Responsibilities

  • Conduct research, surveys and interviews to gain understanding of the business and clients’ requirements
  • Detect issues and investigate ways to resolve them
  • Compile and Present information orally, visually and in writing
  • Make recommendations for improvement and present findings to client
  • Develop and implement new procedures or training
  • Support clients to implement new Business processes or maintain existing ones
  • Perform regular reports to the client and to the line manager – projects’ and clients’ follow-up
  • Contribute to the definition of current and future domain offerings in cooperation with the line manager
  • Able to manage human resources in Project mode (non-hierarchical dependence)
  • Able to train people as subject matter expert – related to the relevant expertise
  • Ensure customer satisfaction is monitored and relevant actions are taken to meet client satisfaction

Education

  • Master’s degree or higher graduate degree in a science related field

Experience

  • At least 2 + years’ experience in a similar role

Skills

  • Excellent knowledge of Regulatory information (xEXMPD, IDMP/SPOR, sets of data related to RIMS).
  • Knowledge of Regulatory Affairs processes in a Pharmaceutical environment
  • Advanced knowledge in one or several of the following tools (nonexhaustive list): – EDMS: Documentum, Sharepoint, Ennov Doc, VeevaVault Submissions
  • Serialization knowledge (EU FMD , Brazil, Middle East, China…)
  • Knowledge of other systems (ERP, Productlifecycle management…) and system interoperability.
  • RIMS: Veeva Vault Registrations, Register/LifeSphere, Liquent Insight, Ennov RIM
  • Fluent in English for daily contacts with local and international

RIMS Team Lead 642 (H/F/X)