Senior Specialist - Regulatory Submissions Management

GE HealthCare

3d•$73,600 - $110,400•Hybrid

About The Position

As a Senior Publishing Specialist within the Regulatory Submissions Management team, you will be responsible for providing regulatory submission publishing services in an efficient and timely manner. This role is a key point of contact for all customers of the Regulatory Operations group; and upholds “right first time” submission quality and timeliness. Your work will perform a pivotal role in achieving GE HealthCare’s Regulatory Strategies.

Requirements

2+ years of Submission Publishing and Submission Management principles, with good knowledge of formats, standards, and processes in your assigned region
Hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault)
Good proficiency in spoken and written English
Willing to attend local GE Healthcare office on an ‘as-needed’ basis
Willing to travel when required, but not more than 5%

Nice To Haves

Good interpersonal skills and ability to engage effectively with peers
Ability to resolve day-to-day issues, escalating to peers and/or supervisors as needed
Good IT skills, with the ability to learn new tools and systems quickly
Experience working with outsource partners an advantage

Responsibilities

Use Veeva for Registrations to plan and track your assigned submissions and effectively manage own workload
Liaise with Regulatory Affairs and local affiliates to provide them with Submissions Management and hands-on Submissions Publishing support
Work with Regulatory Submissions Management counterparts in other regions to facilitate global worksharing
Provide customers with best practice guidance within Submission Publishing, Document Management (using Veeva Vault) and submission-ready document standards
Provide guidance to junior staff members as needed
Support projects related to improving the publishing tools, standards, and processes
Monitor agency guidance & changing regulations in assigned region