CMC Reg Outsourcing Project Manager
il y a 3 semaines
The Regulatory CMC Department of our client is looking for a CMC Reg Outsourcing Project Manager.
Mission:
As part of CMC Regulatory Affairs (CMC Reg), the Outsourcing Project Manager is responsible for managing process improvement initiatives to support the outsourcing model for lifecycle activities. The Project Manager will collaborate with the CMC Reg Leadership Team and other stakeholders to optimise the global CMC regulatory activities in the context of product life cycle management. The Project Manager will develop project plans, document and implement solutions to enhance operational efficiency and effectiveness. In addition, the Project Manager will support the CMC Reg Outsourcing Manager with managing outsourced CMC Reg activities.
Activities and responsibilities:
Responsibilities :
- Work with internal and external stakeholders to understand process needs and constraints associated with current and process models for CMC Reg activities
- Review and analyse CMC regulatory processes to identify problems, inefficiencies and opportunities for improvement
- Document agreed processes in detail, including workflows, roles and responsibilities
- Identify and implement performance indicators to monitor process efficiency and identify opportunities for improvement
- Collaborate with internal and external stakeholders to implement proposed changes
- Support the CMC Reg Outsourcing Manager with defined activities associated with the outsourced portfolio
Qualifications/Experience/Skills :
- BS/ MS degree in a relevant field or related experience with >5 years experience in regulatory affairs and an indepth knowledge of the CMC regulatory environment
- Must be able to communicate effectively in the English language.
- Excellent analytical skills and ability to solve problems proactively
- Strong communication and collaboration skills
- Ability to work independently and manage multiple projects simultaneously
- Ability to distill agreed processes into easy to follow documented guidances
- Attention to detail and quality orientation
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