Documentation Manager

Type of placement:         Contract – 12 months
Start date preferred:        01/12/2018
Location:                        Basel, Switzerland

Main Responsibilities:

• Design and/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area. Manage system and/or process Implementation in collaboration with Business and IT Functions
• Act as Business Analyst/Lead to manage the implementation of Document Management Related Applications:

• Orchestrate business requirements across NVS and identify achievable business benefits
• Coordinate and participate in system testing activities such as User Acceptance and

• Performance Qualification Testing to ensure business benefits are reflected

• Support the design of training concept(s) and training material
• Provide input to technical teams for migration and support migration testing
• Plan, prepare and oversee rollout and change management activities (communication and training)

• Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
• May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with system support and business functions.

Specific Tasks:

• Drive finalisation of deliverables related to a migration project of clinical documents to an archiving repository (finalisation of indexing and data structures, OCR upgrade)
• Support SMEs with Clinical Document Management Related Working Procedures and Training Material update for NVS electronic Document Management System (Clinical and Safety Documents)
• Support general business support and training tasks in the area of clinical document management (clinical submission documents as well as TMF documents)

Qualifications and Experience:

• Minimum Bachelor’s degree in life science/healthcare or equivalent
• Languages: Fluent English (oral and written), German of advantage
• Experience:
• • General knowledge of GCP processes in particular Good Documentation Practice with focus on electronic Document Management
  • Minimum 2 years experience with software and/or process implementation and related migration activities.
  • Minimum 2 years experience working in global, virtual project teams
  • Experience with Documentum-based solutions for Clinical Document Management
  • Knowledge in using Sharepoint on a business admin level of advantage
• Relevant working/residency permit or Swiss/EU-Citizenship required.