TMF Manager

Regeneron Pharmaceuticals

4d • Remote

About The Position

At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. We are looking for a TMF Manager, you’ll play a critical role in maintaining inspection-ready Trial Master Files (TMFs) that support groundbreaking therapeutic advancements. Reporting to the Head of TMF Operations, this remote role offers the chance to collaborate globally, drive quality, and make a meaningful impact. This is a temporary 6 months role.

Requirements

• Applicants must hold a Bachelor’s degree or equivalent, with at least 5 years of relevant experience.
• Familiarity with TMF Reference Model and eTMF systems is essential.
• Strong communication and organizational skills are required, along with proficiency in Microsoft applications.

Responsibilities

• 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.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager