The goal of the global five year USAID Medicines, Technologies and Pharmaceutical Services (MTaPS) Program is to help low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services. MTaPS, implemented by Management Sciences for Health (MSH) and partners, will provide technical assistance to the Ministry of Health and Population (MOHP) and the Department of Drug Administration (DDA) including other relevant implementing agencies to strengthen pharmaceutical systems including pharmaceutical sector governance, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.
The Senior Technical Advisor – Regulatory Systems Strengthening (RSS) provides technical assistance to the DDA and MOHP including other relevant entities to build capacity and strengthen fundamental medicines regulatory processes and management systems including for development/updating of relevant policy documents, regulations, and guidelines, medicines registration, inspection of pharmacies and distributors of medicines, pharmacovigilance and post-marketing surveillance.
Technical Support (50%)
- Prepare and give technical presentations on key project activities and achievements as needed.
- In coordination with relevant partners, provide technical assistance to DDA to strengthen institutional and individual capacity, management systems, and governance of regulatory functions and activities at federal and provincial level.
- Support DDA to review and strengthen pharmaceutical regulatory systems including registration processes, structure and tools, including through continuous quality improvement approaches.
- In collaboration with other partners, support DDA to review its operational processes including regulatory aspects to improve licensing, inspection, pharmacovigilance, post-marketing surveillance, and enforcement systems and tools.
- In collaboration with relevant partners, provide technical assistance to DDA to develop long-term institutional development or strategic plan, and support development and implementation of related action plan.
- Work closely with the MTaPS Nepal Management Team and the Finance and Administration Manager to develop and monitor appropriate/adequate budgets to support relevant technical activities.
- Report regularly to the Country Program Director on progress/results achieved in technical work plans and barriers encountered, and resolve any challenges faced.
- Represent the program at various technical meetings with other cooperating agencies and participate in various working groups as required, including making technical presentations on key activities and achievements of assigned areas as needed.
- Maintain close liaison and coordination with senior officials in the MOHP and DDA and other key stakeholders e.g. WHO, USAID implementing partners, to ensure technical assistance activities are carried out with their active participation for building ownership.
- Work closely with other MTaPS team members to ensure technical work plans are being implemented in a timely and technically sound manner, and productively leverage collaboration with key government and other stakeholders and partners.
Capacity Building (30%)
Qualifications and Experience
- Contribute to the design, implementation and monitoring of capacity building activities for DDA and MOHP to be included in the MTaPS Nepal workplan.
- Work with relevant partners to build sustainable capacity to manage the pharmacovigilance program to include public and private health facilities, and also pharmaceutical companies.
- Carry out additional responsibilities as may be assigned from time to time.
- Advanced Degree in pharmacy, medicine, health management, or public health with other relevant discipline and hands on experience in public health programs especially related to medicine regulation.
- Master’s Degree in a health related field
- At least 7 years’ of relevant experience in areas of pharmaceuticals and or health technologies management, regulatory systems strengthening related projects, pharmacovigilance, preferably with international donors and organizations such as USAID, Global Fund, UN agencies-WHO and World Bank.
- Demonstrated experience in regulatory affairs specifically medicines registration, inspection, and pharmacovigilance in low- and middle-income countries desired.
- Knowledge of international regulatory and pharmacovigilance guidelines (e.g., WHO, ICH, PIC/S, EMA, FDA, GHTF, ISO, etc.)
- Demonstrated experience in developing and implementing regulatory and/or pharmacovigilance systems strengthening interventions obtained from working with national regulatory authority, national pharmacovigilance centers, or from the pharmaceutical industry preferred.
Knowledge and Skills:
- Strong knowledge and understanding of regulatory systems including health systems of low and middle-income countries preferably Nepal and other south Asian countries
- Strong organizational skills and ability to work in a team-oriented, culturally diverse environment.
- Excellent interpersonal skills, sound judgment, communication skills, training experience, ability to identify and resolve policy and operational constraints.
- Experience and ability working with senior government officials.
- Experience with USAID and other donor agencies desirable.
- Excellent written and verbal communication and presentation skills in English.
- Demonstrated intermediate skills in Microsoft Office Suite applications, including Word, Excel, and PowerPoint. Familiarity with Microsoft Project a plus.
