Abbott

Senior Clinical Research Scientist

Posted on: 22 Jan 2021

Plymouth, MN

Job Description

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

JOB DESCRIPTION:

Senior Clinical Research Scientist

Leading an active lifestyle is important to the many people we serve. In Abbotts Electrophysiology & Heart Failure division, were 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:
* Bachelors 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.

Preferred
* 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

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.

JOB FAMILY:

Research and Discovery

DIVISION:

EPHF Electrophysiology & Heart Failure

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS:

United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza, United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive

WORK SHIFT:

Standard

TRAVEL:

Yes, 20 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott

Lake Bluff, IL

Abbott Laboratories discovers, develops, manufactures, and sells health care products worldwide. The company’s Established Pharmaceutical Products segment offers branded generic pharmaceuticals for the treatment of pancreatic exocrine insufficiency; irritable bowel syndrome or biliary spasm; intrahepatic cholestasis or depressive symptom; gynecological disorder; hormone replacement therapy; dyslipidemia; hypertension; hypothyroidism; Ménière's disease and vestibular vertigo; pain, fever, and inflammation; migraine; and anti-infective clarithromycin, as well as provides influenza vaccines and products that regulate physiological rhythm of the colon.

Its Diagnostic Products segment offers core laboratory systems in the areas of immunoassay, clinical chemistry, hematology, and transfusion; molecular diagnostics systems that automates the extraction, purification, and preparation of DNA and RNA from patient samples, as well as detects and measures infectious agents; cartridges for blood analysis; rapid diagnostics systems for infectious diseases; molecular point-of-care care testing for HIV, influenza A and B, RSV, and strep A; cardiometabolic test systems; drug and alcohol test systems, as well as remote patient monitoring and consumer self-test systems; and informatics and automation solutions for use in laboratories. The company’s Nutritional Products segment provides pediatric and adult nutritional products.

Its Cardiovascular and Neuromodulation Products segment offers rhythm management, electrophysiology, heart failure, vascular, and structural heart devices for the treatment of cardiovascular diseases, as well as neuromodulation devices for the management of chronic pain and movement disorders.

The company also provides glucose and blood glucose monitoring systems, including test strips, sensors, data management decision software, and accessories for people with diabetes. The company was founded in 1888 and is headquartered in Abbott Park, Illinois.

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