The U.S. Pharmacopeial Convention (USP) Senior Editorial & Content Manager (Remote/Virtual) in Rockville, Maryland
Summary of the Position
For over 200 years, the US Pharmacopeia has developed and published standards for drug substances, drug products, excipients, and dietary supplements. These standards have been recognized in the Federal Food, Drug and Cosmetic (FD&C) Act since it was enacted in 1938. Today, USP standards are used in over 20,000 locations around the world.
The individual in this role will help USP make the transition to next-generation machine-readable standards in support of industry transition to Pharma 4.0. This hands-on individual contributor is responsible for development, editing, and publishing, externally facing USP electronic laboratory databases and associated products. The individual will work in the Digital & Innovation division on the Translational Informatics team, along with partners across USP to ensure that USP delivers high quality digital content that can be integrated into laboratory information systems, electronic laboratory notebooks, and digital laboratory instrumentation. This role is open to remote work.
Roles and Responsibilities
Manages content of external facing USP datasets related to structured monograph content, digital assay methods, chromatographic columns, and reagents
Refine and augment ontologies and data structures relevant to laboratory automation
Lead development and execution of the ETL process from compendial to machine-readable forms; guide development of automated ETL tools, including those leveraging NLP
Ensure accuracy and maintenance of content resulting from the ETL process
Engage with external stakeholders to gain deep technical understanding of laboratory automation needs and challenges
Works with technical and science teams to create requirements and/or enhance tooling for structured monograph content as to ensure functional adequacy, scientific accuracy, and timely publication
Creates and documents editorial rules and SOPs as needed
Represents USP in relevant external meetings and committees with other consortiums, standards setting bodies, government agencies, etc.
Monitors external data sources for internal data alignment (e.g., CAS, UNII, CHEBI, Allotrope Foundation)
Works with manager to develop and track progress along accurate project plans defining approach, timelines, and deliverables
Works with manager to establish technology roadmaps to achieve efficient and effective delivery of stakeholder value for machine-readable USP standards
Seeks and flags opportunities to enhance impact of existing data, including through integration with other internal or external data sets
Editorial and Content Manager
BS in chemistry, biology, or related field
Five (5) years of relevant experience in pharmaceutical R&D lab, QA/QC lab, lab automation, digital lab operations, or software development in the appropriate domain
Senior Editorial and Content Manager
BS in chemistry, biology, or related field.
Ten (10) years of relevant experience in pharmaceutical R&D lab, QA/QC lab, lab automation, digital lab operations, or software development in the appropriate domain
MS in Health Informatics, Computer Science, Data Science, or a related field
Experience in creation and/or maintenance of private or public electronic databases that are used in Laboratory Information Systems (LIMS), Electronic Laboratory Notebooks (ELN), or similar laboratory implementations
Experience in digital product quality assurance and data quality and governance
Proficiency in customer, professional engagement in technical aspects of laboratory automation, and ability to translate needs and challenges into digital product requirements
Experience in mapping/editing laboratory and chemical information to vocabulary standards such as UNII, CAS, CHEBI, IUPAC, etc.
Experience in using software to edit, version, publish, and evaluate quality of controlled terminologies and/or classifications
Experience in usage of data models and ontologies in the laboratory domain such as ADM and AFO from the Allotrope Foundation
Experience with tools such as Python, Unix, R Studio, Tableau, MySQL/Oracle, Protégé, XML/DITA/BaseX or other tools and software to query and analyze unstructured or structured data
Ability to communicate end-user requirements to software developers to enhance technical platforms
Ability to handle multiple priorities in a fast-paced environment.
Strong people and organizational skills
Excellent communications skills, including both verbal and written
Ability to present and impart knowledge to diverse audiences, including both technical and non-technical ones
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021, are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time