Senior Consultant - Regulatory Process Management - R&D (Remote)

Veeva Systems

Veeva Systems

Legal
Philadelphia, PA, USA
Posted on Thursday, July 14, 2022
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead.
At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.
Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.
The Role
Become an agent of change in life sciences. Join Veeva’s RIM Process Development team in transforming the way Regulatory teams manage their regulatory information, their submission documents, their product registrations, and the way they correspond with health authorities around the world.
Veeva is looking for Senior Consultants with deep regulatory expertise and a passion for helping customers improve their process for Regulatory Information Management (RIM), submission management, publishing, and submission archiving. We want team members ready to challenge the status quo; you’re ready to transform businesses.
Roll up your sleeves and dive in! As a key member of our RIM Process Development team, the Senior Consultant will work side by side with our customers. You will drive the effort to understand the customer’s current state, pain points, and process gaps. You’ll develop the future state vision to meet their global regulatory needs, define user requirements to inform solution design, and develop long-term strategies for ongoing process improvements.
This is a remote, full-time permanent role with Veeva. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.
Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) for this employment position.

What You'll Do

  • 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 process and system configuration, develop user requirements to facilitate solutions to achieve the business vision, and address key use cases
  • Lead client process analysis engagements, build 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 competitive advantage

Requirements

  • 10+ 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.)
  • Expert on 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
  • Strong understanding of governance models for process and system management
  • Proven ability to manage 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 U.S. with easy access to an airport
  • Ability to travel 40-70%; Bachelor’s degree or equivalent required

Nice to Have

  • 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, Docubridge, 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

Perks & Benefits

  • Flexible PTO
  • Allocations for continuous learning & development
  • Health & wellness programs
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Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com. Position may not be eligible for remote work in Colorado.