The Alliance for Building Better Medicine (ABBM), including partner USP, aims to accelerate pharmaceutical industry growth and sustainability as part of an NSF Regional Innovations Engines Development Award. As part of this effort, USP is developing a regulatory pathway framework for the Alliance. The framework will establish regulatory standards in line with manufacturing modalities for the ABBM. USP is seeking a Technical Writer to assist in the development of a best practices document that can be leveraged by current and new ABBM members to supplement the framework.
This consultancy has a performance period from October 2025 to June 2026.
Location of Assignment: Remote
Scope of Work:
Work with USP to develop a high-quality report that captures the findings into clear and concise language for both technical and non-technical audiences, including:
· Leverage desk review conducted by USP team to synthesize identified best practices into a cohesive, easy-to-understand document
· Meet virtually with ABBM to receive feedback on document
· Work in collaboration with the USP team to incorporate feedback and finalize document for dissemination
Deliverables:
· Best Practices Document to include but not limited to background, synthesis of identified best practices, and application to regulatory pathways framework.
Required Qualifications:
· Bachelor’s degree in Biology or Chemistry, Communications, Journalism, English, or equivalent professional experience.
· Demonstrate a solid understanding of regulatory concepts and the ability to translate them into clear and concise language.
· Minimum 3 years of professional experience developing and producing a variety of written materials. Excellent writing skills.
· Proven ability to meet deadlines and pay close attention to detail. Well-organized with demonstrated multi-tasking skills.
· Strong proficiency in Microsoft Office (including Word, Excel, and PowerPoint).
· Ability to work collaboratively in a face-paced, and deadline-driven environment. Strong attention to detail, excellent organization skills, and ability to
prioritize multiple tasks.
Preferred Qualifications:
· Professional experience with regulatory affairs and regulatory strategy preferred.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and foods for billions of people worldwide. We work to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health and Manufacturing programs work with donors and partners to implement practical, high-impact solutions to enable visibility, resilience, and security of the pharmaceutical supply chain.
