Full-Time

Consultant

Regulatory System Implementation, R&D, Remote

Posted on 7/13/2022

Veeva Systems

Veeva Systems

5,001-10,000 employees

Cloud solutions for life sciences sector


Mid

Philadelphia, PA, USA

Required Skills
Communications
Management
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
Responsibilities
  • 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
Desired Qualifications
  • 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)

Veeva Systems offers industry cloud solutions for the life sciences sector, providing technologies such as Vault Clinical Data Management, Vault EDC, Vault Coder, Vault Clinical Operations, Vault RIM Suite, Vault Quality Suite, Vault Safety Suite, Veeva Medical Suite, Veeva Data Cloud, and Veeva Commercial Cloud to support critical functions from R&D through commercialization. These technologies aim to streamline quality processes, manage clinical data, and improve regulatory compliance for life sciences companies.

Company Stage

IPO

Total Funding

$224M

Headquarters

Pleasanton, California

Founded

2007

Growth & Insights
Headcount

6 month growth

3%

1 year growth

10%

2 year growth

37%

Benefits

Parental leave

PTO

Free food

Health, dental, & vision insurance

Gym membership reimbursement

INACTIVE