Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Field Product Specialist II at Cook MyoSite Inc. supports clinical trial procedures through direct physician and site interaction, education, and procedural observation. Builds relationships, provides feedback and solutions for program development, identifies opportunities to improve compliance with protocols/procedures, and shares best practices. Assists with patient recruitment efforts. Collaborates with internal depts such as but not limited to, Clinical Affairs, Clinical Safety, Clinical Science, Marketing, Product Management. Frequent interactions and collaboration with CROs.
• Creates summaries of findings during clinical trial procedures
• Educates clinicians domestically and internationally on the product, procedures, and MyoSite processes
• Identifies, supports, and develops relationships with key clinical and non-clinical decision-makers
• Analyzes patient recruitment needs and creates marketing plans for sites
• Provides feedback to Clinical Development, Product Management, and other internal groups
• Supports new study or product launches, including assisting with creation of training materials/programs, presentations, and ongoing field support
• Supports clinical evaluations and trials
• Maintains appropriate communication with Clinical Affairs Manager, Clinical Affairs department, Product Management, Marketing, and the CROs
• Understands the rules and regulations associated with cGCP and cGMP
• Maintains accurate and timely reports and records
• Assists with physician training events and internal procedure workshops
• Travels to domestic and international professional meetings as a representative of Cook MyoSite
• Assists with Investigator Meeting planning
• Undergraduate degree in natural science, nursing, or 3 years direct, relevant experience in healthcare field as a medical sales representative, clinical specialist, or nurse to provide a comparable background
• Minimum of 3-6 years' experience in medical sales or healthcare setting and experience providing procedural support in hospitals or clinic settings
• Proficient knowledge of Microsoft Office software, and other general office equipment
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations
• Must demonstrate a sense of urgency and being proactive to avoid material shortages
• Setting (Remote/Field Based): General office or home office setting
• Travel (Domestic & International): 50-75%
• Driver's license & passport required
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.