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Regulatory Implementation Consultant/Manager - North America

  • LORENZ Life Sciences Group
  • Philadelphia (PA)
  • Publiziert: 06.05.2022
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Who we are

We are the LORENZ Life Sciences Group – worldwide market leader for software solutions for digital exchange between the pharmaceutical industry and international authorities. Our customers trust in the know-how and commitment of our approx. 120 employees worldwide, who work successfully at the interface between science and technology every day. Our products increase the efficiency of the drug approval process and make a direct contribution to making necessary therapies available to patients more quickly. Support us in improving the lives of people who are dependent on new drugs and therapies. Become part of our successful team and grow with us!

Your responsibilities

  • Manage projects including customer kickoffs, implementation from initiation to go-live, upgrades and third party hosting implementations
  • Perform installation, validation, configuration and migration related services in North America
  • Providing advice internally as well as to external customers/prospects regarding products, services, and industry trends
  • Working with 3rd party cloud staff or AWS cloud staff
  • Manage customer communications with effective written and verbal communication skills. Ensure that project scope and deliverables meet SOW, SLA, MSA requirements

Your profile

  • Bachelor’s Degree in Computer Science, Regulatory Affairs or other related discipline
  • 3+ years of experience in regulatory affairs and regulatory information management, especially document management, submission management, product information/life cycle management
  • Expertise in client-server applications, virtualization platforms, database systems (SQL), PDF, cloud-based systems (AWS or Azzure) and XML Language
  • Prior experience in validation processes and an understanding of validated environments, IQ, OQ and PQ documentation
  • Strong presentation, public speaking, written communication skills
  • Ability to work independently and remotely

We offer

  • A competitive salary and 401K plan
  • Employee and family health and dental insurance
  • Attractive vacation/holiday schedule
  • Work flexibility/ability to balance work from home office

Your contact in the recruiting process

Ms. Yaprak Eisinger
(Managing Director, North America)
E-Mail: hr@lorenz.cc