Senior Specialist – Regulatory Submissions Management
Location
United States
Posted
11 days ago
Salary
$73.6K - $110.4K / year
Seniority
Senior
Job Description
Senior Specialist – Regulatory Submissions Management
GE HealthCare
• provide regulatory submission publishing services in an efficient and timely manner • key point of contact for all customers of the Regulatory Operations group • uphold “right first time” submission quality and timeliness • liaison with Regulatory Affairs and local affiliates for support • work with counterparts in other regions to facilitate global worksharing • provide best practice guidance within Submission Publishing and Document Management • provide guidance to junior staff members • support projects related to improving publishing tools, standards, and processes • monitor agency guidance & changing regulations in assigned region
Job Requirements
- 2+ years of Submission Publishing and Submission Management principles
- good knowledge of formats, standards, and processes
- hands-on experience with Submission Publishing
- Validation and PDF manipulation software
- Document Management and RIM systems (e.g., Veeva Vault)
- good interpersonal skills
- ability to engage effectively with peers
- ability to resolve day-to-day issues
- good IT skills, with the ability to learn new tools and systems quickly
- experience working with outsource partners an advantage
- 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%
Benefits
- medical
- dental
- vision
- paid time off
- a 401(k) plan with employee and company contribution opportunities
- life
- disability
- accident insurance
- tuition reimbursement
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