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IT eContent Management, Submissions and Publishing - Belgium  

Company managed [?] Still accepting applications
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Posted on : 28 May 2017

Project Description

 IT eContent Management, Submissions and Publishing 

 
 Scope: 
In this position, you are playing a key role in our department by having the responsibility of the IT activities (Projects & Run) related to the different systems and technologies supporting the Regulatory Submissions and Publishing processes. 

  

Accountabilities: 
Accountabilities of the person in this IT eContent Management, Submissions and Publishing role are :   
  • Contribute to the strategy and road-map for Submissions and Publishing  in collaboration with the company Global Regulatory Affairs (GRA). 
  • Collect requirements, build, implement & support standardized and globalized Submissions and Publishing solutions, to setup & maintain best-in-class processes. 
  • Give input  to the IT GRA Solution Manager via Focus Group and Governance board for the definition of the release strategy through the change management process. 
  • Formalize the IT provisions required to assist in the submissions process. 
  • Project delivery in close collaboration with all parties involved (stakeholders and IT, internal and external partners), following the company IT project methodology. 
  • Align and communicate with the company  Regulatory Affairs Knowledge Management team and Submissions portfolio Management team in order to develop & foster the utilization of new technologies (collaboration, social, digital, mobile,…). 
  • Follow market trends and industry best practices with the aim of sharing the acquired knowledge inside the company and of applying it to propose innovative solutions. 
  • Ensure compliance of the solutions to global process and legal requirements, follow validation guidelines and standard operating procedures 
  • Actively take part in the implementation of the company  strategy in view of creating value and foster IT as a Technology Practice.  
  



Expected skills & experience   
  • Master Degree in a relevant field. 
  • Young Talent with high potential for further development & evolution. 
  • Functional & technical knowledge of relevant solutions in Regulatory submissions and Publishing, more specifically in Veeva Vault Submissions and/or Lorenz DocuBridge. 
  • Project management expertise. 
  • Experience of working in an international, global context. 
  • Experience in managing relationships with business partners, external IT suppliers. 
  • Showing interest in the “trends of the new IT world” (Digital, Analytics, Big Data, Mobile Apps,…). 
  • Showing interest in the Pharma sector and in improving the life of patients living with severe diseases. 
  • Fluent English.  
  



Expected capabilities   
  • Be engaged to impact patients' life 
  • Have an open, positive attitude, pro-active, forward looking 
  • Be a team player across different teams and different levels of the organization 
  • Be agile by being able to perform at operational and tactical level 
  • Bring a fresh view... bring the outside world into the organization 
  • Embrace diversity  
  

    
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