Regeneron
SeniorManager,MedicalOperations,ExpandedAccessPrograms
“Senior Manager, Medical Operations, Expanded Access Programs at Regeneron. Skills: Expanded Access Programs, Medical Affairs, Program operations. Manage operational aspects of multiple projects/programs. Supervise staff”
What You'll Achieve.
Quantify success; Quantify attainment of goals
Industry & Context.
Issue resolution; Streamlining processes
What They're Looking For.
Must Have
Bachelor's degree required, 5-8 years experience in clinical research or medical operations, Experience in pharmaceutical or biotech industry, Active working experience or courses in clinical research or MA areas, GCP knowledge, Investigator Initiated medical/educational grants knowledge, Medical registries knowledge, OIG/PhRMA guidance knowledge, Communication skills for senior management audiences, Presentation skills for senior management audiences
Nice to Have
Advanced degree preferred, Compassionate Use programs preferred, Managed Access programs preferred
What You'll Do.
Manage operational aspects of multiple projects/programs
Support other MA projects
Manage drug supply for Expanded Access Programs
Manage drug supply for individual patient expanded access
Analyze projects/programs support
Track projects/programs support
Report projects/programs support
Report timelines for completion
Report expected or assessed delays
Identify solutions for streamlining processes
Manage financial tracking per program
Ensure appropriate archiving of projects’/programs’ essential documents
Utilize systems for cross-functional communication
Utilize systems for planning
Utilize systems for transparency
Ensure ongoing QC of SharePoint document storage
Adhere to all relevant processes
Adhere to all relevant trainings
Adhere to all relevant SOPs
Exercise judgment within defined practices
Develop objectives to quantify success
Develop objectives to quantify attainment of goals
Ensure optimal structure supporting growth
Ensure optimal procedures supporting growth
Ensure adequate resources supporting growth
Escalate issues when necessary
Involve senior management for resolution
Ensure financial transparency with Alliance stakeholders
Ensure financial transparency with internal stakeholders
Support product team financial reviews
How You'll Work.
Team & Collaboration
Cross-functional communication; Cross-functional planning; Cross-functional transparency; Alliance stakeholders; Internal stakeholders; Product team alignment meetings
Communication Scope
Senior management audiences
Process & Methodology
Program management, Project management
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