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Medical Affairs Specialist

Poland-Warsaw
Permanent
Reference: 047454
Description
Medical Affairs Specialist
 
Provide support to Medical Affairs 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
 
Role
  • 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
  • Liaise with safety and regulatory teams in order to facilitate open communication regarding updates on SAEs and regulatory issues
  • Review and demonstrate working knowledge of contract and GPT in conjunction with MM
 
Requirements
  • Bachelor's Degree or local equivalent Medical or Health-Science background (nursing preferred
  • EU prior relevant clinical research experience
  • Demonstrates professional demeanour, judgment , and discernment in interactions with colleagues, clients and other ICON staff
  • High level of flexibility and ability to prioritize one's own work and others as it relates to the overall processes
  • Good organizational skills
  • Good communication skills, written and oral
  • Elementary presentation skills
  • Basic knowledge of medical terminology and coding systems
  • Attention to detail and ability to demonstrate critical thinking
  • Show initiative and the ability to work within team environment
  • Ability to analyze data in a broader context as it applies to the review of clinical trial data (laboratory values, eCRF, listings, coding) with guidance from Sr. MA Specialist, MA Coordinator
  • Willingness to work effectively across multiple therapeutic areas and functions within MA
  • Fluent English verbal and written communications
  • Working knowledge of applicable global, regional and local regulatory requirements
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