Senior Business Analyst, m/f/d, 100%, Basel
Updated: 30 Apr 2022
You contribution to our team
As a member of our Managed Services Project for our Lifesciences Customers, the Senior Business Analyst (BA) is responsible for scoping, planning and supporting the successful implementation of Pharma Regulatory Information solution ensuring Submission in EU countries as per Clinical Trial Regulation (CTR) EU No 536/2014, Global CTAs, INDs and Authorized Medicinal Products.Provide business analysis, AS IS assessment of legacy systems, best practice research, defining TO BE process and data definition, detailed requirements and user stories and supporting user acceptance facilitation. In addition, required to work closely with Business Users, Product Owners, Data Architects, Product Managers, IT Business Partners and IT Architects to develop a conceptual architecture for the solutions.
Your Key Responsibilities
- Analyze business scenarios that may potentially be solved by the implementation of automated systems and/or modifications to business processes
- Provide expertise in the identification, evaluation, design, development, and deployment of systems and/or processes
- Assessment of legacy systems and processes and defining effective TO BE processes
- Assessment of HA Portals such as EMA CTIS Portal and other HA gateways
- Play a key role – as part of the project team or M&E – in delivery of solutions that are cost-effective, sustainable, and meet business requirements
Accountable for documentation, which may include, but is not limited to:
- User Requirements
- EPICs, Features and User stories
- Functional and/or technical specifications
- Process flow diagrams
- User Roles & Responsibilities
- Security Matrix to support both local and global requirements for both internal and external business partners
- Document Classification Matrix and Folder structure
- Training documentation and/or work instructions
- Depending on the application and/or function, may configure system settings and/or options
- Provide consultation to customers regarding enhancement/improvement of current solutions and implementation of new solutions – both systems and processes
- Facilitate and/or support customers in UAT planning and execution
- Participate in and advise roadmap discussions, a key member of vendor assessment teams
- Drive resolution of business or systems issues
- Prepare presentations Day in a Life workshop
- Bachelor’s degree in Computer Science, Information Systems or equivalent work experience
- Minimum 10 years work experience as a business analyst of which at least 2 years within the Pharma industry
- Experience in at least 2 data migration projects
- Strong Project experience in IT Projects (preferred software development lifecycle)
- Highly experienced in business analysis, assessment of AS IS data, processes and applications and defining TO BE business processes. Learning new business domains, business process analysis and design, usability and the ability to facilitate workshops in combination with customer centric focus
- Experience in creating documentation: User Requirements, User Stories, Product Backlog, Test scenarios, Process Maps, Guidance Documents, Feature Traceability, Process-Data Mapping, Data flows, Training Material/ Work Instructions, Document Classification / Metadata Matrix, Product Roadmap etc.
- Kledge of CTAs, INDs, CTR etc.
- Kledge of data standards such as IDMP 6 and data standardization techniques
- Familiar with CDISC, BRIDG, HL7 and other related pharma development data standards
- Understands the concepts and principles of data modeling and able to produce relevant data models across multiple subject areas. Understands industry-recognized data modeling patterns and standards. Kledge of data modeling/architecture principles and techniques.
- Advanced experience with Agile methodologies (e.g., Scrum, SAFe)
- Experience in collecting both functional and nonfunctional requirements in categories: Process/Data/ Documents/ Migration/Integration /Security etc
- Working Kledge of Documentum, Veeva RIM, Veeva eTMF, Veeva CTR
od to have:
- Experience in Pharma Regulatory Projects
- Experience in Submissions like IND, CTA, and Health Authority Interaction
- Kledge of Content Management, Workflow Management, Archiving, Registration, Publishing and Robotic tools
- Working Experience of Jira
- Kledge of Veeva Clinical
If you feel attracted by this challenge, please apply online with your complete application in PDF format (incl. Motivation Letter, CV, Work Reference Letters and Diplomas).
Our recruitment partner Livio Gerber from RECOGNITO HR Services will take care of your application. For further information please contact him on +41 44 201 08 34.
Please note that we do not consider candidate dossiers from recruitment agencies