Consultant - Regulatory System Implementation - R&D (Remote)

Pennsylvania - Philadelphia

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Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 750 customers, ranging from the world's largest pharmaceutical...
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Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.
We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.
Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.
The Role
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!  Veva’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. 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

  • 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 40-70%; 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
#LI-Remote
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.
Job region(s): North America
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