Senior Specialist – Regulatory Submissions Management
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Job Description
Senior Publishing Specialist providing regulatory submission publishing services for GE HealthCare. Ensuring quality and timeliness while liaising with Regulatory Affairs and local affiliates.
Responsibilities:
- 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
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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