Regulatory Process Management – Consultant (Remote)
California - San Francisco
Posted 1 month ago
At Veeva, we build enterprise cloud technology that powers the biggest names in the pharmaceutical, biotech, consumer goods, chemical & cosmetics industries. Our customers make vaccines, life-saving medicines, and life-enhancing products that make a difference in everyday lives. Our technology has transformed these industries; enabling them to get critical products and services to market faster. Our core values, Do the Right Thing, Customer Success, Employee Success, and Speed, guide us as we make our customers more efficient and effective in everything they do.
Become an agent of change in life sciences. Join Veeva’s 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 Consultants with 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; ready to transform businesses.
Roll up your sleeves and dive in! As a member of our RIM Business Process Consulting team, the 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, 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 position. Opportunities are available across the mainland United States for this role.
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.
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 processes 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 a competitive advantage
- 5+ 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 thriveYou may reside anywhere in the mainland US with easy access to an airport. Ability to travel 50-75%
- 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.
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’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.