Technical Integrator - CMC Module 3
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
The Sr Technical Integrator is responsible, with some managerial guidance, for developing the technical eCTD sections to support Regulatory CMC dossier applications (module 3).
- Contribute to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
- Communicate and execute dossier strategy/product development plan
- Direct responsibility for project budgets
- Lead and supervise dossier authoring activities for early and late stage projects
- Interface directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD customers
- PhD + 3 years of relevant experience // University degree + 6 years of relevant experience.
- Experience with module 2.3 and module 3 writing.
- Very good communication skills in English
For more information please contact Guilherme Tokunaga at email@example.com or +31 (0) 20 658 98 01.