Clinical Scientist II

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 109,000 colleagues serve people in more than 160 countries.

Structural Heart Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO
Provides scientific expertise throughout the development and implementation of clinical evaluations, risk management and /or clinical studies. Writes/manages clinical evaluation plans or clinical trial protocols, protocol amendments, risk master lists, clinical study project timelines, clinical evaluations (plans and reports), clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to assist in clinical strategy, the development of plans and reports, and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to staff as well as study sites as directed by your manager.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, Senior Management and investigational sites as directed by your manager. Conducts by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff.;

• Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
• Writes clinical evaluation plans and reports, study protocols, protocol amendments, informed consents, study reports, risk master lists, and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
• Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice.
• Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings.
• Participates in and supports audits.

Position Accountability / Scope:

Interfaces with management on significant matters, often requiring the coordination of activity across organizational units, physicians, and external CROs and medical writers. Participates in the development of other technical contributors by supporting training and providing feedback and guidance. May participate in a project team. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently. Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.

EDUCATION AND EXPERIENCE YOU'LL BRING

• Bachelor's degree required.
• Advanced degree highly preferred.
• Degree in the sciences, medicine, statistics, or related discipline preferred.
• Minimum of 3 years of related work experience with a substantial understanding of specified functional area, or an equivalent combination of education and work experience.

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.

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