Medical Affairs Manager

2 weeks ago

Santa Monica, United States Cube Hub Inc. Full time

Job Title: Sr. Analyst - (Agile, Medical Affairs, )

Location: Santa Monica, California

Job Duration: 6 months


We are seeking a highly motivated Sr. Analyst to support client 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


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

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