Clinical Specialist II, Medical Affairs Professional

2 days ago

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

This role is responsible for providing clinical support to internal and external customers, serving as a clinical expert on product use and applicability, and assimilating the voice of the customer for design input with new product development and product lifecycle management.

Key Responsibilities
  • Provide medical and clinical support to core teams for assigned products
  • Serve as a clinical expert on product use and applicability
  • Assimilate the voice of the customer 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 demonstrates the clinical advantages of ICU Medical's products
  • Provide clinical input for Clinical Evaluation Reports (CERs)
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 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, PowerPoint, 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
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 of experience required, preferably in the 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.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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