as required.
j) Perform other related tasks assigned.
Essential: A university degree in pharmaceutical science or related field from an accredited university.
Desirable: A master's degree in biology or related field, in areas of/or associated with medicine quality assurance, pharmaceutical quality management system or regulatory affairs would be an asset.
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Key Behavioral Competencies
Intra-institutional Action: Operates in a fair, consistent and equitable manner, and displays such behavior by example. Ensures that the mission and the values of the Organization as well as the setting in which projects will be carried out are the drivers in one's technical work. Understands the results required and performs to that standard. Behaves consistently in accordance with the Code of Ethics of the Organization.
Communication: Actively engages in conversation with the key players in a multicultural environment both within and outside the organization. Develops a network of appropriate contacts inside and outside PAHO to gain information or to build an alliance. Takes into consideration the multicultural differences within the organization.
Teamwork: Promotes team work and leads one's area to finish tasks and accept responsibility. Creates a positive environment within the area of work. Makes everyone feel like they are part of the team as well as welcomes and appreciates everyone's ideas and suggestions. Able to see the positive aspects of working as a team, shares the team's enthusiasm for achieving mutual goals.
Analysis, Synthesis and Forecasting: Takes or organizes individual and collective action after analyzing situations on the basis of the available evidence and knowledge. Continuously analyzes the evolution of situations in an area of work and makes suggestions to adjust or confirm the decisions necessary to implement required actions. Is capable of anticipating the implications of an analyzed situation between six months to one year ahead.
Knowledge Management: Shares knowledge and information appropriately and participates in activities to facilitate sharing. Develops tools and protocols for creation, integration and dissemination of knowledge. Researches opportunities, methods and approaches for delivering value through improved knowledge.
External Action: Promotes the values of the Organization through mutually relationships with external institutions. Monitors one's work using transparency in the execution of all tasks.
Accountability: Identifies, in conjunction with management, specific activities, processes jobs that require defined accountability, linking them to accountability strategies and objectives. Revises periodically progress made in the established work plan with his/her supervisor. Constantly reaches their objectives.
- Strong knowledge of pharmaceutical quality and regulatory issues and international standards in regulation of medicines and health technologies.
- Knowledge of regulatory structures processes and core functions.
- Ability to manage, assess and review large volumes of data; management of information technologies to facilitate the presentation and analysis of data to guide the technical cooperation programs.
- 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.
Demonstrated ability to effectively use a computer and utilize software programs such as Microsoft Office Word, Excel, PowerPoint and Outlook. Other IT skills and knowledge
Essential: Seven years of combined national and international experience in pharmaceutical regulatory systems and/or prequalification of pharmaceutical manufacturers including technical cooperation to countries to strengthen capacity in evaluation and monitoring of pharmaceutical quality systems.
Desirable: Experience in international technical cooperation to strengthen capacity in evaluation and monitoring of pharmaceutical would be an asset.
Very good knowledge of English or Spanish with working knowledge of the other language. Knowledge of French and/or Portuguese would be an asset.
A WRITTEN TEST AND/OR INTERVIEW MAY BE HELD FOR THIS POST. APPLICANTS WILL BE CONTACTED ONLY IF THEY ARE UNDER SERIOUS CONSIDERATION. APPLICANTS ARE REQUIRED TO COMPLETE AN ON-LINE PERSONAL HISTORY FORM. THE POST DESCRIPTION IS THE OFFICIAL DOCUMENT FOR ORGANIZATIONAL PURPOSES.
Annual salary: (Net of tax)
$56,018.00 at single rate
Date: 2 June 2011
Application Deadline: 30 June 2011
Duty Station: Washington, D.C., United States of America
Organization unit: AM Americas (AM)
Medicines and Health Technologies / Health Systems based on Primary Health Care (HSS/MT)
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