Senior Technical Advisor – RSS
MAIN PURPOSE OF JOB
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 medical products regulatory processes (activities) including product registration, inspection of pharmacies and distributors of medical products, pharmacovigilance, and post-marketing surveillance.
MAIN DUTIES AND RESPONSIBILITIES
Technical Support 40%
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 medical products 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 of establishments, regulatory inspections, 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 its four year strategic plan.
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 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 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 pharmaceutical companies.
Carry out additional responsibilities as may be assigned from time to time.
Monitoring & Evaluation 20%
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; success stories, and abstracts and articles for scientific journals and conferences.
Master’s Degree in pharmacy or public health with other relevant pharmaceutical discipline and hands-on experience in public health programs especially related to medical products regulation.
Master’s Degree in a health-related field
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 regulatory inspection, and pharmacovigilance in low- and middle-income countries desired.
Knowledge of international regulatory guidelines including pharmacovigilance guidelines (e.g., WHO, ICH, PIC/S, EMA, FDA, GHTF, ISO, etc.)
Demonstrated experience in developing and implementing regulatory (including 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.
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., ETC.
MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran, and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.
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