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BioSpace

Donations Engagement Manager - Remote Position

BioSpace, Topeka, Kansas, United States

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Donations Engagement Manager - Remote Position

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Donations Engagement Manager - Remote Position

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BioSpace About 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. 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. Job Overview

This role is a non-supervisory position responsible for working with key customers and stakeholders in the excipients 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 USP monograph donations for excipients and other raw materials through effective and appropriate stakeholder engagement. The incumbent works directly with companies with raw materials or testing of raw materials that are included in FDA approved products/processes as well as with internal USP staff globally including: Program Units, Strategic Customer Development Managers, Scientific Experts, and Business Leaders. This includes management of day-to-day activities including company meetings, planning, reporting and tracking to ensure delivery of key targets and growth goals. This role 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 Division and reports to the Donations Director. Key Responsibilities

Develop donation-focused 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. Develop specific plans and performance targets that support overall donation strategies. Deliver on monograph donation targets, ensuring quality data/components for further development by Science 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 engage in business and relationship development activities with identified donors and other relevant stakeholders. Leverage internal USP resources to effectively position all relevant USP resources to further the mission of USP. Regularly execute professional presentations to donors to include, but not limited to the C-suite, Regulatory Affairs, Quality and R&D departments (and their respective staff). Develop 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. Understand the relationship between USP

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