Medical Affairs Specialist
JR100523
Site: Mexico City
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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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.
Overview:
Provide support to Medical Affairs (MA) management and Medical Monitors in all aspects of MA activities, as needed
Assist in providing medical/scientific consultation to internal and external customers with oversight from the medical monitor (MM) Ensure that daily medical management activities are completed in accordance with ICON
standards and other applicable standards
Responsibilities:
The role:
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Travel ( less than 10%) domestic and/or international
• *Serve as an integral part of the MA team
• *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
Qualifications:
You will need:
• A Minimum of 2 years of experience of relevant clinical research industry experience
• Degree in Health
• Basic knowledge of medical terminology and coding systems
• Advanced English for Reading, Writing and Speaking
• Excellent written and verbal communication
- Advanced Office Pack
- Desirable experience in Pharma
- Knowledge of ICH guidelines
Note: Hybrid Position: 2 days at home, 3 days at the office
To be successful in the role, you will have:
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
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