Senior Standards Engagement Manager

Description
Who is USP?
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.
At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.
USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.
Brief Job Overview
This role is a non-supervisory position responsible for working with key customers and stakeholders in the biopharmaceutical industry on acquisition and complete submission of information for USP documentary standards, primarily in the North America (NORAM) and Europe Regions. This role will be responsible for delivering information needed to develop USP Standards for products listed on the USP Priority List and currently in the standards development process through effective and appropriate stakeholder engagement. The incumbent works directly with companies that hold FDA approvals or companies that supply drug substances used in FDA approved products. This position infaces cross functionally with Program Units, Strategic Customer Development Managers, Scientific Experts, Materials Acquisition, and Business Leaders. This role includes management of day-to-day activities including company meetings, planning, reporting and tracking to ensure delivery of key targets and growth goals. Success in this position requires excellent interpersonal and communication skills, with the ability to influence cross-functional teams and external stakeholders. This role is within the Regions & Program Operations and Strategy Division and reports to the Standards Engagement Director.
How will YOU create impact here at USP?
As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.
Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.
The Senior Standards Engagement Manager Has The Following Responsibilities
Develops donation focused on account strategies, driving ongoing collaboration and alignment across all relevant internal stakeholders/partners.
Lead monograph acquisition (donation) efforts globally, and as needed, with particular focus in NorAm and Europe at assigned companies.
Identify and develop key contacts for acquiring the information required to develop USP’s public standards. This includes the development of new monographs, modernization of existing monographs, and compendial requests to address FDA comments on proposed monographs to the USP-NF.
Develops account specific plans and performance targets that supports overall donations strategies.
Deliver on standards donation targets, ensuring quality data/components for further development by Science staff and USP Expert Committees, in an expeditious and efficient manner.
Educate, support, and assist the sponsor of a potential monograph with guidance related to USP and how USP fits into a comprehensive compendial strategy.
Regularly engages in business and relationship development activities with identified donors and other relevant stakeholders. Develops and nurtures relationships with key people and decisionmakers within each account. Leverages internal USP resources to effectively position all relevant USP resources to further the mission of USP.
Regularly executes professional presentations to donors to include, but not limited to the C-suite, Regulatory Affairs, Quality and R & D departments (and their respective staff).
Develops an overall understanding of USP’s business (Small Molecules, Biologics, Growth Programs) to ensure that conversations with donors can foster broader collaborative dialogue between USP and targeted donors.
Understands the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect USP and external accounts.
Has ability to provide scientific and technical support to assigned donors. Leverage internal USP counterpart resources such as Science, SCD, Scientific Affairs and USP Education, for inquires and/or programs that need greater detail and program content expertise.
Maintains and updates account information for all assigned accounts. Updates Contact Management system with all relevant donor information.
Use information strategically to be proactive at engaging USP resources.
Makes the requisite number of touch points (phone calls/emails/videoconferences/customer visits) to assigned accounts to the responsible individuals and decisionmakers on USP’s standards development process, and opportunities for donor contributions, with a primary focus on monographs; and documenting calls, meetings and emails in Salesforce.
Supports donor events and workshops to enhance and promote the importance of stakeholder contributions to the standards development process.
Identify contacts at assigned companies to work with USP on new monographs, monograph improvement and bulk material.
Develop and report on understanding key drivers and barriers for donations.
Keep track of the progress to goals, monthly.
Help to increase our understanding of the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect USP’s Mission.
Works as part of a Team leveraging the resources in donations operations and donor recognition to support our donors and elevate the impact our donors provide for global public health.
Travel can be up to 50%, both domestic and international.
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 below competencies and experience
Bachelor's degree in Chemistry, or a related science field required or business degree and/or related field experience.
Eight to ten (8 - 10) years’ experience, in a life sciences role preferably in the pharmaceutical industry, specialty chemicals, a contract service organization that does testing for pharmaceutical industry or