Veeva is a mission-driven organization that aspires to help our customers in Life Sciences and Regulated industries bring their products to market, faster. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, and Speed. Our teams develop transformative cloud software, services, consulting, and data to make our customers more efficient and effective in everything they do. Veeva is a work anywhere company. You can work at home, at a customer site, or in an office on any given day. As a Public Benefit Corporation, you will also work for a company focused on making a positive impact on its customers, employees, and communities.

The Role

Become an agent of change in life sciences. Join Veevas RIM Business Process Consulting 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; youre ready to transform businesses.

Roll up your sleeves and dive in! As a key member of our RIM Business Process Consulting team, the Senior Consultant will work side by side with our customers. You will drive the effort to understand the customers current state, pain points, and process gaps. Youll 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 work anywhere, full-time permanent role with Veeva. Our work processes are designed so that you can be productive in the environment that works best for you. 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)

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, developing user requirements to facilitate solutions to achieve the business vision and address key use cases.
Lead client process analysis engagements, building alignment within the customer user groups, and working 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 50-75%Bachelors 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, 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

Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) for this employment position.

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Veevas 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.