Product Specialist Consultant in Quality Assurance (EDMS/QMS/LMS) and/or Regulatory Affairs (Publisher/RIM) software

Full time
Duluth, GA, Raleigh, NC, San Jose, CA, USA
Posted 4 months ago

The Product Consultant collaborates with the Project Manager to lead and operate on delivering project deliverables requested for the implementation of Ennov Quality and/or Regulatory software. This position request to understand the pharmaceutical industry processes and have a minimum of IT skills to work properly within the system, and/or discuss with the technical teams.

Duties & Responsibility

The Product consultant performs a wide range of duties including some or all of the following:

Business analysis

  • Read and understand the customer User Requirement Specifications
  • Centralize all customer documents that help to conduct the business analysis
  • Prepare, lead and report the business analysis meetings
  • Write and deliver the functional specifications and/or design specifications

Implementation

  • Lead the installation of Ennov software with the integration/hosting team
  • Configure the system according to the internal Good Practices (no IT skill required)
  • Lead and operate the Data migration activities
  • Lead the integration activities with the technical team
  • Write and deliver the configuration specifications

Validation and User Test Acceptance

  • Lead the software validation process (IQ, OQ, PQ)
  • Write and deliver the validation documents
  • Assist the customer on written protocols, test scripts
  • Assist the customer on execute the test scripts
  • Track any Non-conformances, and establish an action plan to fix them

Training

  • Schedule and plan user training sessions
  • Perform Functional Administrator training
  • Perform Key and End user training
  • Coordinate with the technical team the technical training
  • Write or update the training materials

GoLive and Support

  • Ensure the system GoLive goes smoothly
  • Handle the process of customer change management
  • Support the customer on any issue during and after the project

Expected Behaviour

  • Treat others with dignity and respect
  • Support and promote intra- and inter-departmental teamwork
  • Understand and consider the needs and impacts of your own work on others
  • Demonstrate an ability to problem-solve and make timely decisions
  • Actively seek and receive feedback for improvement
  • Consistently share knowledge and information

Supervision

The Product consultant works with the Ennov US Team. S/he will report to the VP Sales and Professional Services North America.

Supervisory Responsibilities

When the person in this position will be hire, s/he does not supervise other employees. In the future, according the business development performance and the growth of the company in the US, s/he will be able to create and manage a team.

Skills and Qualifications

Applicants will be degree (BS minimum required) qualified in Life sciences or Computer sciences, have a minimum of 48 months relevant experience and be prepared to learn and adapt to this challenging position.

The following skills are recommended:

  • Applicants can present both verbal and written work to diverse audiences, including customers, technical colleagues, and management. English language is required, Spanish or/and French is a plus.
  • Excellent knowledge of the drug life cycle environment, especially in quality assurance or regulatory affairs. Clinical Trial and Pharmacovigilance is a plus.
  • OR/AND Excellent knowledge on IT (JavaScript, Database, Cloud environment) and one or several types of software from the industry: EDMS, QMS, LMS, Publisher, RIM, xEVMPD/IDMP.

Physical/mental Demands and Work Environment

While performing the responsibilities of the job, the employee is required to talk and hear. The employee needs to be mobile and available for travel. Vision abilities required by this job include close vision to the screen. Ability to focus, analyze and assess information.

Job Features

Job CategoryProjects

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