- English fluency required including speaking, writing, and reading; additional proficiency in Nepali or other Nepalese language a plus.
- Functional competencies: Highly motivated, resourceful, results driven and persistent. Ability to think strategically, gather and analyze information in order to make appropriate decisions. Strong interpersonal and communication skills.
- Core MSH competencies: adaptability, communication, problem solving, creativity and innovation, timeliness of work, quality of work and team relationships, resource utilization.
- Sound judgment, self-motivated, strong initiative.
- Ability to travel in-country to support technical activities.
- Willingness and ability to travel internationally, including to the US as needed.
- Keyboard use, pulling drawers, lifting papers <10lbs.
About the Organization
Management Sciences for Health, an international nonprofit organization, is dedicated to closing the gap between what is known and what is done about public health problems. MSH saves lives and improves health by helping public and private organizations throughout the world to effectively manage people, medicines, money, and information. Working from more than 30 country offices and our US headquarters, our staff from 65 nations is highly regarded for its technical expertise, integrity, and commitment to making a lasting difference in health.
Management Sciences for Health (MSH) is a nonprofit international health organization composed of more than 2,000 people from 73 nations. Their mission is to save lives and improve the health of the world’s poorest and most vulnerable people by closing the gap between knowledge and action in public health. Together with their partners, they are helping managers and leaders in developing countries to create stronger management systems that improve health services for the greatest health impact.
MSH takes an integrated approach to building high-impact sustainable programs that address critical challenges in leadership, health systems management, human resources, and medicines. Simply put, they support stronger health systems for greater health impact.
Their expertise in these areas falls into the broad categories of management functions—for example, leadership and governance or pharmaceutical management—and health areas like tuberculosis or maternal, newborn, and child health. They apply their expertise by
- Partnering with governments, local organizations, and communities in developing nations to build their own capacity for long-term health impact;
- Providing global leadership in critical areas of health management and health care delivery;
- Bringing the best of MSH from around the globe to the people we serve, working as One MSH with a focus on lasting health system improvements.
Leadership, Governance, & Management
They work with in-country partners to build stronger health systems to improve:
- the management and leadership of priority health programs, health organizations, and multisectoral partnerships such as The Global Fund to Fight AIDS, Tuberculosis and Malaria, developing a critical mass of managers at all levels of the health system who can lead and inspire teams to achieve results;
- the management systems of health organizations in the public and private sector, transferring practical approaches and skills to ensure that management structures contribute to sustainable organizational success;
- the governance and management of health organizations and multisectoral partnerships, facilitating change and transferring knowledge to enable organizations to administer their resources efficiently and scale up their services.
Health Service Delivery
MSH combines extensive public health expertise, proven service delivery approaches, and evidence-based interventions in five critical areas:
- HIV & AIDS
- Maternal, newborn, and child health
- Family planning and reproductive health
- Other communicable diseases, including malaria and pandemic and avian influenza
Human Resources for Health
MSH helps governments develop multisectoral strategies and policies to plan and manage their health workforces. We use a comprehensive approach that addresses all the facets of human resources for health needed to achieve an adequate supply of well-trained and motivated health workers. MSH offers capabilities in leadership, human resource management, education, partnerships, policy, and finance to achieve these goals.
Vital to our success is a participatory approach to project design and implementation, which cultivates broad-based support from all stakeholders. We also build and improve infrastructure and local capacity to effectively purchase, store, deliver, and use quality essential medicines.
Health Care Financing
MSH helps governments and NGOs assess their current financial situation and systems, understand service costs, and develop initiatives to use existing funds more effectively and generate additional revenue—all with the goal of supporting a nation’s health priorities.
MSH has developed proven methods for rapidly strengthening the analysis and use of existing health data—normally at the province, district, and facility levels—without revising existing recording and reporting requirements. With an emphasis on learning through action, district teams undertake assessments of health services, identify gaps in performance, and design solutions to support better decision-making and, therefore, better management of improved services.
MSH has worked closely with the Health Metrics Network of the WHO to develop a comprehensive approach for enhancing the performance of health information systems and data by employing a practical, strategic planning process that can be carried out by national working groups.