Senior Technical Advisor - RSS

Senior Technical Advisor - RSS

Funded by the US Agency for International Development (USAID), the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program provides pharmaceutical system strengthening assistance for sustained improvements in health system performance and to advance USAID’s goals of preventing child and maternal deaths, controlling the HIV/AIDS epidemic, and combatting infectious disease threats, as well as expanding essential health coverage.  The goal of the global, five-year (2018–2023) program is to enable 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 medicine-related pharmaceutical services.    

Overview

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.

Specific Responsibilities

Technical Support (40%)

• 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.

Coordination (20%)

• 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 (20%)

• 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.

Monitoring and Evaluation (20%)

• Contribute to the development of MTaPS Nepal Performance Monitoring plan (PMP), and support the collection and validation of relevant data to report project indicators.
• Contribute to the adequate documentation and dissemination of program results and lessons learned, including the development and submission of project’s mandatory reports, technical documents and reports; and abstracts and articles for scientific journals and conferences.

Qualifications and Experience

Education:

Required:

• 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.

Preferred:

• Master’s Degree in a health related field

Experience:

Required:

• 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.

Preferred:

• 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.

Competencies:

• 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.

Physical Demands:

• 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.

Background Information

Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health. Since its founding in 1971, MSH has worked in over 150 countries with policy makers, health professionals, and health care consumers to improve the quality, availability and affordability of health services. Working with governments, donors, non governmental organizations, the private sector, and health agencies, MSH responds to priority health problems such as HIV & AIDS; tuberculosis; malaria; maternal, newborn and child health; family planning and reproductive health; and chronic non-communicable diseases such as cancer, diabetes, and lung and heart disease. Through strengthening capacity, investing in health systems innovation, building the evidence base, and advocating for sound public health policy, MSH is committed to making a lasting difference in global health.

EEO Statement

Management Sciences for Health is an equal opportunity employer offering employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, citizenship, physical or mental disability, or veteran status.

Reports To

Country Program Director

Please submit CVs and applications in English.

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