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Associate Systems Analyst - docuBridge - Remote

Posted 2 days ago
DevOps / Sysadmin
Full Time
Worldwide

Overview

The Associate Systems Analyst - DocuBridge plays a key role in the implementation and lifecycle management of structured regulatory submission solutions, focusing on Lorenz DocuBridge, ensuring compliance with global and regional regulatory requirements.

In Short

  • Implement and manage regulatory submission solutions.
  • Collaborate with internal and vendor teams.
  • Assist in validation testing and user experience optimization.
  • Support project planning and execution.
  • Develop validation plans and related documentation.
  • Ensure regulatory submission readiness.
  • Monitor production performance and resolve issues.
  • Conduct user training and develop training materials.
  • Work with ITIL standards for change control.
  • Manage user access controls and system integrity.

Requirements

  • Bachelor’s degree and 2 to 6 years of experience.
  • Experience with Lorenz DocuBridge.
  • Knowledge of SDLC and requirements gathering.
  • Familiarity with relational databases and SQL.
  • Understanding of programming languages like Java or Python.
  • Experience with cloud services such as AWS.
  • Knowledge of GxP compliance and FDA regulations.
  • SAFe® for Teams certification is preferred.
  • Excellent analytical and problem-solving skills.
  • Ability to work effectively in global teams.

Benefits

  • Competitive salary and comprehensive Total Rewards Plans.
  • Collaborative and innovative work culture.
  • Support for professional and personal growth.
  • Opportunities to make a lasting impact in healthcare.
  • Inclusive environment respecting diversity.
Amgen logo

Amgen

1074 Amgen Technology Pvt Ltd. is a leading biotechnology company dedicated to improving the quality of life for patients suffering from serious illnesses. Since its inception in 1980, Amgen has pioneered advancements in biotech, focusing on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. The company is committed to discovering, developing, manufacturing, and delivering innovative human therapeutics, leveraging advanced human genetics to address complex diseases. With a collaborative and science-based culture, Amgen strives to make a lasting impact on patients' lives while fostering an inclusive environment for its diverse workforce. As a global leader in biotechnology, Amgen continues to develop a pipeline of medicines aimed at addressing high unmet medical needs and improving health outcomes worldwide.

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