Associate Director, Global Clinical Safety - Medical Devices (on-site)

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

Our location in Santa Clara, CA or Maple Grove, MN currently has an on-site opportunity for an Associate Director, Clinical Safety professional.  Reporting to the Global Safety Director, this position will provide leadership, management, and direction for Clinical Safety for Abbott’s clinical trials. This new team member is responsible for oversight of medical device safety performance, oversight in the development and maintenance of project-specific Safety Plans, Abbott Standard Operating Procedures (SOPs) and Work Instructions related to safety, and ensuring required regulatory reporting requirements are met.

What You’ll Work On

• Directs all activities related to safety components of Abbott’s clinical trials.
• Accountable for Safety support of up to 3 business units and their associated product portfolios.
• Provide strategic leadership and subject matter expertise for safety of the medical devices used in the clinical studies.
• Work cross functionally to implement relevant guidelines into Abbott practices and procedures.
• Oversight of the staff that perform the day-to-day clinical trial adverse event processing function and serious adverse events reporting to regulatory agencies following the company policies and applicable US and international regulations.
• Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
• In collaboration with Clinical Science and Project Management, contribute to or review regulatory and clinical documents including Clinical Reports, Informed Consent Forms, pre-market submission documents, and responses to regulatory authority inquiries.
• Provide support and review study-specific documents for clinical trials including CIP, safety-related case report forms, and design of tables and listings for safety data from clinical studies to present to independent committees.
• Understand the legal and compliance environment and drive collaboration with the Clinical Quality & Compliance team.
• Undertake activities to maintain a state of inspection readiness and participate in audits, including being the representative and point of contact for inspections by regulatory authorities and internal audit requests/questions rela