Technical Advisor - Policy Strategy & Engagement (PSE)

Position: Technical Advisor - Policy Strategy & 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 Technical Advisor - Policy Strategy & Engagement (PSE) in support of PQM+ program implementation in Nepal.

Summary of the Position

Under the direct supervision of the Senior Technical Advisor (STA), the Technical Advisor will technically support PQM+ Nepal team in coordination with the chief of party, deputy chief of party, other technical advisors and in collaboration with the Department of Drug Administration, National Medicine Laboratory, Public and Private Manufacturers and other relevant stakeholders to improve the efficiency. 

The TA PSE will manage PQM+ program interventions to strengthen health products regulation policies and procedure and also design strategies, business plans to optimize local production and facilitate mobilization of resources for sustainability/resilience national regulatory authority in Nepal.

Roles and Responsibilities

• Technical Leadership 
  • Support STA in providing 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).
• 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: 
  • Coordination and drafting of pharmaceutical manufacturing strategies and national medicine policy of Nepal. 
  • Draft Post Marketing Surveillance Regulations for Nepal and advocate for institutionalization. 
  • Draft National Guidelines on Safe disposal of unwanted pharmaceuticals
  • Support in advocating to institutionalize codes and regulations related to National Medicinal Regulatory Authority.
  • Draft National Medicine Laboratory Regulations of NML.
  • 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.
• 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 5 years of experience in regulatory system strengthening program including quality policy and strategy development control in LMICs.
• Experience on drafting 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 managing 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 Technical Advisor - Policy Strategy & Engagement (PSE) in the subject line of the e-mail.

Application Deadline: September 4, 2022