A job vacancy for a Document Manager has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas
- Support the definition and refinement of the document management strategy for Clinical Documentation relevant for Regulatory Submission, such as Clinical Trial Protocols, Clinical Study Reports, etc.
- Design and/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process ar-ea. Manage system and/or process Implementation in collaboration with Busi-ness and IT Functions.
- Act as Business Analyst/Lead to manage the implementation of Document Man-agement Related Applications:
o Orchestrate business requirements and identify achievable business benefits
o Coordinate and participate in system testing activities such as User Ac-ceptance and Performance Qualification Testing to ensure business bene-fits are reflected
o 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 inter-nal SOPs
- May act as Business Administrator in the electronic Document Management Sys-tem (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with system support and business functions.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.