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Consultant
Regulatory Process Management, R&D, Remote
Confirmed live in the last 24 hours
Locations
Dorchester, Boston, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Requirements
  • 4+ years of direct experience working with regulatory in life sciences companies
  • System experience either as a consultant, business, or IT representative for at least one of the following systems: Document Management (e.g. Documentum, OpenText, Sharepoint, etc.) Registration Data Tracking Systems, SPL, Publishing Tools (e.g. eCTDXpress, InSight, etc.)
  • Working knowledge of life sciences compliance, regulatory guidance, and sponsor quality assurance requirements
  • Ability to quickly understand business use cases and opportunities for change, to create corresponding process and business model improvements
  • Familiar with governance models for process and system management
  • Experience managing diverse stakeholders and ensure delivery to a high degree of satisfaction
  • Ability and willingness to “roll up your sleeves” to analyze and develop process and training material
  • Proven ability to work independently in a dynamic, fast-moving environment and thrive. You may reside anywhere in the mainland US with easy access to an airport. Ability to travel 40-70%
  • Bachelor's degree or equivalent required
  • Qualified candidates must be legally authorized to be employed in the United States. Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Responsibilities
  • Work with customer subject matter experts globally, and business leaders to analyze, develop, and implement Regulatory processes that solve business problems and support business needs through the use of the Vault RIM suite (Submissions, Submissions Archive, Registrations, and Publishing)
  • Analyze and document current state business processes, identifying pain points and gaps in process or system functionality as areas of opportunity
  • Formulate recommendations for improvement in business processes and system configuration, develop user requirements to facilitate solutions to achieve the business vision, and address key use cases
  • Lead client process analysis engagements built alignment within the customer user groups and worked as a liaison with the implementation team and/or Veeva product team in a Vault RIM implementation project
  • Coordinate with the Veeva implementation team across multiple phases and workstreams (e.g. solution design and configuration, systems integration, data migration, validation, and training)
  • Develop end-user training strategies and deliver supporting materials (e.g. web-based learning, user guides, etc.) to support system deployment
  • Ensure customer success from beginning to end of the engagement life cycle
  • Identify, define, and deploy best practices through internal Preferred Vault Practices, aligning with industry guidance and maintaining a competitive advantage
Desired Qualifications
  • Direct experience with systems such as Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems or publishing tools
  • Consulting experience, working with a major software vendor or process management consulting group
  • Regulatory Affairs, Regulatory Operations, or Submissions Management background
  • Operational Change Management experience, either having led or supported cross-functional change management programs
Veeva Systems

1,001-5,000 employees

Cloud computing services for pharmaceutical companies.
Company Overview
Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.
Benefits
  • Parental leave
  • PTO
  • Free food
  • Health, dental, & vision insurance
  • Gym membership reimbursement
Company Core Values
  • Do the Right Thing
  • Customer Success
  • Employee Success
  • Speed