Senior Technical Advisor - Policy Strategy and Engagement (PSE)

Position: Senior Technical Advisor - Policy Strategy and Engagement (PSE)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.

USP is seeking for a Senior Technical Advisor - Policy Strategy and Engagement (PSE) in support of PQM+ program implementation in Nepal.

Summary of the Position

Under the direct supervision of Deputy Chief of Party, The Senior Technical Advisor Policy, Strategy and Engagement (STA-PSE) will lead and manage PQM+ program interventions to, a) strengthen health products regulation policies and procedure; b) design strategies, business plans to optimize local production and facilitate  mobilization of resources for sustainability/resilience; c) and Institutionalization of quality assurance best practices in supply chain of health product to mitigate the risks of substandard and falsified health products. 

The STA-PSE will collaborate with National Medicines Regulatory Authorities (NMRA) i.e., Department of Drug Administration (DDA), National Medicine Laboratory (NML), National Programs, Logistics Management section, relevant departments of Ministry of Health and Population (MoHP) Ministry of Industries Commerce & Supplies (MOICS), National Planning Commission and other public/private sector stakeholders to ensure the timely and quality implementation of PQM+ program supported interventions at national and sub national Levels.  

Roles and Responsibilities

• Technical Leadership 
  • Provide technical leadership to strengthen Regulatory functions, quality assurance and control systems at the Department of Drug Administration, National Medicine Laboratory, local medicine manufacturers (both public and private allopathic manufacturers) and help build awareness of the threat of SF medical products.
• Project and Team Management: 
  • Support team member to develop project implementation plan and support during actual implementation through coordination and collaboration
  • Build and strengthen team to align with project goal/objectives and manage team to plan and implement activities
• Implementation plan: 
  • Coordinate and support in drafting pharmaceutical manufacturing strategies and national medicine policy of Nepal. 
  • Lead drafting Post Marketing Surveillance Regulations for Nepal and advocate for institutionalization. 
  • Lead drafting National Guidelines on Safe disposal of unwanted pharmaceuticals
  • Advocacy to institutionalize codes and regulations related to National Medicinal Regulatory Authority.
  • Technical lead in drafting and developing National Medicine Laboratory Regulations to National Medicine Laboratory of Nepal.
  • Coordinate and support in drafting NML’s five year strategic costed plan (2023-2028)
  • Support in organizing a multistakeholder advocacy meeting to address pharmaceutical sector related issues.
  • Support developing a course on Substandard and Falsified (SF) medicines and institutionalize it to the council.
  • Technical Support in awareness raising program on SF medicines and support to conduct LMG activities at the local governance unit level to reduce the prevalence of SF medicines and assuring quality of medicine in supply chain management
• Monitoring and Control: 
  • Support in implementing all activities including monitoring quality process and deliverables of relevant project objectives.

Basic Qualifications

• Master’s degree in pharmacy, chemistry, microbiology, or related field; a higher degree will be an advantage.
• At least 10 years of experience in pharmaceutical and public health sector with at least five years focused experience on policy and regulations related to national regulatory authority in Nepal.
• Experience on coordination, collaboration and organizing meeting with high-level government officials including drafting of documents on pharmaceutical policy, strategies and regulations.
• Knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), and good laboratory practices (GLP) norms in related fields.
• In depth knowledge about international best practices in pharmaceutical sector.

Preferred Qualifications

• Experience in managing virtual teams based in low- and middle-income countries.
• Expertise in health systems strengthening.
• Pharmacist, Physician, or other health profession qualification highly desirable
• Proof of experience leading effective, timely, and quality implementation of donor-funded (particularly USAID-funded) global health or international development projects
• Good understanding of and experience working with USAID compliance rules and regulations
• Significant experience working with high level officials in USAID and country governments
• Strong people management skills, including of virtual, matrixed teams
• Excellent client relationship management skills 
• Excellent written and verbal communication skills
• Ability to work in cross-cultural settings. 
• Ability to demonstrate highest degree of ethics and integrity.  

Application Process:

Interested candidates should submit cover letter and CV by email to GPHNepalRecruitment@USP.org clearly stating Senior Technical Advisor - Policy Strategy and Engagement (PSE) in the subject line of the e-mail.

Application Deadline: September 4, 2022