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