Medical Product Alert Project Manager

Medical Product Alert Manager will be working with Global Product Alert coordination team, leading medical Product Alerts (PA) and coordinating actions across entities and functions with the PA Team in partnership. The PA (project) manager will collaborate effectively and coordinate the activities pertaining to product alert management, across different functions, to ensure that the PA Team is aligned with all actions completed by the workstreams.

This includes but is not limited to the following:

• With the support of the Product Alert Coordinator, nominate core team members and adhoc PA team members, usually from global (and/or local) organizations or from Operational Units depending on the origin and the scope of the PA and in cooperation with the PA Coordinator and the Heads of involved Functions.
• Lead the PA Team, plan and lead all PA Team meetings.
• Schedule, organize and follow all PA actions across entities, including the establishment of all documentation.
• Prepare PA team meetings and minutes, distributing meeting minutes and seeking expertise as needed.
• Ensure follow-up of the status and completion of the action plan, including internal and external communications.

• Once the Product Alert is completed:
  • Propose and prepare for the closure of the PA, with an action plan to be closed as per the defined and agreed timelines.
  • Finalize the PA meeting minutes including the executive summary (with inputs from the PA Team) with all actions marked as completed as a part of closure activity for PA.
• Support strategic and operational guidance in a plain language for PA activities.

• People: (1) Maintain effective relationships with stakeholders; (2) Work closely with product alert coordination team, medical team, other cross functional teams, as needed and Country/ Regional medical teams; (3) Collaborate with Legal, Safety, Medical, Regulatory, Manufacturing and supply, corporate affairs, quality teams as per need 3) Serve as point of contact for all PA related activities for medical product alert.

• Performance: Per internal Sanofi requirements: (1) Lead the cross functional global and local functions for appropriate/efficient PA Management. (2) Conduct PA related activities (meetings, minutes, documentation, etc…) and ensure PA action plan follow-up until closure; (3) manage the medical PA documentation

• Process: Per internal Sanofi requirements (1) Setting up the PA team in agreement with the PA coordinator, scheduling meetings, preparing and distributing minutes. (2) Preparing action plan and communication plan and following it up to completion (3) Propose the closure once relevant and create and develop executive summary at the PA closure (with inputs from the PA Team members).
• Stakeholders: (1) Product Alert coordination team (2) Medical Operations, country / regional medical teams; (3) Legal, (4) Public Affair teams (5) R&D, CMO, Regulatory & PV teams G (6) Quality And other functions to support medical governance & compliance

About you

• Experience: 7+ years of experience in Managing complex projects in medical domain with an operational knowledge in QA, Regulatory, international regulations & standards.
• Soft skills: Strong organizational skills in matrix organization, very agile, excellent on communication and interaction skills, problem solving mindset, efficient way of working.
• Technical skills: Basic MS Office skills, Smartsheet & strong Project Management skills.
• Education: Bachelor/Higher Degree/ Medical Doctor.
• Languages: Excellent knowledge of English language (spoken and written)

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