Senior Specialist, Product Performance, Medical Affairs

Sr. Specialist Clinical Product Performance

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 115,000 colleagues serve people in more than 160 countries.

The Opportunity

We are seeking a Sr. Specialist Clinical Product Performance to work out of our Temecula, CA or Santa Clara, CA location for our Abbott Vascular division. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Specialist professional individual contributor with comprehensive knowledge in the area of medical or clinical interventional therapies. Provides daily business operations support to cross-functional teams as part of the Clinical Product Performance. Ability to execute highly complex or specialized projects. Provides assistance to ensure development of a strategy for the division's medical oversight product performance function.

What You'll Work On

• Daily responsibility/scope for on-market product and clinical study product performance, including post-market clinical data from commercial use of products.
• As the Clinical Specialist in the Quality and Product Performance 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.
• Reports to Associate Medical Director. Provides oversight for on-market product and product performance functions, including monitoring of product safety related items (i.e. complaints, MDRs), reporting, evaluation, and safety in post-market and clinical trials.
• 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
• Analyzes customer complaints and coordinates with PPG to determine which are regulatory reportable and is a key contact for activities with internal, field, and end use customers.
• Coordinates and provides reporting information for reports submitted to the regulatory agencies as applicable.
• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Investigates complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Serve as key resource in areas of MDR reporting, post-market product experience, and risk management.
• Accountable for understanding compliance requirements, risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls.
• Recognizes and reports adverse events and product complaints according to established regulations, DOP's and guidelines.
• Complies medical and scientific information for Abbott products and products in development and ensure that clinical information is of high quality and communicated in an accurate, balanced, timely and compliant way.
• Maintains thorough knowledge of assigned devices, drugs, history, and disease states treated to provide scientifically balanced medical devices and drug information to inquiries on Abbott Vascular products and associated disease states from multiple sources, including telephones, letters, faxes, business reply cards and e-mail from internal and external customers.
• Works cross functionally with division Compliance, Clinical Science, Regulatory Affairs, Medical Affairs and Commercial organizations, as required. Requires involvement with all on-market product performance, product performance, quality compliance, clinical science, medical information, scientific, and regulatory groups within Abbott.

Required Qualifications

• Bachelors Degree in Pharmacy, Nursing, RT, Life Science, or other health-related field, or equivalent qualification
• 5+ years of relevant 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.

Preferred Qualifications

• Highly prefer MD,RN or RT with Cath Lab experience
• Strong ability to work cross functionally, understand various needs across diverse functions, and prioritize work according to business unit needs.
• Experience prioritizing and managing project initiatives across multiple functions and/or business units. Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business model
• Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meets deadlines in timely manner. Strong project management, team skills, and influential management
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Adept at handling multiple assignments in a timely manner and meeting assigned deadlines
• Ability to travel, potentially approximately 10%, including internationally

The base pay for this position is $99,300.00 $198,700.00. In specific locations, the pay range may vary from the range posted.