O pozici
The Advisor for Global Medical Affairs is a key strategic partner responsible for bringing clinical insights and strategic direction to pre-and post-market products enabling growth opportunities, strengthening product quality and customer satisfaction for Cardinal Health™ brand and Presource product categories. This role will also be responsible for providing medical and clinical expertise throughout the product lifecycle for Cardinal Health’s Global Medical Products and Distribution to strengthen clinical solutions.
Co budeš dělat
- Provides clinical expertise and serves as subject matter expert to support product design , change management, and risk mitigation throughout product lifecycle management.
- Serve as a clinical consultant and aligns clinical practice, product usage and user need to support, Marketing, Sales, Clinical Affairs, Research & Development, Biocompatibility, Sterility, Quality, Design Quality, Regulatory, and Post Market Surveillance.
- Partner with marketing to align clinical insights with product portfolio strategy and key priorities.
- Engage with key cross functional leaders to align claims, and instructions for use, with internal and external clinical education needs throughout product lifecycle.
- Provide medical expertise to identify potential risk to health and support patient safety through risk assessment, and appropriate correspondences regarding adverse events to the FDA, and other global competent authorities and regulators.
- Serve as expert reviewer for European and Canadian Medical Device Regulation documents.
- Participate in the development and maintenance of Medical Affairs processes and Standard Operating Procedures.
- Provide insight into the health economics and reimbursement landscapes to provide direction on product portfolio strategy and key priorities.
- Prepare and deliver quality focused presentations, complaint analyses, Voice of Customer (VOC) summaries, and performance updates for internal leadership and external customers.
- Participate in customer audits, business reviews, and supplier quality discussions to represent Presource’s product and process quality.
- Support new product launches, transitions, or manufacturing changes that impact customers, ensuring effective communication and alignment across teams.
- Maintain up to date knowledge of operational quality activities, product functionality, kit configuration, and process controls related to improving kit performance.
- Provides coaching and mentorship on quality best practices and customer focused behaviors.
- Monitor and help manage the Presource Quality Customer Support inbox, ensuring timely, accurate, and professional communication.
Koho hledáme
- Minimum of five (5) years of clinical nursing involving direct patient care, in Operating Room (OR), Perioperative Care Unit, preferred.
- Bachelor’s degree in nursing or equivalent work experience, preferred. Advanced Practice Nurse or Master’s level degree with active nursing license a plus.
- Knowledge and/or experience in quality improvement and patient safety across the care continuum, preferred.
- Experience in the medical device industry, preferred.
- Ability to assess clinical outcomes, analyze data, summarize, and present findings preferred.
- Ability to perform comprehensive literature reviews, preferred.
- Proficient in Microsoft Office applications, including Excel, Word and PowerPoint, preferred.
- Excellent written and oral English communication skills, preferred.
- Project management skills, preferred.
- Solid understanding of customer‑focused strategies and Voice of Customer (VOC) methodologies, preferred.
- Ability to travel up to 25% based on business need.
Benefity
- Medical, dental and vision coverage
- Paid time off plan
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
