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CMC Project Manager
- CMC Project Management
About Our Client
Our client is a biotech company specialised in inflammatory diseases.
- CMC projects management with a focus on effective planning, coordination of activities and communication.
- Development of project plans to ensure deliverable and timelines.
- Communication to align project activities with the Global Product Development plan.
- Liaison with external suppliers and main stakeholders.
- Interface with clinical and nonclinical material demand and providing of appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
- Coordination of CMC team meetings, publishing clear and concise meeting agendas, minutes and action items.
- Monitoring risks to ensure team engagement and work with the team to refresh risks and mitigation as needed.
- Responsible for project documentation review and archiving.
- Identification of the required documentation and any content, quality and timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Review of relevant CMC sections of regulatory documentation.
The Successful Applicant
- 3 years of CMC project management experience.
- Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects.
- Previous experience in supporting eCTD Module 3 regulatory submissions.
- Excellent communication skills.
- Fluent English is required.
What's on Offer
Great opportunity to join an expanding biotech company.