Job Information
Abbott Senior Clinical Affairs Scientist in Plymouth, Minnesota
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.
Senior Clinical Affairs Scientist
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.
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 high employer contribution
Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.
The Opportunity
The Senior Clinical Affairs Scientist will lead activities associated with clinical strategy in support of the Abbott’s electrophysiology (EP) medical device technologies. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. This individual will develop and implement clinical evidence generation strategies, including human clinical study design, execution, data analysis, and report creation. This role will collaborate internally with cross-functional partners (regulatory affairs, R&D, medical affairs, marketing) and externally with physician key opinion leaders (KOLs) and regulatory agencies to support regulatory approval and business needs for Abbott EP technologies.
This position can work out of our Plymouth, MN or St. Paul, MN location.
What You’ll Work On:
This position will participate in the development, collection, analysis, and dissemination of clinical evidence necessary to establish product feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and support commercialization of medical devices. As part of this, you will write clinical study protocols, reports, and will work closely with global competent authorities and investigational study sites to obtain clinical study approvals, Ethics Committee / IRB approval, and respond critically to questions raised throughout clinical study execution. In this role, you will also interact with physician Key Opinion Leaders and various internal cross-functional development teams throughout product development life cycle and will interact with global regulatory agencies to obtain market approval of new products and indications.
Participate in clinical trial design and protocol development.
Support clinical data collection, analysis, interpretation, and prepare clinical study reports
Generate and execute publication planning and study level publication projects.
Support pre-market and post-market regulatory submissions.
Facilitate communication between Sales and Marketing, R&D, Program Management, Reimbursement, Medical Affairs, Risk Management, Quality and Regulatory Affairs, and investigational sites.
Oversee study Steering Committees and Publication Committees, consisting of physician Key Opinion Leaders globally.
Present clinical study results to internal stakeholders and to physician partners at investigator meetings
Participate in and support audits.
Required Qualifications :
Advanced degree in the sciences, medicine, or similar discipline.
4+ years of clinical research work experience post-degree.
Demonstrated scientific writing ability.
Ability to plan and organize project assignments of substantial variety and complexity.
Ability to be innovative, resourceful, and work with minimal direction.
Excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Strong organizational and follow-up skills, as well as attention to detail.
Preferred
Experience in the medical device industry.
Experience with international medical device regulations and submissions.
Familiarity with relevant international regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
Experience working in a quality system environment preferred.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
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 , on LinkedIn at https://www.linkedin.com/showcase/abbott-cardiovascular/ and on X (Twitter) @AbbottNews and @AbbottGlobal.
The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com