ICON Clinical Research Medical Affairs Specialist in Warsaw, Poland

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