Senior Associate, Global Submission Management - International

Lead / support various Clinical Trial and Marketing Application type submissions and associated Global / Submission Content Plans.

• Participation in information system and software update projects as well as ongoing system validations.
• Serve as point of contact between Amgen's functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM.
• Independently remain current on guidance (internal / external) and translate requirements into operational activities.
• Represent departmental expertise on regulatory projects and regional / global workstreams.
• Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective.
• Contribute to the development of the strategy for communicating with global health authorities.
• Initiate, lead, and manage process development and improvement.
• Participation in information system and software update projects as well as ongoing system validations.

Required Knowledge and Skills :

Preferred Knowledge and Skills :

Basic Education and Experience :

Preferred Education and Experience :

Skills Required

ectd, Project Management, Regulatory, information system , Veeva, Regulatory Submissions