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Veeva Solution Architect

4 months ago

Bernards, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Collaborate with project team members to architect solutions per Business Requirements.
  • Perform analysis and design (functional/non-functional) activities to create clinical/Regulatory solution landscapes for our Life Sciences Clients.
  • Take complex concepts and articulate them to an audience of varying levels of expertise and subject matter expertise.
  • Provide direction to junior team members and support recruitment efforts.
  • Grow the capabilities of the team, develop best practices and accelerators.
  • Create high-quality assessments, health checks and clinical architecture, in support of solution design.
  • Recommend risk-based solutions to solve business needs.
  • Lead Solution review sessions and provide input to change control review and approval processes.
  • Have a proven track record leading discussions with senior management and executives as the subject matter expert.
  • 10+ years of experience designing and delivering Clinical and Regulatory GxP and non-GxP IT solutions.
  • Extensive Veeva Development Cloud background and demonstrated understanding of the key processes and sub-processes specific to Life Sciences.
  • Strong understanding of system and data security principles and best practices.
  • Willingness to "wear any hat " that is necessary to drive customer success.
  • Continue to extend subject matter expertise in the life sciences industry and learn Veeva Solutions.
  • Strong understanding of system and data security principles and best practices.
  • Good functional knowledge of Life Sciences Market Authorization processes.
  • Ability to communicate efficiently with technical and non-technical staff and members of interdisciplinary teams both verbally and in writing.
  • Keen attention to detail and proven analytical and problem-solving abilities.
  • Ability to handle multiple priorities and work under pressure.
  • Excellent problem-solving skills.
Requirements:
  • Expertise in Veeva RIM, Veeva Submissions, Archive, Veeva QMS, Veeva Quality Docs
  • The following Qualifications are preferred:
  • Experience with Regulatory Affairs Strategy, Intelligence, Regulatory Information Mgt & Operations, and/or Submission Publishing domains in support of market authorization.
  • Experience with Audits, Inspections, Vendor Oversight, and issues management such as SSNs. CAPA, and risk management.
  • Experience with Architecture Frameworks/Processes (e.g. TOGAF) and help define patterns and other architectural accelerators.
  • Bachelor's Degree