Medical Affairs Scientist, Structural Heart (Irvine, CA) Johnson and Johnson MedTech, Electrophysiology

Role Summary

Medical Affairs Scientist, Structural Heart position in Irvine, CA with Johnson & Johnson MedTech Electrophysiology. Focused on providing literature-based insights and supporting clinical trials and product evidentiary needs for safety and effectiveness, collaborating across R&D, marketing, and clinical affairs to address clinical and technology gaps.

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 as appropriate.
• Provide insights to collaborators in R&D, Global Strategic Marketing, Health Economics and Market Access, and Clinical Affairs.
• Support recruitment and mentoring of interns to increase scientific content exploration and publication.
• Support the study medical lead for company-sponsored clinical studies to execute studies 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.
• Draft and review study reports (annual reports, CSR) and other regulatory submissions.
• Support evidence needs of technical documentation for new products in development and lifecycle management.
• Provide informed scientific input during study team meetings.
• Contribute to generation of preclinical and clinical evidence strategies to support clinical claims and characterizing product capabilities and 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 required; Master of Science or PhD preferred.
• Structural heart interventions experience.
• Demonstrated experience in scientific research, publications, and presentations.
• A minimum of 2 years of clinical, engineering, or life science experience.
• Ability to understand, interpret, and communicate sophisticated scientific and medical information to diverse audiences.
• Experience working 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 across functions and work independently as needed.
• Project management skills to handle multiple projects; strong time management and prioritization.
• Reliable, adaptable to changing business needs, and team-oriented.
• Proficient in Microsoft Office.

Skills

• Scientific writing and publication
• Systematic reviews and meta-analyses
• Clinical trial support and documentation
• Cross-functional collaboration
• Adverse event review and medical coding
• Communication of complex scientific information

Education

• Bachelor‚Äôs degree in science, engineering, or medicine required; MS or PhD preferred.