AtriCure
Published
09/07/2021
Location
7555 Innovation Way, Mason OH 45050, Mason
Category
Job Type
Contact Name
Rebecca Sloneker

Description

*Remote position with travel to Minneapolis, MN Office as required.

*Company Headquarters in Mason, OH

REPORTS TO: VP, Global Scientific Affairs and Evidence Strategy

POSITION SUMMARY:

The position is responsible for supporting the development of the evidence strategy in alignment with the strategic goals of the company by interacting with the cross-functional leaders in Marketing, R&D, Scientific, Medical, Regulatory and Clinical affairs and thought leaders. The position will design clinical trials (IDE, post-market) and assess the design of investigator-initiated research proposals, as necessary.

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Engage with the cross-functional leaders in Marketing, R&D, Scientific, Clinical, Regulatory and Medical Affairs departments to support the development of evidence strategy and roadmaps
  • Participate in early stages of product development to determine the clinical evidence needed for product approval / indication expansion.
  • Create clinical study synopsis based on the evidence needs and in collaboration with the thought leaders
  • Support FDA pre-submission, response to the IDE deficiencies and study design considerations and questions following PMA submissions in collaboration with the cross functional team
  • Provide scientific voice, perspective and accuracy for company initiatives
  • Maintain credibility by being on the leading edge on state of science and shifts in clinical and treatment paradigms
  • Perform other duties as needed or assigned.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance
  • Ability to work under fast-paced conditions
  • Ability to make decisions and use good judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assigned

BASIC QUALIFICATIONS:

  • Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
  • 10+ years of clinical, regulatory, scientific or medical affairs experience in a medical device manufacturing environment
  • Knowledge of theories, principles, and concepts of cardiac arrhythmia in the context of device therapy, electrophysiology and surgical medicine.
  • Knowledge of clinical study design principals and pertinent FDA and International regulatory guidelines
  • Thoughtful, energetic individual with the ability to communicate the scientific strategy to internal and external audience
  • Excellent written and oral communicator and strategic thinker capable of communicating clearly to a variety of audiences worldwide. Ability to synthesize information from scientific/medical literature and communicate responses to complex questions in scientific and layperson’s terms
  • Demonstrated ability to effectively manage multiple projects at varying stages of development under time and resource pressure
  • Ability to work independently, as part of a team and manage a team.
  • Effective interpersonal skills/diplomacy and problem-solving techniques
  • Proficient computer skills; able to use standardized office software products, ie., Microsoft Word, Excel, PowerPoint, etc.
  • Ability to travel 20-30%

PREFERRED QUALIFICATIONS:

  • A PhD with experience in atrial fibrillation research

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pull
  • Ability to occasionally lift up to 25 pounds
  • Ability to pass pre-employment drug screen and background check

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