Quality of Medical Products
The University of North Carolina at Chapel Hill’s UNC Eshelman School of Pharmacy and the U.S. Pharmacopeial Convention (USP) Quality Institute have partnered to establish a fellowship program for early career scientists and researchers who wish to contribute to the evidence base for quality medical products. This Request for Applications (RFA) seeks qualified candidates with advanced degrees who wish to conduct novel research and receive specialized training in quality of medical products.
The Fellowship in Quality of Medical Products will foster the research, scholarship, and careers of individuals who are poised to work with academia, government, and industry to advance knowledge about the impact of quality of medical products. Fellows will have the unique opportunity to engage in real-world training experiences, as well as interactions with USP and other stakeholders.
The USP Quality Institute defines medicine quality as a balanced, risk-based set of pre-specified characteristics, systems, and requirements that consistently ensure a medicine’s delivery of stated and implied clinical outcomes for patients. This definition encompasses all aspects of a medical product’s lifecycle, including design, manufacture, supply chain, storage and distribution, and falsification. Excluded from this definition is the quality or appropriateness of treatment guidelines and practices.
Product quality can be designed into, improved, and reinforced all along the medicine continuum, from initial drug research all the way through to the dispensing of the medicines. These interventions differ for different products, product classes, and geographies, and have varying costs, feasibility, and outcomes. Assessing which interventions are most actionable and potentially effective is of critical importance to promote judicious policies and investment aimed at promoting medicine quality. USP has strong, trust-based relationships with quality professionals and healthcare policy makers globally, as well as several well-established offices and training centers in regions throughout the world. These strengthen USP’s understanding of local priorities and specificities, as well as its ability to effectively disseminate robust evidence and recommendations.
Fellows will be expected to conduct one or more mentored research projects that address important evidentiary gaps in demonstrating the value of improving medicine quality related to the issues of cost, pricing, and procuring for quality. Projects could be either global in scope targeting challenges across low- and middle-income countries (including examining variations across or within countries), or focus on the Unites States context. Examples of such evidence gaps may be:
- Costs to stakeholders from having substandard and falsified medicines on the market
- Impact of donor transitions on procurement and medicine quality
- Benefits and costs of prequalification for manufacturers in ensuring medicine quality
- Optimal cost/pricing of medicines to maximize the value of quality medicines.
- Role of online pharmacies and impact on the prevalence of substandard and falsified medicines in the market within specific country contexts
Fellows will analyze data and report findings in peer-reviewed publications and to the broader scientific community. Data may be accessed from public sources or newly generated. In addition, USP resources referenced above can be made available to fellows in support of their research projects.
The Fellowship will provide a mentored research opportunity that includes co-mentors from UNC Eshelman School of Pharmacy and partner healthcare organizations, experts at USP engaged in research related to quality in medicines, and USP Quality Institute Advisory Group or Steering Committee members. Working under the direction of co-mentors, the awarded fellow(s) will refine their research proposal, including plans for institutional review board and other implementation details (e.g., identifying and gathering sample data). Co-mentors will commit to the full duration of the fellowship; they will collaborate in the supervision and guidance of each fellow’s research project as well as meaningful outcomes. That is, fellows will disseminate research methods and/or findings through high-impact peer-reviewed publications and presentations at national and international research meetings. Research projects will be refined and conducted based on mutual interests and competencies of the fellows and co-mentors.
The fellows will work with mentors to advance medicine quality. Key activities and training outcomes include:
- Conduct one or more mentored research project on issues relevant to medicines quality
- Develop a comprehensive understanding of the value of quality medical products, its applications to public health, and key evidentiary gaps in the demonstration of that value
- Collaborate with faculty and scientists from the UNC Eshelman School of Pharmacy and USP on research initiatives
- Participate in the UNC Eshelman School of Pharmacy postdoctoral association and related scientific seminars
- Attend scientific meetings and summarize the process and outcomes of such meetings
- Present on selected medicine quality topics at meetings or in a written format
- Experience learning opportunities with USP (e.g., direct interactions with staff, giving or attending presentations, attendance at select meetings)
Ideal candidates will demonstrate a strong interest in medicine quality through their professional and educational backgrounds. Candidates must be enthusiastic, self-motivated individuals who have a deep desire to develop their careers at the intersection of academia, industry, and government.
Specifically, candidates must possess the following qualifications:
- Advanced degree in a related scientific field (e.g., MD, MPH, MS, PhD)
- Ability to write and communicate clearly and thoughtfully
- Experience and comfort working in a research setting
- Demonstrated capacity to work independently and collaboratively
Location and Duration
The fellow will work full time at the UNC Eshelman School of Pharmacy in Chapel Hill, North Carolina, USA. The fellow will be awarded an initial one-year term, with a one-year extension upon successful completion of the first year. Success will be defined by pre-specified milestones and deliverables, which the fellow will establish with co-mentors and program directors from UNC Eshelman School of Pharmacy and USPQI. The anticipated start date of the first year will be on or around September 2, 2019.
