Clinical Specialist II, Medical Affairs
7 days ago
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)
- 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
- 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
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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Lake Forest, California, United States ICU Medical Full timeJob SummaryThis 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 ResponsibilitiesProvide medical and clinical support to core teams...
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