Regulatory Business Analyst

4 days ago

Plymouth Meeting, Pennsylvania, United States W3Global Full time

Mandatory Skills: Pharma Regulatory systems / ENNOV RIM
Location: 1st Preference Candidates local to Plymouth Meeting PA / 2nd Preference Jersey City NJ (Must be onsite 2 to 3 days a week and for Workshops Must be local to area mentioned)
Must Have Experience

  • Business Analyst from Pharma who has experience with Ennov RIM who has done End to End RIM to RIM Migration (Regulatory Information Management)
  • Preferred candidate with Ennov RIM experience if they do not have that Viva RIM experience is ok.
  • Business analyst who understands what a RIM system does
  • Business Analyst who has experience with Gap Analysis, Data Mapping, Write & Develop requirements
  • Excellent communication who can work with Stakeholders, Business teams, and IT Teams

Job Details

  • Configure and support Ennov RIM modules including submissions, registrations, and product lifecycle management
  • Strong understanding and experience with the Ennov RIM system's capabilities and the underlying Extended Data Objects EDO technology.
  • Participate in Ennov RIM implementation and migration projects, ensuring system alignment with regulatory processes Provide expert level knowledge of the Ennov RIM system's features, functionality, and configurations for managing regulatory data and processes. Ensure compliance with GxP and support Computer System Validation CSV activities and related documentation
  • Act as liaison between business users and technical teams, providing clear communication and issue resolution Map existing regulatory workflows, propose improvements, and support process optimization initiatives within RIM
  • Excellent communication skills for interacting with clients and internal teams, and the ability to translate technical information into understandable terms.
  • Support the implementation of Ennov RIM solutions, including user training and system configuration to align with client needs. Collaborate with clients to understand their regulatory challenges and help them streamline end to end RIM activities, from product registration to submission management.

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