• Competitive salary (commensurate with education and experience) • Comprehensive benefits including medical, dental, vision, and others • Funds for travel to professional conferences, at the discretion of fellowship mentors • Support for research and publications costs
Application Criteria & Key Dates
June 14, 2019 – Letter of Intent (Optional)
Applicants are strongly encouraged to submit an email letter of intent (LOI), which should include the applicant’s name, highest degree and conferring institution, and contact information (i.e., email address, mailing address, and phone number), as well as a copy of the applicants resume or CV. The LOI should be sent via email to Trista Sanford with “Letter of Intent – USPQI Fellowship” as the subject line.
June 28, 2019 – Application Due
Required Application Elements
Cover Page (template sent to you upon receipt of the LOI; see above)
Curriculum Vitae (5 page maximum)
Personal Statement (500 words maximum) describing professional background, interest in medicines quality, and how the fellowship aligns with long-term career goals.
Research Proposal (5 pages maximum in Times 11pt font, excluding references) describing a research project to undertake during the fellowship (see Research section above for range of research topic examples). The proposal is intended to gauge the interests, thoughts, and competence of fellows rather than constitute a fully formed plan. Proposals should include title, objective, aim(s), methodologic and analytic approaches as well as data sources (if existing data will be utilized, source(s) should be cited). Finally, the proposal should identify possible challenges or limitations to the feasibility of the research. The proposal should identify specific, meaningful milestones that are feasible to accomplish in each year of the 2-year fellowship (see “Location and Duration” section above). The proposal should also indicate how co-mentorship might be incorporated.
Quad Chart (template sent to you upon receipt of the LOI; see above) providing a single-page overview of the proposal should be in the provided template and should include information taken directly from the research proposal.
Scientific Publications or Other Writing Samples (submit only 2 publications). Applicant should indicate authorship role in the samples provided (i.e., primary drafter or other role). Publications are intended to gauge the research and writing capability of applicants and do not necessarily need to be on the topic of medicines quality.
Letters of Recommendation. Two professional letters of recommendation are required. Submitting an Application Submit items 1-6 of the materials listed as a single PDF in the order listed above via email to Trista Sanford by June 28, 2019. The PDF filename should follow this format: Applicant Last Name. USPQI Fellowship Application.pdf. Letters of recommendation should be submitted separately to Trista Sanford via email from the authors. Reference letters must also be received by the application deadline. We will notify applicants to confirm letters have been received.
Submitting an Application
Submit items 1-6 of the materials listed as a single PDF in the order listed above via email to Trista Sanford by June 28, 2019. The PDF filename should follow this format: Applicant Last Name. USPQI Fellowship Application.pdf. Letters of recommendation should be submitted separately to Trista Sanford via email from the authors. Reference letters must also be received by the application deadline. We will notify applicants to confirm letters have been received.
This fellowship is supported by the USP Quality Institute and administered by the UNC Eshelman School of Pharmacy. The awardee will be appointed as an academic fellow to an appropriate department, depending on educational background and prior training. Upon appointment, the UNC Eshelman School of Pharmacy will require the fellow to complete annual disclosure forms listing financial and other interests that they, their spouses or minor children, or organizations in which they are involved (as a partner, employee, board member, etc.), have a financial interest that may give rise to real or apparent conflicts with the work of the fellowship.
- The UNC Eshelman School of Pharmacy is an internationally recognized leader in pharmacy practice, education, and research. We develop leaders in pharmacy education, pharmacy practice, and pharmaceutical sciences who make a difference on human health worldwide. The School offers opportunities in pharmacy and the pharmaceutical sciences that are simply not available anywhere else. The School is part of the University of North Carolina at Chapel Hill, a major research university with a large teaching hospital and schools of medicine, public health, nursing, and dentistry. The University anchors one corner of North Carolina’s famed Research Triangle Park, which hosts an abundance of pharmaceutical, biotech, and healthcare companies. This environment offers abundant opportunities for collaboration in research, education, and patient care with partners in academia, industry, and health care. The School has specialized research centers pursuing advances in drug discovery, nanotechnology in drug delivery and cancer treatment, pharmacogenomics, and medication optimization.
- The Quality Institute (QI) is an objective, independent institute based at the United States Pharmacopeial Convention (USP), a scientific non-profit organization whose mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods worldwide. QI taps into global health, policy, scientific, and technical expertise to assess the benefits, costs, and feasibility of improving medicine quality.
The University is an equal opportunity, affirmative action employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We also encourage protected veterans and individuals with disabilities to apply.
Associate Professor, Division of Practice Advancement and Clinical Education
UNC Eshelman School of Pharmacy
Campus Box 7574, 115H Beard Hall | 301 Pharmacy Lane
Chapel Hill, NC 27599-7574
Graduate/Post-Graduate Program Manager
UNC Eshelman School of Pharmacy
Campus Box 7574, 115H Beard Hall | 301 Pharmacy Lane
Chapel Hill, NC 27599-7574