US Pharmacopeia · 1 day ago
Senior Digital Standards and Industry Solutions Manager (REMOTE)
United States
Contract
Remote
Senior Level, Lead/Staff
$134K/yr - $174K/yr
10+ years expThe U.S. Pharmacopeial Convention (USP) is an independent scientific organization focused on developing quality standards for medicines and food ingredients. The Senior Digital Standards and Industry Solutions Manager will lead efforts to drive industry adoption of digital standards in drug development and regulatory submissions, fostering partnerships and pilot programs to demonstrate their value.
MedicalNon ProfitPharmaceuticalPublishing
Responsibilities
Lead strategic engagement with pharmaceutical companies, regulators, and other relevant stakeholders to promote the adoption of USP’s digital standards in regulatory filings
Develop and manage pilot programs with early adopters to validate the use of digital standards in real-world regulatory scenarios
Collaborate cross-functionally with USP’s scientific, regulatory, and digital teams to align industry needs with solutions development
Represent USP externally at industry forums, conferences, and regulatory roundtables to advocate for digital standards and share pilot outcomes
Build and maintain strategic partnerships with key stakeholders across industry, regulatory agencies, contract organizations, and technology providers
Monitor and report on adoption metrics, feedback from pilot participants, and market trends to inform strategy and product evolution
Qualification
Required
Bachelor's degree in regulatory affairs, pharmaceutical sciences, data science, public policy, or a related field
Minimum of ten (10) years of experience leading strategic collaborations in pharmaceutical development, regulatory affairs, digital transformation, or related areas
Prior experience contributing to regulatory submissions for pharmaceutical products, such as in a regulatory or CMC role
Experience with and knowledge of domestic and international pharmaceutical industry regulations
Experience with digital transformation in pharma (e.g., structured data, FAIR principles, digital QC/QA workflows, LIMS/ELN/CDS systems)
Familiarity with USP Standards and their use
Excellent communication and interpersonal skills
Preferred
Master's degree in life sciences (chemistry, biology, pharmaceutical science, engineering, etc.) or business
Familiarity with digitalization challenges and opportunities within the pharmaceutical industry
Strong change leadership acumen and problem solving abilities
Rigorous account development and management frameworks
Demonstrable commitment to public health/patient safety/consumer protection
Ability to engage with technical teams and translate between scientific, regulatory, and digital stakeholders
Understanding of how Standards can be integrated into digital systems
Entrepreneurial mindset
Ability to influence without authority
Comfortability with ambiguity and change
Benefits
Company-paid time off
Comprehensive healthcare options
Retirement savings
Company
US Pharmacopeia
US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820.
1001-5000 employees
H1B Sponsorship
US Pharmacopeia has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ronald Piervincenzi
Chief Executive Officer
Stan Burhans
SVP Operations and Chief Financial Officer
Recent News
Company data provided by crunchbase