Documentation Manager

Basel, Switzerland
On Application
02 Nov 2018
12 Jan 2019
Contract Type

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.

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