Job description: Responsibilities 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 8 years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representative In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction 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 dynamic environment Typical travel is 25% but may be up to 50% based on customer requirements Qualifications we seek in you Minimum Qualifications / Skills Bachelor's degree required in science, engineering or related field (advanced degree preferred) Preferred Qualifications/ Skills 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 Pharmaceutical, Biotechnology, and/or 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) English Fluency