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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Portland, Maine office, in the Infectious Disease Business Unit. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

An Associate Director at the Medical, Clinical & Scientific Organization (MCSO) at Abbott is a senior-level executive who manages clinical strategy. They work to improve health management by ensuring resources and keeping the clinical department up to date on regulations. 

What You’ll Work On

Support daily business operations for Medical Affairs activities related to product development, aligned with business priorities.

Assist with Medical Affairs activities for on-market product issues, educational inquiries, new technologies, and additional medical information needs.

Provide direction to develop a strategy for the division's medical oversight and product performance functions.

Oversee product and clinical performance functions, including monitoring product safety (e.g., complaints, MDRs), reporting, evaluation, and Health Hazard Evaluations, and ensuring safety in clinical study design.

Under the supervision of the Director, Medical Affairs and/or DVP of Medical Affairs and Product Performance, establish and implement required product safety processes and procedures for new products and technologies as clinical studies are conducted, worldwide regulatory approvals are obtained, and new products are commercialized.

Develop and implement medical affairs strategies, ensuring scientific accuracy in communications, and provide medical support to enhance the company’s product utilization. This role bridges clinical aspects with business strategy to improve patient care and outcomes.

Develop a strong understanding of the infectious disease literature that supports the disease states the assays encompass.

In addition:

Contribute to the global Medical Affairs strategy for the US and Canada in conjunction with MCSO Directors.

Assist Medical Directors in preparing medical platform documents and medical opinions to support product development.

Provide expert opinions regarding laboratory operations, regulations, workflow, and needs.

Build relationships with key opinion leaders and apply their input to enhance study design and protocols.

Engage with healthcare professionals, patients, and stakeholders to understand their needs and perspectives.

Provide references and information to support medical opinions on the safety, efficacy, medical usefulness, and marketability of drug or medical device product candidates or Health Hazard Assessments for on-market product issues.

Develop educational material and be able to teach it in lectures.

Work with the medical community on inquiries they have about disease states or assays.

Collaborate with outside medical groups to improve infectious disease testing.

Provide medical affairs input into design control activities.

Identify and elevate any significant issues under the supervision of the Medical Director.

Provide timely responses to prevent delays in project timelines.

Mentor new personnel and/or direct reports.

Under Director and DVP oversight, provide medical oversight for on-market product and product performance functions, including monitoring product safety (e.g., complaints, MDRs), reporting, evaluation, and Health Hazard Evaluations, and ensuring safety in clinical study design.

Provide strategic leadership for the development of consistent and accurate medical risk assessments throughout the product lifecycle.

Serve as a key resource in areas of MDR reporting, clinical research, and medical risk management.

Additional Responsibilities:

Evaluate clinical operations, product development, customer complaints, and post-market vigilance information to make judgments and assessments regarding patient safety, risk management, customer satisfaction, bioethics, and regulatory compliance. This requires balancing risk versus benefit and the standards of medical care.

Review and evaluate product performance data and trends to identify issues related to product performance or usage concerns early, minimizing clinical safety risk. This includes designing changes to product performance assessment and management to improve ongoing monitoring and risk assessment.

Interact with internal compliance organizations, FDA, and/or international regulatory bodies as required, in response to product performance inquiries and clinical study product performance matters, to enhance business growth opportunities.

Provide medical support to the Office of the Chief Medical Officer, including representing the Division at Medical Conferences, Sales Meetings, and Physician/Hospital interactions, as required by the DVP or MCSO Director or CMO.

Organize Medical Advisory Boards (specifically scientific elements and physician liaison) in conjunction with cross-functional stakeholders.

Required Qualifications

At least 10 years of experience in Clinical laboratory science with infectious diseases.

Bachelor's degree in science or similar background or an equivalent combination of education and work experience 

Travel requirement up to 30% to client sites.

Preferred Qualifications

Minimum 10 years Clinical laboratory experience 

Doctorate Degree or PhD. MD preferred. Must have focus on infectious diseases. 

At least 3 years of experience in the following areas: Providing medical oversight for on-market product and product performance functions, including monitoring product safety (e.g., complaints, MDRs), reporting, evaluation, and Health Hazard Evaluations, and ensuring safety in clinical study design, Providing strategic leadership for the development of consistent and accurate medical risk assessments throughout the product lifecycle, Serving as a key resource in areas of MDR reporting, clinical research, and medical risk management.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

The base pay for this position is $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.