Sr. Manager RIMS
- Humac Inc
101 Days Ago
NA
NA
Park Ridge-NJ
6-10 Years
Required Skills: RIM Suite, Veeva’s Vault RIM suite
Job Description
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 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
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, 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
• 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 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
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, 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
