Abbott Senior Clinical Research 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 107,000 colleagues serve people in more than 160 countries
Senior Clinical Research Scientist
Leading an active lifestyle is important to the many people we serve. In Abbott’s Electrophysiology & Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives.
As Senior Clinical Research Scientist, you will participate in the development of clinical evidence generation plans that describe the strategy, anticipated scope and projected timelines to develop all the clinical evidence needed to support a product/product family through its full lifecycle. This plan will outline the steps to establish feasibility, achieve regulatory approvals and meet ongoing regulatory requirements, gain reimbursement and support full commercial adoption. You will support the analysis and interpretation of scientific data and write clinical study protocols, reports and scientific publications. In this role, you will interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Risk Management, Reimbursement, Medical Affairs, Quality and Regulatory Affairs. You will also interact with global regulatory agencies to obtain market approval of new products and study sites to train on study protocols, obtain Ethics Committee / IRB approval and respond to questions throughout the study.
Primary Duties and Responsibilities
Comply with applicable Corporate and Divisional Policies and procedures.
Support the development of clinical strategy and study design.
Write study protocols, study reports, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
Support 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 at investigator meetings
Participate in and support audits.
Participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring.
Required Qualifications :
Bachelor’s degree in engineering, medicine, healthcare or sciences
5+ years of related research work experience
Demonstrated understanding of business environment and relates extensive knowledge of internal and external technological activities to trends.
Experience interfacing with senior management on significant matters, often requiring the coordination of activity across organizational units.
Ability to participate in the development of other technical contributors by facilitating training and providing feedback and guidance.
Ability to plan and organize project assignments of substantial variety and complexity.
Requires ability to be innovative, resourceful, and work with minimal direction
Requires 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.
Advanced degree in the sciences, medicine, or similar discipline highly 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.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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 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: _ www.abbottbenefits.com (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 (http://www.abbott.com/) , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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 email@example.com
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