Clinical Documentation Coordinator
Il y a 2 mois
Janssen Research & Development, part of the Johnson & Johnson Family of Companies, is recruiting a **Clinical Documentation Coordinator **.
The position will be based in Beerse Belgium.
The Clinical Pack & Tech department a division of the CSC (Clinical Supply Chain) organization is part of the global Janssen Research & Development organization within Johnson & Johnson.
We are responsible for Clinical packaging for all clinical studies of J&J. The activities include primary and secondary packaging and labelling activities internally and with our external partners through a global network. For our Clinical Pack & Tech department in Beerse we are looking for an enthusiastic colleague to create clinical labels and batch records in a team of Clinical Documentation Coordinators.
- The Clinical Documentation Coordinator (CDC) supports the Clinical Source Documentation Specialist by executing all packaging and labelling activities.
- The CDC is mainly responsible for label and order creation of a broad portfolio of all clinical studies.
- The CDC is the single point of contact (SPOC) for the Clinical Source Documentation Specialist, operations and Local Medication Coordinators. They gather all information needed for internal pack activities and internal & external label activities.
- The CDC will work closely together with different CSC functions.
- Label and order creation is executed in of NGENCODAC (New Generation Coding and Accountability Application for Packaging and Labelling), they ensure that labelling complies with source documentation, local requirements, and technical specifications.
- The CDC is responsible for timely upload of approved labels into submission data base conforming to system requirements and naming conventions.
- The CDC must embrace the “Patient First” philosophy. Flexibility is a must in the clinical environment where demands and priorities are constantly changing.
**Qualifications**:
**Qualifications**:
- You have a bachelor's degree or equivalent through experience.
- You have a result and performance driven mentality.
- You have the ability to work in cross cultural environment and multi-disciplinary teams.
- You have the ability to take initiative and to work independently but collaborate when necessary.
- You have knowledge and experience with GMP activities and GDP guidelines. Specific expertise in Clinical Packaging & Label requirements is an asset.
**Job requirements**:
You got energized by:
- Rewarding to work on multiple projects and areas at the same time.
- Rewarding to deliver precision work: it’s got to be perfect
- Rewarding to work on innovative, complex issues and to simplify these issues.
- Being a critical thinker and able to take leadership in change and optimization.
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