As a Pharma Development Informatics Business Analyst (BA) you will be responsible for scoping, planning and supporting the successful implementation of technology solutions by providing business analysis, best practice research, detailed requirements and user stories definition and user acceptance facilitation. In addition you will be required to work closely with Business Users, Product Owners, Product Managers, IT Business Partners and IT Architects to develop a conceptual architecture for the solutions.
Your will help drive successful completion of major projects/programs across portfolios. Your impact may be within or across multiple portfolios and you will champion accountability by example.
Your initial assignment will be in the areas of drug development quality management related processes.
You will work on:
Identifying and documenting business processes and improvements for QMS domain in a GxP environment.
Identify opportunities for improvement and efficiencies gained by successfully adopting new QMS solutions i.e. Veeva.
Create high quality user and functional requirements and user stories
Work closely with the Product Owner to analyze requirements to determine priority and business value
Create and maintain prioritized backlog items for development
Facilitate meetings, document meeting notes and distribute meeting notes to invitees
Facilitate interviews, site visits and workshop sessions with business users one-to-one and in groups as needed
Create required regulatory and SDLC documentation
Create ASIS and to-be process maps and narratives
Create requirements traceability matrices
Provide estimates for workstream activities, including dependencies, to the Project Manager
Identify, manage and resolve risks and issues related to the workstream
Contribute to all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training
Work with project teams to ensure compliance with regulatory requirements such as FDA, CAPA, CLIA, GxP,HL7 as well as internal policies and processes
Create and deliver training materials to end users Collect and monitor progress on project activities from resources
The ideal candidate:
Brings a scientific background (e.g. biology, medicine, biochemistry, pharmacy, or data science). Knowledge of clinical studies
Has deep business process domain knowledge and stays abreast of technology innovation in their domains
Prior GxP and QMS related experience with CAPA, Change Control, Investigation Management, Document Management, Validation and Training
Extensive years in life sciences/pharma
Has excellent communication and influencing skills.
Has experience facilitating meetings and workshops
Always demonstrates leadership in his/her assignments.
Applies advanced theoretical knowledge and establishes new principles and concepts to independently address strategic business technology problems.
Exhibits intellectual curiosity and integrity and has strong passion to bring value-adding technology to the business.
Has experience working in agile environments and exhibits a mindset in the approach to:
Enable a diverse group of partners to speak with a single voice
Ensure the right information is available to the development team in the right level of detail at the right time so that the product can be developed.
Up-to-date knowledge of data technology trends and utilities in general, in particular for quality drug development.
Experienced with informatics systems, relational databases, SQL, and data visualization tools.