Clinical Specialist II, Medical Affairs

7 days ago


Lake Forest, California, United States ICU Medical Full time
Job Summary

We are seeking a highly skilled Clinical Specialist II to join our Medical Affairs team at ICU Medical. This role will provide clinical support to internal and external customers, and serve as a clinical expert on the use and applicability of our products.

Key Responsibilities
  • Provide medical and clinical support to core teams for assigned products
  • Serve as a clinical expert on the use and applicability of products
  • Assimilate the voice of the customer and clinical experience for design input with new product development and product lifecycle management
  • Provide medical opinion and usability in the development and design of new and existing products
  • Support in answering on-label and off-label medical information inquiries internally and externally
  • Provide medical input in the development of product labeling
  • Provide clinical input for on-market product issues per industry standards via post-market risk assessments
  • Assist in the development of clinical literature that can demonstrate the clinical advantages of ICU Medical's products
  • Provide clinical input for Clinical Evaluation Reports (CER's)
Requirements
  • Ability to effectively apply clinical knowledge base to responsibilities of position
  • Ability to manage multiple assignments, make timely decisions, communicate concerns and self-motivated
  • Ability to assimilate information, adapt to challenges and incorporate new subject matter
  • Bring a creative mindset and innovative approach
  • Negotiate skillfully in tough situations with both internal, including higher levels, and external groups
  • Organization, prioritization and familiarity with working in a regulated industry setting
  • Ability to consistently meet deadlines despite high volume
  • Strong communication skills and attention to detail with ability to multi-task
  • Ability to define problems, collect data, establish facts, draw valid conclusions and present to management
  • Strong project management skills and ability to manage multiple projects simultaneously
  • Collaborative leadership skills and able to lead and influence without authority
  • Excellent written and verbal communication skills
  • Excellent interpersonal skills and teamwork oriented
  • Self-motivated and skilled at working independently
  • Strong comprehension and communication skills (verbal and written)
  • Proficiency in Microsoft office including Word, Excel, Power Point and Outlook
  • Advanced computer skills required: MS Word, MS Excel, PowerPoint, MS Project and SQL/Database management tools
  • Excellent Presentation Skills, ability to make effective presentations to all levels of management
  • Must be self-motivated, well-organized with the ability to work under time-sensitive deadlines
Education and Experience
  • Must be at least 18 years of age
  • Bachelor's degree from an accredited college or university
  • Registered Nurse Licensure in a U.S. state or territory in good standing
  • Minimum 2 years experience required, preferable in medical device industry
  • Minimum 5 years of clinical experience
Work Environment

This is a largely sedentary role. The job operates in a professional office environment and routinely uses standard office equipment. Typically requires travel 5-10% of the time.



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