Regulatory Software Consultant (Remote)
Employment Type: Full-Time
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.
Do you love solving business problems with technology? Are you an innovator? Do you love to learn and thrive navigating new situations and environments? Come help us transform how regulatory information is managed in Life Sciences! Veeva’s Vault RIM suite is the industry’s only unified software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management, submission publishing and archival on a single cloud-based platform.Veeva Systems is looking for Life Sciences Consultants with system implementation experience and a passion for helping customers optimize their regulatory data and document management process.As a key member of our Professional Services team, the Consultant will be responsible for understanding our customers’ global regulatory needs, translating requirements into solution design, and defining global strategies for deploying our cloud-based solution for managing regulatory information across the enterprise.Opportunities are available across the United States for this role.
What You'll Do Play a critical role on software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs Rapidly configure and implement the Vault RIM suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing) which is used to manage regulatory affairs and regulatory operations content and data in the cloud Lead requirements workshops, design, prototype, configure and document content management/registration data solutions Perform project management tasks including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting Work closely with business and IT staff from the clients to understand their requirements. Think critically to help them design the solution they actually need; not just the solution they think they need Ensure customer success from beginning to end of the engagement life cycle
Requirements 3+ years of experience working with or for Life Sciences companies; including, Pharmaceutical, Biotechnology, Healthcare, and Medical Device and Diagnostics organizations with knowledge of drug development processes and regulatory submissions System implementation experience either as a consultant, business or IT representative for at least one of the following systems: Document Management (Documentum, OpenText, Sharepoint) Registration Data Tracking Systems XEVMPD, IDMP Submission Publishing and/or Viewing systems Knowledge of drug development processes and regulatory submissions Proven ability to collaborate with diverse stakeholders and ensure delivery to a high degree of satisfaction Excellent communication skills – written, verbal and formal presentation Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution Ability to work independently in a fast-paced environment Ability to travel 50-70%; easy access to an airport 4-year degree 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, PAREXEL/ LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, other regulatory information management or submission publishing systems, etc. Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations or Pharma covigilance background Knowledge of Medical Device and Diagnostics regulatory processes, data and content Knowledge of Software Validation processes and requirements Life Science, computer science or related degree SaaS/Cloud experience Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
Perks & Benefits Flexible PTO Allocations for continuous learning & development Health & wellness programs
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