Publishing Intern, Regulatory Submissions Management - Chalfont Saint Giles, United Kingdom - GE Healthcare

Tom O´Connor

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Description

Job Description Summary:

As a Publishing Intern 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.


Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams.

Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.


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 handson 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 submissionready document standards
  • Support projects related to improving the publishing tools, standards, and processes
  • Monitor agency guidance & changing regulations in assigned region

Qualifications and Experience:


  • A Level/equivalent education or relevant work experience

Desirable Skills:


  • Familiarity with Excel/Word/Adobe Acrobat packages
  • Experience with Electronic Document Management Systems
  • Good interpersonal skills and ability to engage effectively with peers
  • Ability to resolve most daytoday 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 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.

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Additional Information:


Relocation Assistance Provided:
No

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