10 дней назад
Director, Digital Standards Strategy and Regulatory Science (Pharmaceutical Standards)
167 343 - 238 464$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Digital Standards Strategy and Regulatory Science (Digital Standards/Pharmaceutical Quality): Defining the scientific framework, governance, and adoption strategy for USP’s digital pharmacopeial standards with an accent on regulatory alignment, policy development, and cross-functional portfolio oversight. Focus on convening regulators, standards bodies, government stakeholders, and pharmaceutical manufacturers, while building teams and implementation workflows for products such as USP-ID and MethodConnect.
Location: Remote; employees must reside in MD, VA, DC, PA, WV, CA, MI, IL, KS, FL, NC, or MN. The listed address is in Rockville, Maryland, United States.
Base salary: USD $167,343–$238,464 annually. Target annual bonus varies by role level.
Company
is an independent scientific organization that develops quality standards for medicines, dietary supplements, and food ingredients through global collaboration.
What you will do
- Define the scientific framework, enterprise strategy, operating model, and lifecycle governance for Digital Standards.
- Lead engagement with regulators, government agencies, standards bodies, scientific societies, and pharmaceutical manufacturers.
- Develop policy frameworks covering structure, lifecycle, metadata, interoperability, implementation guidance, and enterprise controls.
- Oversee the Digital Standards portfolio, including strategic alignment, budgets, forecasts, KPIs, and product direction for -ID and MethodConnect.
- Build and lead a multidisciplinary team across scientific development, policy, advocacy, strategic collaborations, and program management.
- Represent in conferences, publications, scientific forums, and regulatory discussions as a Digital Standards thought leader.
Requirements
- 10+ years of progressive experience in pharmaceutical sciences, analytical chemistry, regulatory science, or a closely related discipline.
- 7+ years of people management experience, including multidisciplinary team leadership.
- Experience implementing change across a matrixed organization and shaping governance, operating models, workflows, and policy frameworks.
- Demonstrated ability to align regulators, government stakeholders, standards bodies, and pharmaceutical manufacturers around a shared framework.
- Advanced degree such as a PhD, PharmD, or MS in a scientific, pharmaceutical, or analytical discipline, or an equivalent record of scientific leadership and publications.
- Remote employees must reside in one of the specified U.S. states.
Nice to have
- Experience with FDA, EMA, ICH, or another regulatory or standards-setting body.
- Knowledge of pharmacopeial standard setting and pharmaceutical product quality control.
- Experience with scientific content workflows, analytical methods, or digital method lifecycle frameworks.
- Experience with NMR, FTIR, MassSpec, HPLC, or related analytical chemistry technologies.
- Experience establishing strategic collaborations and drafting agreements with life science organizations.
Culture & Benefits
- Mission-driven work supporting access to safe, high-quality medicines worldwide.
- Inclusive and equitable scientific collaboration with professional development and leadership opportunities.
- Company-paid time off and comprehensive healthcare options.
- Retirement savings and programs supporting personal and financial well-being.
- Training in equitable management practices and tools for building inclusive, high-performing teams.
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