Abbott
Overview
Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritionals and branded generic medicines. With 114,000 colleagues serving people in more than 160 countries, Abbott offers opportunities to grow, develop and make an impact. The Opportunity
This position works out of our Santa Clara, CA location in the Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease, including drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The Sr. Research Scientist provides scientific expertise throughout the development and implementation of clinical studies. Responsibilities include writing and managing clinical trial protocols, amendments, clinical study reports, trial registrations, results postings, study timelines and scientific publications; coordinating with cross-functional study support groups; interacting with regulatory agencies as needed; and providing strategic scientific communication to staff and study sites. What You’ll Work On
Facilitate development of clinical strategy and trial design by engaging with study PIs, key opinion leaders (KOLs) and cross-functional teams including Global Clinical Operations, Research & Development, Regulatory Affairs and Biostatistics. Write study protocols, protocol amendments, informed consents, study reports and publication materials; evaluate scientific literature and data to inform clinical practice. Present scientific data at industry gatherings, investigational meetings and regulatory agency meetings. Collaborate with R&D, Regulatory, Library Services, Product Performance Group, Quality Engineering, Clinical Affairs, CROs or Medical Writers, Training, Marketing and Sales, and senior management. Lead meetings and provide regular updates to senior staff. Create and manage clinical study timelines and budgets; manage vendor contracts as needed and ensure expenditures stay within budget. Work cross-functionally with clinical field teams and data management to identify missing data and monitor data completeness using metrics. Engage with external groups (e.g., core laboratories) to assess and interpret data when appropriate. Support regulatory submissions and communications with Regulatory Affairs, generating documents for submissions and responding to questions from authorities. Interpret results to support product applications by evaluating clinical, scientific and risk data and staying current with practice. Participate in and support audits. Demonstrate comprehensive knowledge of a particular technological field and how it relates to business unit functions; act as an expert within the workgroup and across functions. Operate in a quality system environment and recognize the importance of regulatory compliance. Tackle complex problems with in-depth analysis and apply judgment within defined practices to obtain results. Education and Experience You’ll Bring
Required Experience Bachelor’s degree in a related field Minimum 8 years of experience Experience in clinical trials within a regulated environment Experience in medical and scientific writing Comprehensive knowledge in a particular technological field Preferred Experience Familiarity with data analysis software (e.g., Excel, Tableau, Power BI) is highly desirable PhD, MD, PharmD or MSN preferred, or BA/BS with equivalent experience Apply Now * Participants who complete a short wellness assessment qualify for free coverage in our HIP PPO medical plan; coverage applies in the next calendar year. Learn more about our health and wellness benefits:
www.abbottbenefits.com 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. Compensation
The base pay for this position ranges from $86,700.00 to $173,300.00. In some locations, the pay range may vary. Job Details
Job Family: Clinical Affairs / Statistics | Division: AVD Vascular | Location: United States > Santa Clara: Building A - SC | Travel: Yes, 5% | Medical Surveillance: Not Applicable
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Abbott is a global healthcare leader with a portfolio spanning diagnostics, medical devices, nutritionals and branded generic medicines. With 114,000 colleagues serving people in more than 160 countries, Abbott offers opportunities to grow, develop and make an impact. The Opportunity
This position works out of our Santa Clara, CA location in the Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease, including drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The Sr. Research Scientist provides scientific expertise throughout the development and implementation of clinical studies. Responsibilities include writing and managing clinical trial protocols, amendments, clinical study reports, trial registrations, results postings, study timelines and scientific publications; coordinating with cross-functional study support groups; interacting with regulatory agencies as needed; and providing strategic scientific communication to staff and study sites. What You’ll Work On
Facilitate development of clinical strategy and trial design by engaging with study PIs, key opinion leaders (KOLs) and cross-functional teams including Global Clinical Operations, Research & Development, Regulatory Affairs and Biostatistics. Write study protocols, protocol amendments, informed consents, study reports and publication materials; evaluate scientific literature and data to inform clinical practice. Present scientific data at industry gatherings, investigational meetings and regulatory agency meetings. Collaborate with R&D, Regulatory, Library Services, Product Performance Group, Quality Engineering, Clinical Affairs, CROs or Medical Writers, Training, Marketing and Sales, and senior management. Lead meetings and provide regular updates to senior staff. Create and manage clinical study timelines and budgets; manage vendor contracts as needed and ensure expenditures stay within budget. Work cross-functionally with clinical field teams and data management to identify missing data and monitor data completeness using metrics. Engage with external groups (e.g., core laboratories) to assess and interpret data when appropriate. Support regulatory submissions and communications with Regulatory Affairs, generating documents for submissions and responding to questions from authorities. Interpret results to support product applications by evaluating clinical, scientific and risk data and staying current with practice. Participate in and support audits. Demonstrate comprehensive knowledge of a particular technological field and how it relates to business unit functions; act as an expert within the workgroup and across functions. Operate in a quality system environment and recognize the importance of regulatory compliance. Tackle complex problems with in-depth analysis and apply judgment within defined practices to obtain results. Education and Experience You’ll Bring
Required Experience Bachelor’s degree in a related field Minimum 8 years of experience Experience in clinical trials within a regulated environment Experience in medical and scientific writing Comprehensive knowledge in a particular technological field Preferred Experience Familiarity with data analysis software (e.g., Excel, Tableau, Power BI) is highly desirable PhD, MD, PharmD or MSN preferred, or BA/BS with equivalent experience Apply Now * Participants who complete a short wellness assessment qualify for free coverage in our HIP PPO medical plan; coverage applies in the next calendar year. Learn more about our health and wellness benefits:
www.abbottbenefits.com 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. Compensation
The base pay for this position ranges from $86,700.00 to $173,300.00. In some locations, the pay range may vary. Job Details
Job Family: Clinical Affairs / Statistics | Division: AVD Vascular | Location: United States > Santa Clara: Building A - SC | Travel: Yes, 5% | Medical Surveillance: Not Applicable
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