Medical Affairs Scientist, Cardiac Imaging (Irvine, CA) Johnson and Johnson MedTech, Electrophysiology

Role Summary

Medical Affairs Scientist, Cardiac Imaging, to join our team in Irvine, CA. Role involves providing scientific insights through literature, supporting company-sponsored clinical trials and product evidentiary needs for safety and effectiveness assessments, and collaborating with R&D, Strategic Marketing, and Clinical Affairs to uncover gaps and generate evidence to support marketing messages.

Responsibilities

• Perform scientific exploration including systematic reviews, meta-analyses, and literature analysis to understand clinical and technological gaps, device evidence, or disease state reviews.
• Write and publish peer-reviewed pieces including abstracts, posters, and articles; present at conferences when possible.
• Provide insights to collaborating functions including R&D, GSM, HEMA, and CA.
• Support recruitment and mentoring of interns to increase scientific content exploration and publication.
• Support the study medical lead for company-sponsored clinical studies, assisting the clinical trial team to execute the study safely, effectively, and timely.
• Contribute to development and approval of clinical trial protocols, informed consents, investigator brochures, committee charters, and other study materials.
• Conduct routine review of adverse events, medical coding, source documents, and subject narratives.
• Contribute to drafting and review of study reports (APR, CSR) and other regulatory submissions.
• Support the evidence needs of technical documentation for new products in development and lifecycle management.
• Provide informed scientific input during study team meetings.
• Support generation of preclinical and clinical evidence strategies to support clinical claims and characterize product capabilities and clinical workflows with Marketing, R&D, and other teams.
• Support early product introduction to the market, launches, and internal/external training.
• Travel up to 25% of the time.
• Perform other duties as needed.

Qualifications

• A degree in science, engineering, or medicine is required; MS or PhD preferred.
• Cardiac imaging experience.
• Demonstrated experience in scientific research, publications, and presentations.
• A minimum of 2 years of clinical, engineering, or life science experience.
• Structural heart imaging including echocardiography and CT experience.
• Ability to communicate sophisticated scientific and medical information to diverse audiences.
• Experience with Medical/Clinical/R&D teams in a regulated medical device environment preferred.
• Strong interpersonal and scientific communication skills (written and verbal).
• Self-starter with ability to collaborate in a cross-functional team and work independently as needed.
• Project management, time management, organizational and prioritization skills; ability to manage multiple tasks.
• Reliability and flexibility in a fast-paced environment; team-oriented.
• Proficiency in Microsoft Office.

Education

• A degree in science, engineering, or medicine is required. Master of Science or PhD preferred.

Skills

• Analytical reasoning
• Clinical research and regulations
• Clinical trials operations
• Communication, stakeholder engagement
• Data analysis
• Digital literacy
• Medical affairs and medical communications
• Product development lifecycle
• Report writing
• Team collaboration