Specialist - Regulatory Submissions Management

Title: Specialist - Regulatory Submissions Management

Location: Remote7

locations

Remote

time type

Full time

Job Description:

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 

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $62,400.00-$93,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

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