Beschreibung
Lead Architect/Functional Analyst - Document Management Systems - Pharma background - GxP and 21 CFR part 11
Main Tasks
Act as Lead Architect in combination with a Functional Analyst role
Derivate requirements from analysis of business drivers, objectives and business analysis stream's output
Consult and influence requirements and functional designs using profound DMS best practices
Collaborate with Architects from other areas (Infrastructure, related solution teams, Software Architects, Enterprise Architects) to understand standards, dependencies and impacts. Drive alignment towards solutions
Track record to lead a software selection process, including management of selection criteria
Requirements:
Ability to perform a role of a Lead Architect in combination with Functional Analyst role
Deep knowledge of Document Management Systems, Functionality and Architecture, preferably Documentum and Sharepoint-based solutions
Ability to derive requirements from analysis of business drivers, objectives and business analysis stream's output
Ability to consult and influence requirements and functional designs using profound DMS best practices.
Background in pharmaceutical area, Clinical Operations or Regulatory; ideally in eTMF (electronic Trial Master File) or Dossier Submission related area
Knowledge of collaboration concepts and solutions required
Ability to contribute to project planning, including estimates of work packages.
Experience to work in validated environments, GxP and 21 CFR part 11
Team player and excellent communication skills
Ability to perform in distributed, virtual teams
Working language is English
Working location is Basel, Switzerland"
Project: May 2012 - August 2012, possible extension