Regeneron

ManagerMedicalStudyOperations

$115–187k Sleepy Hollow, New York, United States FULL TIME
The Brief

“Manager Medical Study Operations at Regeneron. Skills: Study operations, Medical affairs, Oncology research. Manage multiple projects. Ensure proposals align”

What You'll Achieve.

Ensure compliance with standards; Ensure compliance with regulations; Ensure compliance with packaging requirements; Ensure compliance with labeling requirements; Ensure compliance with country-specific requirements; Ensure compliance with regulatory requirements; Ensure consistency; Ensure efficiency; Ensure compliance

Industry & Context.

Eligibility Requirements

On-site 4 days/week, Relocation benefits

What They're Looking For.

Must Have

BAS degree, 7+ years industry experience, 7+ years relevant professional experience

Nice to Have

Experience in oncology, Experience in antibody research, Experience with Investigated Initiated Studies

What You'll Do.

Manage multiple projects

Ensure proposals align

Obtain necessary approvals

Facilitate meetings and committees

Coordinate scientific meetings

Track and report study progress

Ensure collection and archiving of documents

Ensure patent reviews and background checks

Collaborate with Site Budget & Contracting

Oversee study budgets

Manage purchase orders

Plan and coordinate drug campaigns

Manage drug shipments

Ensure timely receipt of SAEs

Coordinate internal review of publications

Ensure data capture in study tools

Adhere to all relevant processes

How You'll Work.

Team & Collaboration

Cross-functional teams; External investigators; Field Medical Team; Site Budget & Contracting; Legal; Procurement; Sponsor Institution

Process & Methodology

Project management, Program management

Free ATS check

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