Senior Technical Advisor – RSS

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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 policymakers, 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.

JOB DESCRIPTION

 

JOB TITLE

 

 

Senior Technical Advisor – RSS

 

GRADE/BAND

 

 

J

 

MAIN PURPOSE OF JOB

 

Overall Responsibilities:

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 Rwanda Food and Drugs Authority (Rwanda FDA) and other Ministry of Health departments such as the Rwanda Biomedical Center, the National Tuberculosis (TB) Program (NTP), HIV/AIDS Program and maternal, neonatal and child health (MNCH) program to improve the availability and use of essential pharmaceuticals through stronger pharmaceutical regulatory systems.

 

The Senior Technical Advisor – Regulatory Systems Strengthening (RSS) provides technical assistance to the Rwanda FDA and Ministry of Health to build capacity and strengthen fundamental medicines regulatory processes (activities) including medicines registration, inspection of pharmacies and distributors of medicines, pharmacovigilance and post-marketing surveillance.

 

DEPARTMENT

 

 

Medicines, Technologies and Pharmaceutical Services (MTaPS) Program

 

LOCATION

 

 

Kigali, Rwanda

 

REQUIRED MINIMUM EDUCATION

 

Required:

Master’s Degree in pharmacy 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

 

REQUIRED MINIMUM EXPEREINCE

 

  •  
  • At least 7 years’ of relevant experience in areas of pharmaceuticals and 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 required, and additionally 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 of low and middle-income countries preferably Rwanda and other African 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 French and/or Rwandese language a plus.

 

COMPETENCIES

 

CORE JOB 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

Travel requirements:

  • 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., ETC.

ORGANISATION STRUCTURE

Country Program Director------STA-RSS

MAIN DUTIES AND RESPONSIBILITIES

 

Number

 

Key Performance Areas

 

Major Activities / Responsibilities

Percent of Time

(must equal 100%)

1.

 

 

 

Technical Support

  • Prepare and give technical presentations on key project activities and achievements as needed.
  • Work with Senior Technical Advisor – Pharmaceutical Services and team to develop technical documents required for strengthening medicines regulatory systems at Rwanda FDA. Organize and facilitate training for the Rwanda FDA staff as part of the capacity building process.
  • In coordination with relevant partners, provide technical assistance to Rwanda FDA to strengthen institutional and individual capacity, management systems, and governance of regulatory functions and activities.
  • Support Rwanda FDA to review and strengthen pharmaceutical registration processes, systems, and tools, including through continuous quality improvement approaches.
  • In collaboration with other partners, support Rwanda FDA 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 Rwanda FDA for effective implementation of action plan based on five years strategic plan.

 

40%

2.

Coordination

  • Work closely with the MTaPS Rwanda 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 MOH and Rwanda FDA and other key stakeholders e.g. WHO, USAID PSM project, to ensure technical assistance activities are carried out with their active participation for building ownership.
  • Work closely with the Country Program Director and other 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.

20%

 

Capacity Building

  • Contribute to the design, implementation and monitoring of capacity building activities for Rwanda FDA and MOH included in the MTaPS Rwanda work plan.
  • Work with Senior Technical Advisor – Pharmaceutical Services and other team members to build sustainable capacity to manage the pharmacovigilance program, including scaling-up pharmacovigilance reporting country wide to include public and private health facilities, and also pharmaceutical companies.
  • Carry out additional responsibilities as may be assigned from time to time.

20%

 

Monitoring & Evaluation

  • Contribute to the development of country project M&E plan, 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.

20%