Responsibilities
Job Description
We are working on one of Clients Engagements for a FirstDoc Product Architect with a one of global leader in consulting, technology and outsourcing providing business consulting, technology, engineering and outsourcing services to their clients in over 30 countries. Our Client has a global footprint with 60+ offices and 70+ development centers in US, Asia, Australia, Japan, Middle East, Europe, Canada and many other countries having 140,000 employees.
Some Interesting Points regarding the Role:
Type: Permanent
Location: London, UK
About us:
We Avance Consulting are one amongst the UKs fastest growing talent acquisition companies. Head quartered in London, we are a global reach agency with a large presence in India (Gurgaon and Hyderabad) and UAE (Dubai). We cater our Client in their manpower needs and try to present the best and the most qualifies consultants needed.
Our Client is desperately looking for FirstDoc Product Architect.
Regulatory Document Management
Design and Implement a Regulatory Document Management Solution using FirstDoc R&D (FDRD), FDSPX, Documentum and SharePoint
Sound knowledge and expertise in configuring FDRD Application
Identify and design various configuration elements of FDRD (Workflows, State Configurations, Security, Document Definitions, Type/Subtypes etc)
Fine Tune the solution at every layer across all the components for high performance and availability
Experience in Integrating the solution with legacy systems (Enterprise Search, eArchive, Taxonomy, eDiscovery, Semantics) using Enterprise Service Oriented patterns and architecture. Oracle ESB preferred
Able to configure and fine tune DocWay Integration services
Design and deploy Documentum Components EMC Documentum, Rendition Servers, Trusted Content Services, Information Rights Management, Branch Office Caching Services, ACS etc
Good understanding and exposure to WebLogic Application Servers, Oracle Database
Submission Management
Design, configure and implement Regulatory Submission solution with eCTDXpress, ISIPublisher, VLM, Toolbox
Fair understanding of the validation submission patterns, knowledge and experience with Global Submit
Understanding of Submission Standards and 21CFR Part 11 Compliance
Tracking
Design and implement a regulatory tracking solution
Understanding of the object model and integration with other components
Product Lifecycle management, Health Authority Interaction Management, Manufacturing Authorization etc
Planning and ToC preparation
Experience/Knowledge of CSC Tracker or ArisGlobal Register
Please feel free to contact me for further information OR drop your CV to