Medical Affairs Specialist

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 or MM

•     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