About the Role

We are looking for a Patient Safety Specialist to join our Office of Medical Affairs team. In this role, you will provide healthcare provider perspective, medical expertise and judgment, and objectivity in review of patient and medical device safety matters and act as an independent patient safety advocate for all products within a product category. 

This is a remote position, and you can work from home in most locations within the United States. 

Responsibilities

• Process participant for pre- and post-market safety activities, including risk management, clinical study adverse event review, product launches, product surveillance, and quality investigations
• Provide healthcare provider perspective on benefit / risk questions.
• Ensure appropriate and adequate assessment and disclosure of medical risk.
• Ensure accurate and balanced presentation of human clinical data from a medical perspective including in regulatory reporting efforts and promotional materials
• Provide medical judgment to assist in select regulatory, clinical investigation, compliance, or legal matters.
• Serve as a reviewing and refining resource and provide in-depth and compositional support as needed while ensuring proposed changes adequately address clinical considerations.
• Establishing functional expertise and serving as subject-matter expert for safety processes 
• Maintain compliance with training expectations as required for this position
• Additional responsibilities as required within the scope of position

Required Qualifications

• Training or experience as a healthcare provider (RN, PA, DO, MD)
• Experience with pharma or medical device safety activities
• Medical or scientific writing experience
• Ability to influence with knowledge and consensus building in a cross-functional environment
• Ability to analyze, integrate, and interpret data from multiple primary safety information sources
• Ability to travel up to 10%

Desired Qualifications

• Experience in vascular or cardiac interventional therapies
• Experience with quality management system
• Familiarity with: Clinical trial Adverse Event process (EDC systems, MedDRA coding, ISO 14155), Product surveillance process (MDR, 21 CFR 803), Documents submitted to global regulatory bodies (FDA and EU MDR), Risk management process (hazard analysis, HHE, CER, fMEA, IFU), Medical, Legal, Regulatory (MLR) process (review of marketing materials)

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island