Vacancies at U.S. Pharmacopeial Convention (USP)

Project Leadership (25%)

• Accountable for high-quality implementation of USP’s interventions on the KIPS project. to ensure USP-led activities are progressing appropriately (e.g., technical quality, timely implementation, performance against indicator targets, application of project learning, staffing, budget spending, and risks and issues).
• Provide overall strategic guidance and oversight on USP’s specific areas of implementation and cross-cutting input.
• Build and maintain strong relationships with stakeholders involved in pharmaceutical management in Kenya.
• Lead, supervise and mentor a team of pharmaceutical management professionals and foster a collaborative and high-team performance culture.

Technical Implementation (75%)

• Lead on implementing interventions related to pharmaceutical management, including but not limited to product selection and prioritization, resource optimization, pharmaceutical services, pharmacovigilance and patient safety, regulatory system strengthening, track and trace/digital serialization and antimicrobial resistance.
• Provide direct technical assistance to government counterparts as necessary, to enhance their capacity to perform their oversight and stewardship role in the pharmaceutical management areas listed above and sustainably move toward technical independence
• Optimize processes and resources to improve efficiency in implementing identified interventions including ensuring continuous engagement of country counterparts in implementing interventions and integrating the technical delivery of pharmaceutical management activities
• Support the integration of pharmaceutical management interventions with the pharmaceutical supply chain needs of the country as appropriate
• Maintain high-quality standards in the implementation of pharmaceutical management interventions in collaboration with other project staff, government and private sector counterparts including identifying and mitigating risks that may affect KIPS ability to implement high quality and timely interventions
• Drive the integration of innovative thinking in the delivery of pharmaceutical management interventions
• Develop and deliver training programs to enhance pharmaceutical management
• Perform any additional pharmaceutical management activities as may be required by the donor, USP or DAI to support successful project implementation.

Who is USP Looking For?

• The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Master’s degree or equivalent in Regulatory Science, Pharmacy, Pharmaceutical Science, Public/Global Health, Medicine, Chemistry, Biology, pharmacovigilance, Epidemiology or related fields
• Minimum of 10 years of professional experience in pharmaceutical management, with at least 5 years in a leadership role and proficiency in one or more of the following pharmaceutical management areas: product selection and prioritization, pharmaceutical policies and regulation, supply chain management, or strengthening national or regional regulatory authorities.
• Good understanding of the pharmaceutical and supply chain sector and working knowledge of national medicine regulation.
• Experience working and currently residing in Kenya is required
• Experience designing plans for product track and trace/serialization adoption and deployment, particularly in the LMIC context is an added advantage.
• Experience in training, and mentoring government and private sector stakeholders
• Extensive experience in developing and implementing donor funded programs
• Ability to travel locally.
• Excellent written and oral communication skills with ability to produce quality, coherent and informative reports.
• Ability to work in a fast-paced environment, quickly adapt to changes and respond to donor demands in a timely manner is required.
• Fluency in English is required

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Technical Implementation:

• Provide technical leadership to develop and implement interventions necessary to strengthen the regulatory system of Kenya to attain a higher WHO GBT maturity level including but not limited to the areas of marketing authorization, regulatory inspections, licensing of establishments, vigilance, market surveillance and control including risk-based post marketing surveillance, and Antimicrobial stewardship (AMS), etc.
• Work with the Pharmaceutical Management Director and other project staff to optimize processes and resources to improve efficiency in implementing identified RSS interventions.
• Maintain high-quality standards in the implementation of RSS interventions in collaboration with government, private sector counterparts and other project staff.
• Identify and mitigate risks that may affect KIPS’ ability to deliver high quality and timely RSS interventions, and escalate to the Pharmaceutical Management Director.
• Drive the integration of novel thinking in the delivery of RSS interventions, aligning interventions with new thinking and best practices in the sector, making sure to link regulatory system interventions with improving the pharmaceutical supply chain.
• Provide specific technical assistance to the regional offices of PPB and relevant county entities in monitoring the quality of HPTs through post-marketing surveillance, reporting of adverse drug events, and other medicine related issues to ensure patient safety.
• Collaborate with the AMR and Rational Use Manager on designing and implementing interventions aimed at strengthening AMS and appropriate use of medicines and enhancing patient safety. 
• Support efforts to enhance regional reliance, work sharing, and other regional collaborative efforts related to RSS.
• Ensure collection of good quality data to support progress monitoring towards achieving relevant RSS and AMS indicators.
• Develop and deliver training programs to enhance RSS and build government counterparts capacity to sustainably move toward technical independence.
• Build and maintain strong relationships with stakeholders involved in RSS and represent the KIPS project at RSS engagements with relevant stakeholders
• Perform any additional regulatory system strengthening activities as may be required by the donor, USP or DAI to support successful project implementation.

Who is USP Looking For?

• The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Master’s degree or equivalent in Regulatory Science, Pharmacy, Pharmaceutical Science, Public/Global Health, Medicine, Chemistry, Biology, Pharmacovigilance, or related fields
• Minimum of five years of relevant experience in medicine regulation with at least four years of experience working with or supporting a national or regional medicines regulatory authority on one or more of the key regulatory functions including pharmacovigilance and patient safety
• Demonstrated experience with the WHO global benchmarking tool is required.
• Excellent understanding of supply chain and the pharmaceutical development process from pre-clinical development through life cycle management Experience working and currently residing in Kenya is required
• Experience in training, and mentoring government and private sector stakeholders
• Ability to work in a fast-paced environment and quickly adapt to changes and respond to donor demands
• Ability to travel locally
• Excellent written and oral communication skills with ability to produce quality, coherent and informative reports
• Fluency in English is required