Regeneron

TMF Manager

Regeneron

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • Lead TMF Health initiatives to ensure accuracy and completeness.
  • Collaborate with CROs and internal teams to resolve documentation issues.
  • Present eTMF updates at study-related meetings.
  • Develop and maintain TMF plans and inventories.
  • Conduct reviews to confirm inspection readiness.
  • Communicate metrics and compliance updates to stakeholders.
  • Manage process improvement projects within the TMF organization.

Requirements

  • Bachelor’s degree or equivalent
  • At least 5 years of relevant experience
  • Familiarity with TMF Reference Model and eTMF systems is essential
  • Strong communication and organizational skills
  • Proficient in Microsoft applications
Benefits
  • health and wellness programs (including medical, dental, vision, life, and disability insurance)
  • fitness centers
  • 401(k) company match
  • family support benefits
  • equity awards
  • annual bonuses
  • paid time off
  • paid leaves (e.g., military and parental leave)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
TMF Reference ModeleTMF systemsprocess improvement
Soft Skills
communicationorganizational
Certifications
Bachelor’s degree