Senior Clinical Specialist, Medical Affairs

3 weeks ago

Lake Forest, United States ICU Medical Inc. Full time

Position Summary

The Senior Clinical Specialist (RN) provides clinical support to internal and external customers and provide the voice of the customer and to serve as subject matter expert on use and applicability of products. The primary function of the Senior Clinical Specialist is to support the development of new and existing products for ICU Medical, Inc.

Essential Duties & Responsibilities

* Provide Medical and Human Factors support to Core Teams for the assigned products
* Serve as Subject Matter Expert on use and applicability of products
* Assimilate voice of 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
* Provide support in answering on-label and off-label medical information inquires internally and externally
* Provide Medical input in the development and execution 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)
* Coordinate and execute Human Factors activities including study design, protocol and report generation. Coordinate activities with 3rd party vendors
* Train, mentor, and develop team members
* Provide clinical and developmental support for customer escalations
* Work on special projects/assignments/activities as they arise
* Assumes other duties and responsibilities as assigned by manager/supervisor

Knowledge, Skills & Qualifications

* Ability to effectively apply clinical knowledge base to responsibilities of position
* Ability to manage multiple assignments, makes timely decisions, communicates concerns and self-motivated
* Ability to assimilate information, adapt to challenges and incorporate new subject matter
* Bring a creative mind-set and innovative approach
* Negotiate skillfully in tough situations with both internal, including higher levels, and external groups.
* Able to complete an in-depth analysis of the work process and be able to evaluate process effectiveness and compliance.
* 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
* Knowledge of and the ability to analyze complex documents and guidelines to inform corporate clinical decision making
* Strong project management skills and ability to manage multiple projects simultaneously
* Collaborative leadership skills and able to lead and influence without authority
* Interact with a broad range of customers, internal/external and business/medical, utilizing highly developed verbal and written 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

* Bachelor's degree from an accredited college or university
* Registered Nurse Licensure in a U.S. state or territory in good standing
* Minimum 7 years experience in medical device industry
* Minimum 5 years of clinical experience

Minimum Qualifications

* Must be at least 18 years of age

Travel Requirements

* Typically requires travel 5-20% of the time

Physical Requirements and Work Environment

* This is largely a sedentary role.
* This job operates in a professional office environment and routinely uses standard office equipment.

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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