Senior Manager, 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 Maple Grove, MN currently has an on-site opportunity for a Senior Manager, Clinical Safety professional.  Along with their team, the Senior Manager provides oversight of medical device safety performance, oversight in the development and maintenance of project-specific safety plans, WIs, and SOPs related to safety, and ensures required regulatory reporting requirements are met. Responsible for leadership and development of staff.

What You’ll Work On

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures as well as all laws, guidelines and regulations applicable for clinical safety reporting.
• Leads all safety activities for at least one product portfolio including assigned direct reports within that portfolio.
• Provide strategic leadership and subject matter expertise for safety of the medical devices used in the clinical trials.
• Works cross-functionally to implement relevant guidelines into Abbott practices and procedures.
• Oversight of the personnel 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.
• 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.
• May have budgetary responsibility for cost center or safety activity in a clinical program.
• Management of team development, mentoring and effective delegation to direct reports to meet program
• Effectively communicate information through the planning and execution of meetings and presentations and Present recommendations to leaders.
• Participates in strategy development and execution for specified clinical area.
• Effective coordination of all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.
• Anticipate potential problems within a clinical program and create contingency plans accordingly.
• Elevate potential changes in regulatory or clinical environment to leadership
• Manage performance management process for the team.
• Prioritization across teams to ensure strategic goals/milestones are met