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  • Locatie

    Leiden, Leiden, Zuid-Holland

  • Functie titel:

    Technical Integrator - Module 3 CMC (15h/w)

  • Sector:

  • Job ref:

    46112

  • Start datum:

    2021-05-05

The Company 
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.

Role Description 
The Sr Technical Integrator is responsible, with some managerial guidance, for developing the technical eCTD sections to support Regulatory CMC dossier applications (module 3). 

Responsibilities 
- 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

Requirements 
- 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 


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 
Neem contact op

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804