Abbott Senior Specialist, Product Performance, Medical Affairs in Santa Clara, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
MAIN PURPOSE OF ROLE
Specialist professional individual contributor with comprehensive knowledge in the area of Medical Affairs.
Ability to execute highly complex or specialized projects.
Adapts precedent and may make significant departures from traditional approaches to develop solutions
•As the Specialist in the Medical Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in overseeing the direction, planning, execution, clinical trials/research and product quality/safety activities.
•Coordinates and provides reporting information for reports submitted to the regulatory agencies.
•Under Medical Advisor and Director oversight, provide medical oversight for on-market product and product
performance functions, including monitoring of product safety related items (i.e. complaints, MDRs),
reporting, evaluation, and Health Hazard Evaluations and safety in clinical study design.
•Reviews and evaluates product performance data and trends to provide early identification of issues
related to product performance or usage concerns in order to minimize clinical safety risk. This includes
designing changes to product performance assessment and management to improve ongoing monitoring
and risk assessment.
•Makes appropriate product and procedural recommendations, and works closely with doctor/patient
related issues for the safety of drug eluting stents, coronary, endovascular and clinical study activities
•Works cross functionally with division Compliance, Clinical Science, Regulatory Affairs, and Commercial organizations as required. Requires involvement with all on-market product performance, clinical product performance,
compliance, clinical, clinical science, medical information, scientific, and regulatory groups within Abbott.
•Establish medical and scientific information for Abbott products and products in development, and ensure that medical information is of high quality and communicated in an accurate, balanced, timely and compliant way.
•Be accountable for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
Degree in Pharmacy, Nursing, RT, Life Science, or other health-related field, or equivalent qualification
Minimum 7 years experience. A background in cardiology, cardiac surgery or vascular medicine/surgery is preferred.
Experience working in a quality related role, or equivalent time in clinical laboratory, medical clinic, or nursing experience.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com