This position will lead a small team of Scientific Liaisons (SLs) specialized in Personalized Medicines and will report to the Senior Director Healthcare Quality and Safety (HQS).This role serves as the leader in managing the Personalized Medicines efforts of the Compounding Expert Committee and other associated activities. The incumbent shall be recognized internally as the key opinion leader to provide the scientific background needed to establish new areas of concentration in the Personalized Medicine arena, including but not limited to new technologies required for medical device standards, compounding preparation monographs, and General Chapters.
Roles and Responsibilities
Provide guidance to senior management on Strategic Planning and presentations for Compounding/Personalized Medicine Standards and pipeline.
Plan and manage the Expert Committee member selection for the new cycle and provide guidance in preparing 5-year work plans.
Mentor scientific liaisons in preparing new chair for assuming leadership of the incoming Expert Committee.
Provide guidance to the SL Team in forming Subcommittees and Expert Panels for the new 2020-2025 Compounding Expert Committee and executing workplans.
Develop/Lead presentations to USP leadership on plans/work status related to HQS, Expert Committees and SLs
As key opinion leader, provide consultation and guidance to scientific liaisons and USP partners as it relates to issues surrounding personalized medicine and related public health issues.
Provide interpretation and guidance on subject correspondence pertaining to health- related inquiries.
Keep abreast of the latest research, trends, and new developments current trends and developments specific to Personalized Medicines.
Manage delivery of high-quality documentation for Expert Committee Meetings and subcommittee WebEx working meetings.
Serve as a USP key opinion leader for Personalized Medicine at regulatory meetings, professional organization events and scientific meetings.
Grow USP’s brand as a thought leader in the field of Personalized Medicines through public presentations, seminar attendance and speaking events. Provide support and presentation assistance for USP HQS educational activities.
Mentor the scientific liaisons in their career paths and leadership skill development
Generous paid time off – 14 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 ($250/individual or $500/family)
Pharmacist with PharmD/ Pharmacist Attorney with 6 years experience (or MS in Health-related field with 8 years experience or equivalent education/years experience)
Minimum of 4 years’ experience managing, leading teams, or mentoring.
Possess knowledge of patient safety issues and National Strategy for Quality Improvement in Healthcare.
Possess knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and/or codes as they relate to pharmaceutical products and compounded preparations.
Possess 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 Alert on exposure to antineoplastic drugs.
Strong analytical skills, project management skills as well as experience overseeing strategic initiatives required.
Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
Results driven with demonstrated successful outcomes.
Possesses strong coaching and management skills.
Familiarity with key pharmacy/professional organizations (ASHP, APHA, NABP, ANA other)
Telecommuting is allowed.
Internal Number: 1696-679
About United States Pharmacopeia
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.