Medical Affairs Specialist
About the role
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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.
ICON is looking for a Medical Affairs Specialist to provide support for the Medical Affairs management and Medical Monitors in all aspects of MA activities.
- Demonstrate relevant protocol and product knowledge of assigned protocols with oversight and guidance from the Medical Monitor
- Author and contribute to the preparation of core MA internal and external deliverables (MMPs, trackers, reports) as contracted
- Provide functional oversight for MA as directed by lead MM for specific studies
- Recognize potential issues relevant for MA project tasks and escalate according to the applicable procedure
- Provide input and review of relevant MA tracking systems for accuracy and quality and assist with maintaining MA project files
- Perform review of clinical and diagnostic data with oversight from the MM as it relates to patient safety
- Liaise with investigational site and/or Sponsor as necessary regarding MA issues with oversight and guidance from MM
- Participate in internal and external project team meetings and teleconferences,as required
- Serve as a resource for investigational sites and ICON personnel on safety-related issues as they pertain to MA tasks with assistance and oversight from MM as required
- Liaise with ICON project manager, and other departments, as appropriate
- Assist MM with weekly and monthly project status reports
- Contribute to presentations for start-up meetings, Investigator meetings and other meetings as requested
- Liaise with safety and regulatory teams in order to facilitate open communication regarding updates on SAEs and regulatory issues
- Assist with financial oversight of projects (monthly unit metrics, Change Orders, out-of-scope activities and any other financial tracking)
- Review and demonstrate working knowledge of contract and GPT in conjunction with MM
- Coordination of periodic project review meetings
Requirements/Experience/Skills
- Bachelor's degree in nursing preferred with some related experience
- Good communications kills
- Good computer skills (Microsoft Word, Excel, Outlook, PowerPoint, Access)
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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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