Senior Associate Data Management

The Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations.

You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of high-quality regulatory information.

As a subject matter expert in Veeva RIM Vault, you will collaborate with cross-functional teams to guide regulatory initiatives, ensuring the smooth adoption of new processes and system use.

You will also play a key role in training and developing data standards, ensuring teams are equipped to meet the evolving demands of the regulatory landscape.

Your expertise will help shape the future of regulatory operations by streamlining processes and driving compliance across global markets.

Roles & Responsibilities :

• Responsible for maintaining data within the Regulatory Information Management (RIM) system.
• Create and archive clinical trial, marketing application submissions, and health authority correspondence within Amgen's RIM system.
• Serve as a Data Management SME within cross-functional collaborative initiatives.
• Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP, and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives.
• Provide support on creating, running, and analyzing reports for data streamline projects.
• Develop and deliver training materials and presentations to a global audience.
• Manage the protocol Amendment New Investigator (PANI) submission updates.
• Manage 1572 forms for FDA submission.
• Provide support within the global data management team on the US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods.
• Adhere to Amgen processes, policies, guidelines, SOPs, and training documentations.

Required Knowledge and Skills :

Preferred Knowledge and Skills :

Basic Education and Experience :

Preferred Education and Experience :

Skills Required

Data Management, ectd, Project Management, Information Management