Senior Consultant, Clinical Operations
Veeva Systems
CloudOracleVault
Senior Consultant – Regulatory Operations Software Implementation
Veeva Systems
full-time
Posted on:
Origin: • 🇺🇸 United States • Pennsylvania
Visit company websiteSalary
💰 $80,000 - $200,000 per year
Job Level
Senior
Tech Stack
CloudOracleVault
About the role
- Lead life science customers in the configuration and implementation of Veeva’s Regulatory suite (Veeva Registrations, Veeva Submissions, Veeva Submissions Archive, Veeva Publishing) to streamline global regulatory processes
- Manage software implementation projects and customers through the full implementation lifecycle, including project planning, requirements gathering, migration, configuration, validation, and go-live activities
- Conduct configuration requirements workshops then design, prototype, configure and thoroughly document content solutions
- Think critically about business requirements to ensure the solution reflects business requirements and focuses on Veeva best practices, customer success, and long-term adoption
- Guide our customers and internal team with program and project management including resource planning, leading, and motivating the cross-functional team
- Serve as the primary customer liaison managing communication, risks, and project reporting between the project team, customer, and internal stakeholders
- Mentor project team and consultants with a focus on continuous growth
- Collaborate cross-functionally with Product, Strategy, Sales, and other teams across Veeva
Requirements
- 8+ years experience working with or for organizations in life sciences or healthcare
- Direct technology system implementation, maintenance, or continuous improvement experience either as a consultant, business, or IT representative
- Proven track record leading high-impact system implementations and the ability to collaborate and manage diverse stakeholders and ensure delivery to a high degree of satisfaction
- Ability to act with speed to understand requirements and technical abilities to create corresponding technical solutions; willingness to “roll up your sleeves” to design and implement a RIM solution
- Knowledgeable in life sciences compliance and computer systems validation requirements
- Typical travel is 25% but may be up to 50% based on customer requirements
- Direct experience with systems such as Veeva Vault, PAREXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems
- Consulting experience, working with a major system integrator or software vendor in services delivery management and/or systems implementation
- Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background including in-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing, and/or Viewing systems
- Execution experience with Agile methodology and/or ACP Certification
- SaaS/Cloud experience