Senior Project Manager

Job Location(s) US-PA-Horsham
Posted Date 4 weeks ago(1/26/2018 3:35 PM)
Job ID
2018-28785
Category
Medical Services
Position Type
Contract (Full-Time)
# of Openings
1

Overview

Project Manager - FDA Final Rule for Post-marketing Safety Reporting (PMSR) for Combination Products. 

 

Our client is working to implement a process to ensure compliance with the FDA Final Rule for Post- marketing Safety Reporting (PMSR) for Combination Products.  A combination product is a product composed of any combination of: drug, biologic or device.  The goal of PMSR is to protect the public health by ensuring a combination product’s continued safety and effectiveness once on the market. Instead of having two separate reports for Adverse events and reportable Product Malfunctions, one combined MedWatch form is preferred to be submitted to FDA.  The compliance date for the Final Rule is July 19, 2018. 

Project Management support is required to ensure timely execution of the implementation plan to meet compliance with FDA Final Rule.  

 

Responsibilities

Project Management support is required for the following areas:

  • Maintain an overall integrated project plan and communicate key interdependencies across work streams. Co-ordinates with other workstream project leads
  • Provides direction to the project teams for deliverables due as well as the overall status of the project
  • Ensures that outstanding project management, process implementation and design requirements and/or issues are being addressed
  • Collate weekly dashboard updates for core team meetings as well as support the development of presentations for Steering Committee and Executive Sponsor meetings
  • Distribute meeting minutes and track actions to closure
  • Support development of an iterative pilot framework, including table-top exercises through to system simulation; outline products, resources, scenarios and timelines to be tested for each pilot phase
  • Finalize end-to-end process maps
  • Support maintenance of project content in SharePoint
  • Ad hoc work stream support, as needed i.e. schedules workshops and meetings as required

Key Deliverables

  • Integrated project plan (Feb)
  • Finalized high-level and detail level process maps (Feb)
  • Weekly work stream dashboard maintenance (Feb-July)
  • Biweekly Steering Committee and Executive Sponsor updates (Feb-July)
  • Pilot framework and project management (Feb-Jun)
  • Go-live implementation (July)

Qualifications

  • PMP certified Project Manager
  • Experience with program management and coordination of multi workstreams
  • Minimum of Bachelor degree in life sciences with 3 years pharmaceutical experience; understanding of GXP requirements
  • Strong presentation, communication, interpersonal skills required
  • Detail oriented, performance driven, strong decision-making skills
  • Ability to function in a global matrix environment
  • Proven experience developing presentation materials for an executive audience
  • Proficiency with MS Office 365 (PowerPoint, Excel, Word, and Visio)

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