Regulatory Software Senior 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 want to lead a high energy team focused on solving complex 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 people who are intimate with the legacy business process and technologies used to author documents, build submissions and manage product registrations. We want people ready to challenge the status quo; ready to transform businesses.Roll up your sleeves! As a key member of our Professional Services team, the Senior Consultant will work side by side with the customers. You will drive the effort to understand the customers’ global regulatory needs, translate requirements into solution design, and define global strategies for deploying our cloud-based solution across the enterprise.Opportunities are available across the United States for this role.
What You'll Do Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs Lead the solution design for how your customer will implement and use the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing) Lead requirements workshops, design, prototype, configure and document content management/registration data solutions Architect multi-year and multi-phased implementation programs to deploy Vault RIM across an organization globally Program and project management including resource planning, leading and motivating a cross-functional team, and project tracking and forecasting Primary customer liaison managing communication between the project team, customer and internal stakeholders Mentor project team and junior consultants in the R&D Services organization 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 lifecycle
Requirements 10+ years experience working with life sciences companies 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, SPL, eCTD Labeling, Submission Publishing and/or Viewing systems In-depth 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 Influential; experience leading teams through hard decisions and negotiating compromises Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution Expert on life sciences compliance and computer systems validation requirements Ability to work independently in a fast-paced environment You may reside anywhere in the US with easy access to an airport. Ability to travel 50-70% 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, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, 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 Pharmacovigilance background Knowledge of Medical Device and Diagnostics regulatory processes, data and content PMP certification Execution experience with Agile methodology and/or ACP Certification 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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