Senior Manager, Managed Access Programs

Regeneron Pharmaceuticals • Sleepy Hollow, WY

3d • Onsite

About The Position

The Senior Manager, Managed Access Programs will be responsible for all operational aspects of multiple projects/programs such as Expanded Access Programs, individual patient expanded access, and post-trial access managed by Medical Affairs. Based on team assigned, this role may include supervision of staff. Additionally, this role will support other MA projects, as requested.

Requirements

• Bachelor’s degree required
• 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.).
• Strong communication and presentation skills for senior management audiences.

Nice To Haves

• Advanced degree preferred
• Compassionate Use or Managed Access programs preferred

Responsibilities

• Operational responsibility across multiple projects/program(s) with minimal direction: Expanded Access Programs, individual patient expanded access, post-trial access
• Participates in team review meetings, product team alignment meetings, and program budget & status update meetings as needed
• Accountable for financial forecasting accuracy of Managed Access Programs within span of responsibility
• Maintenance of program budget trackers for each molecule/activity, ensuring all communicated actuals and accruals are captured, projections are reforested as necessary, and brand give back are fully assessed
• Maintains financial forecast for programs for quarterly for reporting to Accounting & Finance, and responsible for ensuring issue resolution for all discrepancies
• Responsible for managing drug supply for Expanded Access Programs and individual patient expanded access, as appropriate
• 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
• Manages vendors and financial tracking as required per program
• Ensures appropriate archiving of projects’/programs’ essential documents
• 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
• 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
• Development of 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, and involve senior levels of management to obtain adequate resolution
• Ensures financial transparency and alignment with both Alliance and internal stakeholders, supporting the product team financial reviews

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: Senior