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 109,000 colleagues serve people in more than 160 countries.

About Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation, and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices, and clinics.

Our location in Lake Forest, Illinois currently has an opportunity for a Program Manager, Clinical Affairs. In this role, you will execute the development and transfer work in collaboration with others for projects. Works within the Operations department to transfer new products from R&D.

WHAT YOU’LL DO:

• Actively lead and / or participate on cross-functional teams; projects are typically large and complex
• Responsible for program management of all clinical studies including activities such as but not limited to:
• Study strategy cost and timelines and outcome too design validation plans
• identification, qualification, and training of investigators
• Prepare protocols and other relevant documentation
• Site visits
• Study monitoring; data analysis appropriate, accurate and timely
• Prepare clinical sections of domestic regulatory submissions and international registration packages
• Support internal customers in preparing responses related to clinical studies
• Prepare and review product labeling and promotional materials
• Initiate publication and presentation of clinical data
• Indicate the reporting relationships, products, budgets, throughput, level and purpose of contacts (internal and external), or other scope measures that are key to this position
• Implementation of strategy, scope, process, and programs related to clinical trials
• Providing significant and positive impact to short-term, mid-range, and long-term organizational goals
• Demonstrating continual improvement in product / system development related matters
• Creating a work environment that supports cross-functional team effectiveness
• Management and development of reporting staff
• Budgetary responsibilities
• Demonstrated appropriate level of leadership experience to lead and influence; requires high levels of competence, confidence, and credibility;
• Strategic and tactical decisions will be made based upon data the individual provides and/or presents in management or informal setting; errors or failure to achieve results will add costs and may impact the goals of the organization

WHAT YOU’LL BRING

Required:

• Bachelor's degree required
• Exposure in a technical / clinical environment with 8+ years of experience
• Experience in audit/ inspections
• Experience with the design and usage; scientific, regulatory, and compliance requirements of clinical research
• Understanding of clinical laboratory, assay / instrument principles involving in-vitro diagnostic product

Preferred:

• Advanced degree preferred (medical technology (MT)) or certification as a clinical research associate (CCRA)

WHAT WE OFFER:

At Abbott, you can have a good job that can grow into a great career.

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives, and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and a history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott ,and on Twitter @AbbottNews and @AbbottGlobal.