Senior Manager Medical Operations

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 122000 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. Youll 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 bachelors 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 Irving TX location in the Core Labs Division.
Our diagnostic solutions are used in hospitals laboratories and clinics around the globe. The crucial information derived from our tests instruments and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

About the Role
As the Sr. Manager Medical Operations you will lead medical affairs activities across the in vitro diagnostics (IVD) product lifecycle providing scientific and clinical expertise that supports product development regulatory compliance risk management and post-market activities. You will partner closely with R&D Regulatory Affairs Quality Clinical and Commercial teams to ensure clinical and medical considerations are effectively integrated into business decisions and product strategy.

What Youll Work On

The Senior Manager of Medical Operations (aka Medical Affairs) provides Medical and Clinical subject-matter knowledge and support to all product lifecycle activities and processes including new product development on-market projects/activities and risk management. This role helps maintain the medical perspective in all processes projects and initiatives which ensure the safety and performance of Abbott products throughout the lifecycle.

This is an excellent opportunity for a technical medical affairs leader who thrives at the intersection of clinical science risk management and diagnostic product innovation while influencing products from concept through commercialization and post-market support.

• Provide expert medical and clinical assessments of IVD products including assay performance clinical utility and patient impact ensuring medical requirements are incorporated throughout product development and lifecycle management.
• Serve as the subject matter expert for Medical Operations supporting both new product development and on-market products through clinical review evaluation and strategic guidance.
• Lead clinical safety and risk assessments contributing to key deliverables such as benefit-risk evaluations risk management documentation and clinical evidence packages.
• Represent Medical Operations in cross-functional project teams communicating medical insights and recommendations to stakeholders through presentations reviews and strategic discussions.
• Support investigations CAPAs complaints and field actions by providing medical review and clinical impact assessments in collaboration with Medical Directors and quality teams.
• Manage and prioritize Medical Operations activities ensuring effective execution of objectives workload distribution and team performance.
• Develop and deliver training programs that strengthen medical clinical and scientific capabilities across the organization.
• Drive continuous improvement initiatives by evaluating and enhancing medical operations processes procedures and systems.

Required Qualifications

• Doctorate Degree PhD in Life Sciences immunology or Clinical / translational research or MD
• Minimum 7 years of experience

Preferred Qualifications

• Advanced scientific clinical or medical background with expertise in IVD diagnostics medical devices biotechnology or life sciences.
• Strong knowledge of medical affairs clinical evaluation risk management product development and/or post-market surveillance activities.
• Experience supporting cross-functional teams in regulated healthcare environments.
• Proven ability to translate complex clinical and scientific data into actionable business recommendations.
• Strong leadership stakeholder management communication and presentation skills.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: 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 on LinkedIn at and on Facebook at

The base pay for this position is

$113300.00 $226700.00

In specific locations the pay range may vary from the range posted.

Medical & Scientific Affairs

CRLB Core Lab

United States > Irving : LC-02

Standard

Yes 15 % of the Time

Yes

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Driving a personal auto or company car or truck or a powered piece of material handling equipment Keyboard use (greater or equal to 50% of the workday) Work with human blood or other potentially infectious materials Work with infectious organisms or known infectious materials

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Senior Manager