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.

Qualifications

• 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.
• The following Qualifications are Required:

o Expertise in Veeva RIM, Veeva Submissions, Archive, Veeva QMS, Veeva Quality Docs ·

• The following Qualifications are preferred:

o Experience with Regulatory Affairs Strategy, Intelligence, Regulatory Information Mgt & Operations, and/or Submission Publishing domains in support of market authorization.
o Experience with Audits, Inspections, Vendor Oversight, and issues management such as SSNs. CAPA, and risk management.
o Experience with Architecture Frameworks/Processes (e.g. TOGAF) and help define patterns and other architectural accelerators.
Education & Certifications

• Bachelor's Degree

Job Type: Contract

Pay: $72.00 per hour

Experience level:

• 10 years
• 11 years

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• designing Clinical and Regulatory GxP and non-GxP IT: 10 years (Required)
• Clinical and Regulatory GxP and non-GxP IT: 10 years (Required)
• Veeva RIM: 8 years (Required)
• Veeva Submissions: 6 years (Required)
• Veeva QMS: 8 years (Required)
• Veeva Quality Docs: 8 years (Required)

Ability to Commute:

• Basking Ridge, NJ 07920 (Required)

Ability to Relocate:

• Basking Ridge, NJ 07920: Relocate before starting work (Required)

Work Location: In person