Senior Specialist - Regulatory Submissions Management

3w3 weeks ago

GE HealthCare

US · Full-time · $73,600 – $110,400

About this role

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.

You will use Veeva for Registrations to plan and track your assigned submissions and effectively manage your own workload. You will liaise with Regulatory Affairs and local affiliates to provide submissions management and hands-on publishing support, while also working with global counterparts to facilitate worksharing.

You will provide customers with best practice guidance within submission publishing and document management using Veeva Vault. You will also provide guidance to junior staff members as needed and support projects to improve publishing tools, standards, and processes.

Your work performs a pivotal role in achieving GE HealthCare’s Regulatory Strategies, ensuring efficient and timely submissions. This position offers the opportunity to work with cutting-edge Veeva platforms and contribute to global regulatory operations.

Requirements

Minimum 2 years of experience in Submission Publishing and Submission Management principles, with good knowledge of formats, standards, and processes in the 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 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 ability to learn new tools and systems quickly.
Good proficiency in spoken and written English.
Willingness to attend local GE HealthCare office on an as-needed basis and travel when required (up to 5%).

Responsibilities

Plan and track assigned submissions using Veeva for Registrations and manage your own workload effectively.
Liaise with Regulatory Affairs and local affiliates to provide 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 publishing tools, standards, and processes.
Monitor agency guidance and changing regulations in the assigned region.

Benefits

Performance-based incentive compensation including cash bonuses and long-term incentives (LTI).
Competitive benefits package including medical, dental, vision, and paid time off.
401(k) plan with employee and company contribution opportunities.
Life, disability, and accident insurance.
Tuition reimbursement.
Professional development and challenging career opportunities.