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Senior Associate Data Management - Remote

Posted 2 days ago
Data Analysis
Full Time
India

Overview

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements.

In Short

  • Maintain data within the Regulatory Information Management (RIM) system.
  • Create and archive clinical trial and marketing application submissions.
  • Serve as a Data Management SME in collaborative initiatives.
  • Implement new processes within Veeva Vault and other key regulatory initiatives.
  • Support on creating, running and analysing reports for data streamline projects.
  • Develop and deliver training materials and presentations globally.
  • Manage protocol Amendment New Investigator submission updates.
  • Provide support on US and EU Certificate of Pharmaceutical Product.
  • Adhere to processes, policies, guidelines, and training documentation.
  • Work well with others and demonstrate critical thinking skills.

Requirements

  • Familiarity with Global Clinical Trial Applications and Regulations.
  • In-depth understanding of the Veeva Vault system.
  • Good written and verbal communication skills.
  • Detail-oriented with independent time management skills.
  • Ability to work efficiently with minimal supervision.
  • Strong analytical and problem-solving skills.
  • Experience in supporting projects and improvement initiatives.
  • Fluent in English, both oral and written.
  • Master’s degree or equivalent experience preferred.
  • Advanced knowledge of Veeva Vault RIM preferred.

Benefits

  • Opportunity to work in a dynamic environment.
  • Engagement in innovative projects in biotechnology.
  • Collaboration with global teams.
  • Professional development through training.
  • Contributing to significant health outcomes.
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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