Publishing Specialist
Há 8 horas
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
The role:
The publishing of documents and/or submissions in accordance with the applicable regulations and guidelines; as well as sponsor-specific requirements when provided.
**Responsibilities**:
- Publish clinical summary reports, protocols, case report forms and other documents in accordance to the applicable FDA, ICH and required sponsor specifications for delivery to sponsor.
- *Publish paper and/or fully electronic regulatory submissions to FDA and other countries/regulatory agencies in accordance to the applicable FDA, ICH and required sponsor specifications as contracted.
- *Assist with the remediation of word documents to ensure proper format and compliance with applicable guidance documents.
- *Develop working knowledge of applicable FDA and ICH guidelines related to electronic and paper submissions.
- *Liaise with Project Managers within and external to ICON to gather and share information within the publishing team appointed for each project.
- *Troubleshoot publishing software and document issues
- *Proactively manage publishing projects to assist the project team in meeting contractual agreements and established deadlines and ensure quality.
- Identify potential submission problem areas and/or project related regulatory compliance issues
- Evaluate new software publishing solutions as they become available on the market
- *Share experiences and ideas with team to assist in the further development of the group.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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