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R&d Project Leader
il y a 1 mois
Overview:
Mithra is looking for an R&D Project leader to join its R&D department to work at Mithra headquarter (Liège).
**Responsibilities**:
As Project Leader, you will participate actively to pharmaceutical products’ development and will be responsible to manage and coordinate the projects in the most efficient way.
Within the Project Management department, you will report to the Head of PM dept and you will work with the project team and international partners.
- Establish and maintain projects’ plan, timeline and budget.
- Ensure a good knowledge of the different parts of the Project(s) and review essential documents if required.
- Ensure and manage interactions and follow-up with the internal stakeholders (CMC, CDMO, RA, non-clinical, clinical, Medical, PV, etc) to ensure the good progression of the projects.
- Ensure and manage interactions and follow-up with the different external collaborators (incl. senior advisors and opinion leaders) to ensure the adequacy of the development plan and the good progress of the projects.
- Organize project meetings or others upon request, prepare for each meeting an agenda and the minutes.
- Constantly monitor and provides timely, comprehensive project status reports, including budgets and timelines.
- Ensure the documentation traceability and archiving.
- Collaborate closely with the accounting department for the follow-up of orders and invoices.
- Collaborate with the legal department for contractual aspect with sub-contractor.
- Perform risk management, proactively identify significant project risks, develop mitigation strategies, escalates to leadership, and implements approved mitigation steps.
Qualifications:
- Master or PhD in Biochemistry, Biology, Pharmacy, Chemistry or equivalent
- Previous experience in Project management and/or Product development is required
- Knowledge of Regulatory guidelines for pharmaceutical product development is required
- Knowledge of GLP, GCP and GMP guidances is an asset
- Autonomy and proactivity
- Excellent organization and coordination skills
- Strong oral & written communication skills (English & French) and cross functional collaboration skills
- Flexible, able to set priorities and solution oriented
- Good team skills and ability to work in an interdisciplinary and international environment