Summary

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.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Responsibilities: In this role you will:

• 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

Qualifications and Experience:

• 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)

Desirable Skills:

• 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

Eligibility Requirements:

• 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 5-10%

Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership ? always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you?d expect from an organization with global strength and scale, and you?ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. # LI-Hybrid #LI-GM2

Additional Information

Relocation Assistance Provided: No