Senior Associate, Global Submission Management - Americas

Roles & Responsibilities :

• 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 :

Master's degree and 3-4 years of directly related experience

OR

Bachelor's degree and 4-6 years of directly related experience

OR

Associate's degree and 6-8 years of directly related experience

OR

High school diploma / GED and 8+ years of directly related experience

Preferred Education and Experience :

Practical experience with submission requirements for US, Canada and South America

Skills Required

Rim, Regulatory, Project Management, Management