Senior Consultant – Regulatory Operations Software Implementation
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, technical abilities to create corresponding technical solutions, and 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