Senior Document Coordinator

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Job Title: Senior Document Coordinator

Genmab seeks an experienced Senior Document Coordinator to manage submissions, collaborate with cross-functional teams, and drive timely delivery of submission documents.

About the Role
  • Manage submission process to ensure compliance and accuracy
  • Develop and maintain relationships with project managers, regulatory leaders, and content authors to facilitate submission preparation
  • Represent Regulatory Operations on project teams to drive project goals and objectives

The ideal candidate will have a proven track record of success in Regulatory Operations, excellent communication and leadership skills, and in-depth knowledge of regulatory requirements and industry standards. You will report to the Senior Director of Global Regulatory Affairs, Operations.

Responsibilities
  • Ensure regulatory compliance and accuracy of submission documents
  • Develop and implement procedures for submission management
  • Collaborate with cross-functional teams to drive project goals and objectives
Requirements
  • Minimum 5 years pharmaceutical industry experience, with a focus on Regulatory Operations
  • BA/BS degree or equivalent and knowledge of MAA/BLA/IND requirements and guidelines
  • Proficiency with MS-Office Suite and Adobe Acrobat application
About Genmab

Genmab is a global biotechnology company dedicated to developing innovative treatments for patients with high unmet medical needs. We strive to be at the forefront of innovation, leveraging cutting-edge technologies to create life-changing treatments.



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