Abbott Laboratories
Principal Clinical Scientist
Abbott Laboratories, Green Oaks, Illinois, United States,
Working at AbbottAt 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.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with a high employer contributionTuition 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 OpportunityThis position works out of our SH division.Structural Heart Business Mission: Why We ExistOur business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.As the Principal Clinical Scientist, you'll have the chance to work closely with the clinical study team including project management, biostatistician, data management, and other clinical study personnel. This position will have significant interaction with leadership and regulatory authorities. Furthermore, this position will be required to execute their job responsibilities within the corporate policies and standard operating procedures.What You’ll Work OnDevelops, writes, or mentors others in creation of clinical strategy, risk management, or clinical evaluation planning for products and process changes, to gain regulatory approval for product release, additional claims or indications, by addressing issues from a clinical, medical, and scientific perspective and by interacting with appropriate personnel.Develops, writes, or mentors others in generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms.Designs or mentors others in the design of clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, biostatistics data management, regulatory affairs, medical affairs as well as external stakeholders including steering and publication committees.Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy through coordination with investigator authors and internal teams.Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information.Review and critically analyze statistical analysis plans.Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.Required QualificationsAdvanced degree in the sciences, medicine, or similar discipline.8+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.Demonstrated scientific writing ability.Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.Independent decision making required.Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.Has broad knowledge of various technical alternatives and their potential impact on the business.Preferred QualificationsPhD degree in the sciences, medicine, or similar discipline preferred.Experience working on regulated, pre-market clinical studies preferred.Experience working in a quality system environment preferred.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow 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 X @AbbottNews.
#J-18808-Ljbffr
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 OpportunityThis position works out of our SH division.Structural Heart Business Mission: Why We ExistOur business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.As the Principal Clinical Scientist, you'll have the chance to work closely with the clinical study team including project management, biostatistician, data management, and other clinical study personnel. This position will have significant interaction with leadership and regulatory authorities. Furthermore, this position will be required to execute their job responsibilities within the corporate policies and standard operating procedures.What You’ll Work OnDevelops, writes, or mentors others in creation of clinical strategy, risk management, or clinical evaluation planning for products and process changes, to gain regulatory approval for product release, additional claims or indications, by addressing issues from a clinical, medical, and scientific perspective and by interacting with appropriate personnel.Develops, writes, or mentors others in generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study reports, clinical study protocols, case report forms, investigational brochures, and informed consent forms.Designs or mentors others in the design of clinical trials and studies in collaboration with internal stakeholders including clinical project management, clinical operations, biostatistics data management, regulatory affairs, medical affairs as well as external stakeholders including steering and publication committees.Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy through coordination with investigator authors and internal teams.Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information.Review and critically analyze statistical analysis plans.Generate documents to support regulatory submissions for Abbott products and/or respond to questions from regulatory authorities about existing submissions.Required QualificationsAdvanced degree in the sciences, medicine, or similar discipline.8+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.Demonstrated scientific writing ability.Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.Independent decision making required.Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.Has broad knowledge of various technical alternatives and their potential impact on the business.Preferred QualificationsPhD degree in the sciences, medicine, or similar discipline preferred.Experience working on regulated, pre-market clinical studies preferred.Experience working in a quality system environment preferred.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow 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 X @AbbottNews.
#J-18808-Ljbffr