Freelance Consultant Risk Management (m/w/d)

Zu besetzendes Projekt: Freelance Consultant Risk Management (m/w/d)
Projektstart: 01.10.2023
Projektdauer: 31.12.2024
Auslastung: Vollzeit 80% vor Ort
Einsatzort: Deutschland

Objectives:
At the end of the project, we need to have accomplished the following objectives:
R&D Enterprise risk management process, material (tools and educational material) and implementation plan
Incl. description/guidance for different R&D Risk Management processes/tools and their interfaces
Quality Risk Management process assessment report with improvement plan
Promote risk management as a key element of quality mindset
Task Description:
To achieve the objectives, we need external consulting for the following activities:
Analysis of current Healthcare R&D risk management process, including the quality risk management process (scope of the analysis: process, documents (one Standard, one SOP, three Related Tools), training material, communication)
Development and implementation plan of the E2E R&D Enterprise Risk Management process aligned to the strategy and covering stakeholder engagement, process, document (one Standard or SOP), tools, educational/training material, system improvements
Development and implementation plan of the improved R&D Quality Risk Management process as per analysis results covering stakeholder engagement, process, tools, educational/training material, system improvements
Development of strategy and related material to promote risk management as a key element of quality mindset
Provision of ISO 31000 training and certification to the Risk Management team