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Role : Veeva RIM Expert
Location : Parkway, NJ(100% Remote)
Key Skill : RIM Suite
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 implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
- Lead configuration requirements workshops, design, prototype, configure and document content solutions
- Program and project management including resource planning, leading, and motivating a cross-functional team
- Primary customer liaison managing communication between the project team, customer, and internal stakeholders
- Mentor project team and consultants, helping others improve their consulting skills
Requirements
8+ years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representativeIn-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and / or Viewing systemsProven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfactionInfluential; experience leading teams through hard decisions and negotiating compromisesTechnical abilities and willingness to roll up your sleeves to design and implement a RIM solutionExpert on life sciences compliance and computer systems validation requirementsAbility to work independently in a dynamic environmentTypical travel is 25% but may be up to 50% based on customer requirementsNice 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 vendorRegulatory Affairs, Regulatory Operations, or Pharmacovigilance backgroundKnowledge of Pharmaceutical, Biotechnology, and / or Medical Device and Diagnostics regulatory processes, data and contentPMP certificationExecution experience with Agile methodology and / or ACP CertificationLife Science, computer science or related degreeSaaS / Cloud experienceLocality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)