Description:
Project/Department Description and responsibilities:
Global Regulatory Affairs (GRA), Submission Planning Solution(SPS) team is looking for an extra project lead.
SPS system allows GRA to provide a transparent overview of the planned submission of all Janssen product to all involved teams.
The system is in production since Sept 2010. The aim of the team is to include the last set of submission planning information in the system by end of this year. The project lead will drive this effort.
Responsibilities:
Tasks :
•Lead/analyze the implementation of the last set of submission types in SPS to complete the effort.
•Lead/analyze the discussions with the business
•Lead the implementation discussions with GRA-IT
•Lead the necessary training effort
Technical skills:
Priority 1 : It is important that the candidate has basic knowledge of Regulatory Affairs processes!
Knowledge of planning tools more specific Planisware would be appreciated but not necessary.
Project lead with good Negotiation skills
Personal skills:
Accepts personal responsibility for client satisfaction;
- Strong tracking, coordination and project planning skills;
- Establishes and manages engagement objectives, expectations and quality plan;
- Ability to identify and implement process and/or application improvements; - Strong analytical and problem-solving skills; - Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management procedures and internal guidelines; Methodology/Certification requirements: - Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred;
- Additional certification is a plus;
Language proficiencies: - English spoken and written;
- Dutch is a plus;
Salary package:
Contact name:
Dimitri Brigitta
Contact email:
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