Sobre este puesto de Specialist - Regulatory Submissions Management en GE HealthCare
Job Description Summary
As a 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.Job Description
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 work-sharing
Provide customers with best practice guidance within Submission Publishing, Document Management (using Veeva Vault) and submission-ready document standards
Support projects related to improving the publishing tools, standards, and processes
Monitor agency guidance & changing regulations in assigned region
Required Qualifications:
1+ year of Submission Publishing and Submission Management principles is preferred, with some knowledge of formats, standards, and processes in your assigned region
Some hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault) an advantage
Desirable Skills:
Good interpersonal skills and ability to engage effectively with peers
Ability to resolve most 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
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No