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US Pharmacopeia logo
US Pharmacopeia

The Standard of Trust.

Senior Digital Standards and Strategic Collaborations Manager

ManagerManagerFull TimeRemoteSeniorTeam 1,001-5,000Since 1820H1B No SponsorCompany SiteLinkedIn

Location

Maryland

Posted

86 days ago

Salary

$134.1K - $173.9K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

Senior Digital Standards and Strategic Collaborations Manager

US Pharmacopeia

• 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.

Job 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

  • Company-paid time off
  • Comprehensive healthcare options
  • Retirement savings

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