Senior Digital Standards and Industry Solutions Manager
US Pharmacopeia
full-time
Posted on:
Location Type: Remote
Location: Maryland • United States
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Salary
💰 $134,100 - $173,900 per year
Job Level
About the role
- 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.
- Personally lead early pilot execution to demonstrate the value of Digital Standards.
Requirements
- 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.
Benefits
- Health insurance
- Retirement savings
- Company-paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsdigital transformationstructured dataFAIR principlesdigital QC/QA workflowsLIMSELNCDS systems
Soft Skills
communicationinterpersonal skillsstrategic engagementcollaborationpartnership building
Certifications
Bachelor’s degree in regulatory affairsBachelor’s degree in pharmaceutical sciencesBachelor’s degree in data scienceBachelor’s degree in public policy