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Senior Manager, Medical Operations, Expanded Access Programs

Regeneron · Sleepy Hollow, NY · 4 days ago
HybridManufacturing$134k–$219k/yrFull-time

Program Management

Operational responsibility across multiple projects/program(s) with minimal direction: Expanded Access Programs, individual patient expanded access, post-trial access.

Meetings & Committees

Participates in team review meetings, product team alignment meetings, and program budget & status update meetings as needed.

Budget Management

  • Accountable for financial forecasting accuracy of Managed Access Programs within span of responsibility.
  • Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies.

Drug Supply

Responsible for managing drug supply for Expanded Access Programs and individual patient expanded access, as appropriate.

Metrics & Reporting

  • Responsible for ongoing analyses, tracking and reporting of projects/programs support, timelines for completion, expected or assessed delays, solutions for streamlining processes for greater efficiency, and other related metrics in support of program activities.

Vendor Management

Manages vendors and financial tracking as required per program.

Essential Documents

Ensures appropriate archiving of projects’/programs’ essential documents.

Systems Management

  • Utilizes appropriate systems to contribute to cross-functional communication, planning and transparency, including but not limited to:
  • Ensures ongoing QC of SharePoint document storage for completeness and audit readiness.
  • Expertise required in the utilization of QlikSense, QlikView, SharePoint, Oracle and ESRA portal to support team needs.

Process Adherence

  • Adheres to all relevant processes, trainings, and SOPS to ensure consistency, efficiency, and compliance.
  • Exercises' judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions;
  • Continued process improvements

Organizational Goals

Develops objectives in order to quantify success and attainment of goals. Ensures optimal structure, procedures, and adequate resources supporting growth of multiple projects/programs.

Knows When to Escalate Issues

Knows when to escalate issues, and involve senior levels of management to obtain adequate resolution.

Alliance Management

  • Ensures financial transparency and alignment with both Alliance and internal stakeholders, supporting the product team financial reviews.

Qualifications

  • A bachelor’s degree is required and an advanced degree preferred.
  • 5- 8 years’ experience working in clinical research or medical operations within the pharmaceutical or biotech industry.
  • Active working experience and/or courses pertaining to clinical research and/or MA areas (such as GCP, Investigator Initiated Studies; medical/educational grants administration; medical information; registries; OIG/PhRMA guidance.).
  • Career in Compassionate Use or Managed Access programs preferred.
  • Strong communication and presentation skills for senior management audiences.

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