Overview
On Site
Full Time
Skills
Process automation
Service desk
Change request management
IT service management
Computerized system validation
Continuous improvement
Information Technology
Relationship management
Business analysis
Project management
Information management
IT security
IT operations
Software configuration
Change control
Application Support
High availability
Information systems
Data integration
Customer service
Problem solving
Solution delivery
Production support
Collaboration
Management
Oracle Linux
Data
Documentation
SAP BASIS
Training
Software deployment
ITCM
GxP
Knowledge base
FOCUS
Veeva
Salesforce.com
Analytics
Privacy
Auditing
Corrective and preventive action
Communication
IDEA
Design
GAMP
Innovation
Agile
SAFE
Scrum
Kanban
DevOps
Job Details
Job Description:
We are seeking a highly motivated Sr Analyst to support Kite Medical Affairs on their digital technology needs You will work with the Information Technology team in supporting our efforts in this exciting new area of cell therapy.
This role will work closely with the Medical Affairs functions to deliver technology solutions that meet our critical business needs This important role requires relationship management, business analysis, and project management skills as well as hands-on technical knowledge for various solutions such as External Scientific Collaboration Management, OL Engagement, Real World Data and their applications in Clinical Development, and among others.
Key Accountabilities:
Serves as functional resource and subject matter specialist for Medical Affairs Information Management Systems
Collects, documents, and manages user, functional, and technical requirements for Medical information management systems for the Cell Therapy business areas
Interacts with end users on a regular basis to understand their needs and provide guidance and training on technical solutions
Evaluate internal and external solutions to find the best fit.
Makes recommendations on business process automation and improvement with digital technologies
Participates in system release and post-deployment support activities with Quality, System Owners, IT Security, IT Operations, and IT Service Desk
Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures
Provides day to day application support with managed service teams
Troubleshoots technical issues and manages problems through to resolution
Develops processes to ensure high availability of supported application systems
Documents common resolutions/solutions and application support processes in the IT Service Management knowledgebase
Requirement:
Preferred Qualifications:
At least 8 years of experience working with medical affairs information systems
Deep understanding of the late stage clinical development and commercialization lifecycle with specific focus on Medical Affairs business domain/technologies enabling core functions such as external scientific collaboration management, Real World Data and their applications in clinical development as well as broad medical inquiry management, and field medical affairs
Broad clinical development business and IT capability awareness and hands on experience including global implementation experience with Veeva, Salesforce, iEnvision / Datavision, real world data integration and related analytics, medical platform-based solutions
Deep understanding of security and privacy regulations, GDPR, internal/external Audits and CAPA management and anticipate future technology need
Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills
Work experience and strong knowledge of end-to-end IT software and systems solution delivery from idea conception, design, development and/or configuration, and transition into production support and maintenance
Computer System Validation (CSV), and GAMP5 experience a plus
Strong focus on process, continuous process improvement and quality to enable innovation
Proven track record of working in Agile (e.g SAFe, Scrum, Kanban) and DevOps ways of working in the IT landscape
We are seeking a highly motivated Sr Analyst to support Kite Medical Affairs on their digital technology needs You will work with the Information Technology team in supporting our efforts in this exciting new area of cell therapy.
This role will work closely with the Medical Affairs functions to deliver technology solutions that meet our critical business needs This important role requires relationship management, business analysis, and project management skills as well as hands-on technical knowledge for various solutions such as External Scientific Collaboration Management, OL Engagement, Real World Data and their applications in Clinical Development, and among others.
Key Accountabilities:
Serves as functional resource and subject matter specialist for Medical Affairs Information Management Systems
Collects, documents, and manages user, functional, and technical requirements for Medical information management systems for the Cell Therapy business areas
Interacts with end users on a regular basis to understand their needs and provide guidance and training on technical solutions
Evaluate internal and external solutions to find the best fit.
Makes recommendations on business process automation and improvement with digital technologies
Participates in system release and post-deployment support activities with Quality, System Owners, IT Security, IT Operations, and IT Service Desk
Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures
Provides day to day application support with managed service teams
Troubleshoots technical issues and manages problems through to resolution
Develops processes to ensure high availability of supported application systems
Documents common resolutions/solutions and application support processes in the IT Service Management knowledgebase
Requirement:
Preferred Qualifications:
At least 8 years of experience working with medical affairs information systems
Deep understanding of the late stage clinical development and commercialization lifecycle with specific focus on Medical Affairs business domain/technologies enabling core functions such as external scientific collaboration management, Real World Data and their applications in clinical development as well as broad medical inquiry management, and field medical affairs
Broad clinical development business and IT capability awareness and hands on experience including global implementation experience with Veeva, Salesforce, iEnvision / Datavision, real world data integration and related analytics, medical platform-based solutions
Deep understanding of security and privacy regulations, GDPR, internal/external Audits and CAPA management and anticipate future technology need
Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills
Work experience and strong knowledge of end-to-end IT software and systems solution delivery from idea conception, design, development and/or configuration, and transition into production support and maintenance
Computer System Validation (CSV), and GAMP5 experience a plus
Strong focus on process, continuous process improvement and quality to enable innovation
Proven track record of working in Agile (e.g SAFe, Scrum, Kanban) and DevOps ways of working in the IT landscape