Senior Scientist II

About the role

This position works out of our St Paul or Plymouth, MN locations, supporting our Electrophysiology medical device division within the Clinical Affairs function. The Senior Scientist II will lead scientific activities associated with the design, conduct, and reporting of clinical trials for this therapeutic area.

Responsibilities

• Participate in the development of clinical evidence to establish feasibility, achieve regulatory approvals, meet ongoing regulatory requirements, gain reimbursement, and support full commercial adoption of medical devices.
• Support the analysis and interpretation of scientific data and write clinical study protocols, reports, and scientific publications.
• Aid in the production of additional study-level documents including informed consent forms, case report forms, and investigator brochures.
• Interact with physician Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Field Operations, Risk Management, Reimbursement, Medical Affairs, Quality, and Regulatory Affairs.
• Interact with global regulatory agencies to obtain market approval of new products, and with study sites to respond to questions throughout the study.
• Participate in clinical trial design, protocol development, and publication planning.
• Generate and execute on study-level publication projects.
• Prepare clinical study reports or report sections.
• 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 to senior leaders and at investigator meetings.
• Participate in and support audits.

Requirements

• Advanced degree in the sciences, medicine, or similar discipline.
• 4+ years of clinical research work experience post-degree.
• Demonstrated scientific writing ability.
• Ability to plan and organize project assignments of substantial variety and complexity.
• Ability to be innovative, resourceful, and work with minimal direction.
• 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 Qualifications

• 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.
• Experience working in a quality system environment preferred.

Benefits

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

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