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

Role Summary

Medical Affairs Scientist, Structural Heart to join our team in Irvine, CA. The role involves providing insights through literature and supporting company sponsored clinical trials and product evidentiary needs for safety and effectiveness assessments, collaborating with R&D, Strategic Marketing, and Clinical Affairs to identify clinical/technology gaps and publish in peer-reviewed journals.

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 possible.
• Provide insights to collaborating functions including R&D, Global Strategic Marketing, Health Economics and Market Access, and Clinical Affairs.
• Support recruitment and mentoring of interns (6‚Äì9 months) to increase scientific content exploration and publication.
• Support the study medical lead for company sponsored clinical studies, assisting the clinical trial team to execute 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 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 team members.
• 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

• Education: Degree in science, engineering, or medicine required; MS or PhD preferred.
• Experience: Minimum 2 years of clinical, engineering, or life science experience; structural heart interventions experience required.
• Skills: Ability to interpret and communicate sophisticated scientific/medical information to diverse audiences; strong interpersonal and scientific communication skills; proficient in Microsoft Office.
• Experience with Medical/Clinical/R&D teams in a regulated medical device environment is preferred.

Education

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

Skills

• Scientific research, publications, and presentations
• Literature reviews, meta-analyses, and systematic reviews
• Clinical trial support and documentation
• Cross-functional collaboration
• Project management and multi-task prioritization