The U.S. Pharmacopeial Convention (USP) (Associate) Scientific Liaison - Personalized Medicine (Pharmacist) in Rockville, Maryland
Summary of the Position
This is a professional individual contributor position that will be part of the Healthcare, Quality & Safety Center of Excellence under the Personalized Medicines group. This role will be responsible for contributing to the development of future standards and solutions for Personalized Medicine that address the needs of healthcare professionals as well as for supporting key workstreams of USP Compounding standards. This includes partnership and collaboration with USP Expert Committees, external experts and cross-functional teams on exploring key topics such as emerging technologies, pharmacogenetics, or other emerging areas through leading critical evaluation of relevant literature, scientific data and evidence and development of priority standards and solutions. This position will also support the development of new compounded preparation monographs through the Compounded Preparation Monograph Donation Program (CPM Donation Program) and be responsible for prioritization of CPMs for the Compounding Compendium including review of relevant literature, analytical method development, validation and stability studies.
In addition, this position coordinates and facilitates the workplans related to the above with all relevant USP’s Expert Committees and healthcare practitioner input into USP standards-setting activities. This individual will drive outreach to key stakeholders at key conferences and related events and coordinate development of key stakeholder forums, workshops, roundtables and education to foster engagement and promote adoption of these standards.
Roles and Responsibilities
Participates in planning and organizing of activities of the Expert Committee, subcommittees and Expert Panels to guide the development and revision of standards.
Keeps abreast of current trends and developments in new technologies, pharmacogenetics, digital therapeutics and other emergent areas and provides recommendations for potential application of these areas to personalized medicines generally and compounding in particular
Works with the senior manager to develop concept papers, stimuli articles, and other position papers on personalized medicines for use when communicating with other USP departments and external stakeholders
Acts as USP liaison for governmental inter-agency activities
Identifies opportunities for and collaborates in the development of implementation tools including external stakeholder forums, communications, education course development and digital tools
Participates in the development and implementation of enhanced initiatives for stakeholder engagements on draft and final standards such as forums, workshops, roundtables and other events.
Provides needed guidance on general and specific subject correspondence pertaining to compounding monographs, general chapters and various USP policy issues both internally and externally including response to inquiries and stakeholder issues.
Drives global outreach to key USP regional teams and Global Health and Manufacturing Services department to identify and engage with global stakeholder organizations. This includes presenting at international and national meetings and participating in relevant discussions. Provides assistance and guidance for standards that can impact global health stakeholders.
Associate Scientific Liaison:
Pharmacist with a doctoral degree in pharmacy, chemistry or pharmaceutics and 5 years (or MS and 7 years) of relevant experience in compounding, personalized medicines, pharmacogenomics or related field; alternatively pharmaceutical, biotechnology or life science industry experience may be applicable. An equivalent combination of experience and education may be substituted (e.g., RPh, MPH, MS in Nursing, Pharmacy or Healthcare related field).
Pharmacist with a doctoral degree in pharmacy, chemistry or pharmaceutics and 8 years (or MS and 10 years) of relevant experience in compounding or personalized medicines; alternatively pharmaceutical, biotechnology or life science industry experience may be applicable. An equivalent combination of experience and education may be substituted (e.g., RPh, MPH, MS in Nursing, Pharmacy or Healthcare related field).
Experience in global pharmaceutical policy is a plus.
Experience in analytical chemistry and compounding is a plus.
Microsoft Office Suite proficient.
Understanding and knowledge of organizational development within the context of non-profits.
Operates collaboratively at all levels of the organization in a highly technical environment.
Possesses knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and/or codes as they relate to compounding. Possesses knowledge of the FDA’s Drug Quality and Security Act of 2013, Compliance Policy Guide (CPG) for both human and animal drug use, OSHA regulations on hazardous drugs, and NIOSH Alerts on exposure to antineoplastic drugs.
Understanding of USP standards-setting processes and compendial terminology. Expertise in contemporary compounding practices and associated professional activities. Knowledge of global pharmaceutical and healthcare industries and related trade associations.
Well-developed organizational, interpersonal communications, negotiation, writing, attention to detail, and strong listening skills.
Strong analytical skills and ability to work on basic processes as well as strategic initiatives required. Expertise in evaluating research of evidence-based information. Demonstrates creativity, flexibility, and the ability to develop and review effective Expert Committee and Expert Panel work plans consistent with organizational mission and objectives.
Strong presentation and overall communication skills, both written and oral.
Able to effectively prioritize and efficiently manage multiple programs.
Able to operate independently where appropriate yet understand when to escalate issues and how to establish effective working relationships in a team setting.
No supervisory responsibilities.
USP offers an impressive benefits package, including:
Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.
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 Chemistry & Scientific Standards
Job Type Full-Time