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Medical Affairs Technology Expert

4 months ago

Santa Monica, United States The Fountain Group LLC Full time

PAY: $110-125/hour W2
This is a hybrid role, seeking someone who can work onsite 2-3 days/week in Santa Monica, CA
W2 Candidates only, C2C not possible for this role. 
Responsibilities

  • 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 (Gilead) 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

Requirements

  • 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.

Who We Are:

The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.

Browse our website below for additional information on our company.

4505 Woodland Corporate Blvd, Tampa, FL 33614

“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”